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OECD Unique Identifier details

BCS-GHØØ4-7
Commodity: Cotton
Traits: Glufosinate tolerance,Lepidoptera resistance
European Union
Name of product applicant: Bayer CropScience AG
Summary of application:

Genetically modified cotton line BCS-GHØØ4-7 expresses the PAT protein which confers tolerance to glufosinate-ammonium herbicides and the Cry1Ab protein which confers protection against certain lepidopteran pests.


Products:


1.) Foods and food ingredients containing, consisting of, or produced from BCS-GHØØ4-7 cotton
2.) Feed containing, consisting or produced from BCS-GHØØ4-7 cotton
3.) Products other than food and feed containing or consisting of BCS-GHØØ4-7 cotton for the same uses as any other cotton with the exception of cultivation

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Date of authorization: 24/04/2015
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): EU Register of authorised GMOs
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:
"Method for detection: Event specific real-time quantitative PCR based method for genetically modified BCS-GHØØ4-7 cotton Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003. Reference material: ERM-BF429 accessible via the Joint Research Centre (JRC) of the European Commission, the Institute for Reference Materials and Measurements (IRMM). Relevant links are provided below. "
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Opinion of the European Food Safety Authority
Method for detection
Reference material
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Authorization expiration date (a blank field means there is no expiration date) 26/04/2025
E-mail:
Organization/agency name (Full name):
European Union
Contact person name:
Alexandre Huchelmann
Website:
Physical full address:
European Commission B232 04/106 1047 Brussels
Phone number:
3222954092
Fax number:
Country introduction:

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

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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: Bayer CropScience Pty Ltd
Summary of application:
A genetically modified (GM) cotton line, T304-40, has been developed which is protected against feeding damage by Lepidopteran insects, particularly cotton bollworm (Helicoverpa spp.), and tolerant to herbicides containing glufosinate ammonium.
Protection against feeding damage by Lepidopteran insects is achieved through expressioni n the plant of an insecticidal Cry protein, Cry1Ab, encoded by a modified cry1Ab gene derived from the soil bacterium Bacillus thuringiensis, and tolerance to glufosinate ammonium is achieved through expression of phosphinothricin acetyltransferase (PAT) encoded by the bar gene derived from another soil bacterium Streptomyces hygroscopicus. Both of these genes have been widely used for genetic modification of a number of cropspecies.
The main food products derived from cotton line T304-40 would be oil and linters.
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Date of authorization: 20/05/2010
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 A1028 - Oil derived from Insect-resistant & Herbicide-tolerant Cotton Event T304-40
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Website:
Physical full address:
Level 4, 15 Lancaster Place, Majura Park ACT 2609, Australia
Phone number:
+61 2 6271 2222
Fax number:
+61 2 6271 2278
Country introduction:

Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 115 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 10 staff) is located in Wellington on the North Island.

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)

Canada
Name of product applicant: Bayer CropScience
Summary of application:

Bayer CropScience has developed cotton event T304-40 to be tolerant to glufosinate ammonium herbicides and resistant to lepidopteran pests. Recombinant DNA techniques were used to confer tolerance to the herbicide and impart pest resistance.

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Date of authorization: 09/05/2017
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.): BioTrack Product Database
Summary of the safety assessment (food safety):
Please see decision document weblinks
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Novel Foods Decision Document
Novel Feeds Decision Document
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Health Canada
Contact person name:
Neil Strand
Website:
Physical full address:
251 Sir Frederick Banting Driveway, Tunney's Pasture, PL 2204A1
Phone number:
613-946-1317
Fax number:
Country introduction:

Federal responsibility for the regulations dealing with foods sold in Canada, including novel foods, is shared by Health Canada and the Canadian Food Inspection Agency (CFIA). Health Canada is responsible for establishing standards and policies governing the safety and nutritional quality of foods and developing labelling policies related to health and nutrition. The CFIA develops standards related to the packaging, labelling and advertising of foods, and handles all inspection and enforcement duties. The CFIA also has responsibility for the regulation of seeds, veterinary biologics, fertilizers and livestock feeds. More specifically, CFIA is responsible for the regulations and guidelines dealing with cultivating plants with novel traits and dealing with livestock feeds and for conducting the respective safety assessments, whereas Health Canada is responsible for the regulations and guidelines pertaining to novel foods and for conducting safety assessments of novel foods.

The mechanism by which Health Canada controls the sale of novel foods in Canada is the mandatory pre-market notification requirement as set out in Division 28 of Part B of the Food and Drug Regulations.

Manufacturers or importers are required under these regulations to submit information to Health Canada regarding the product in question so that a determination can be made with respect to the product's safety prior to sale. The safety criteria for the assessment of novel foods outlined in the current guidance document (i.e. Canadian Guidelines for the Safety Assessment of Novel Foods) were derived from internationally established scientific principles and guidelines developed through the work of the Organization for Economic Cooperation and Development (OECD), Food and Agriculture Organisation (FAO), World Health Organisation (WHO) and the Codex Alimentarius Commission. These guidelines provide for both the rigour and the flexibility required to determine the need for notification and to conduct the safety assessment of the broad range of food products being developed. This flexibility is needed to allow novel foods and food products to be assessed on a case-by-case basis and to take into consideration future scientific advances.

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Relevant documents
Stacked events:

Food: Consistent with the definition of "novel food" in Division 28 of the Food and Drug Regulations, the progeny derived from the conventional breeding of approved genetically modified plants (one or both parents are genetically modified) would not be classified as a novel food unless some form of novelty was introduced into such progeny as a result of the cross, hence triggering the requirement for pre-market notification under Division 28. For example, notification may be required for modifications observed in the progeny that result in a change of existing characteristics of the plant that places those characteristics outside of the accepted range, or, that introduce new characteristics not previously observed in that plant (e.g. a major change has occurred in the expression levels of traits when stacked). In addition, the use of a wild species (interspecific cross) not having a history of safe use in the food supply in the development of a new plant line may also require notification to Health Canada. However, molecular stacks are considered new events and are considered to be notifiable as per Division 28.

Feed:

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

Neil Strand, Section Head of Novel Foods

Colombia
Name of product applicant: Bayern Crop Science
Summary of application:

Authorization of the genetically modified cotton T304-40 resistant to lepidoptera pest attack and tolerant to herbicide glufosinate

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Date of authorization: 27/09/2019
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Based on the risk assessment, it can be concluded that the event shows the same risks as its conventional counterpart. Therefore the National Technical Biosafety Committee for GMO use exclusively in Health and human consumption (CTNSalud) recommends its authorization.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministerio de salud y proteccion social
Contact person name:
Daniel Rubio
Website:
Physical full address:
Carrera 13 No. 32- 76 piso 12, Bogotá
Phone number:
330 5000 ext 1256
Fax number:
Country introduction:

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

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

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

Authorization of the genetically modified rice LLRICE601 resistant tolerant to herbicide glufosinate

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Date of authorization: 26/09/2008
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Based on the risk assessment, it can be concluded that the event shows the same risks as its conventional counterpart. Therefore the National Technical Biosafety Committee for GMO use exclusively in Health and human consumption (CTNSalud) recommends its authorization.
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministerio de salud y proteccion social
Contact person name:
Daniel Rubio
Website:
Physical full address:
Carrera 13 No. 32- 76 piso 12, Bogotá
Phone number:
330 5000 ext 1256
Fax number:
Country introduction:

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

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

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

T304-40 is a genetically modified cotton line protected against feeding damage by Lepidopteran insect larvae, and is also tolerant to herbicides containing glufosinate ammonium (modified bar, modified cry1Ab, Gossypium hirsutum L.).

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Date of authorization: 19/07/2013
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.): OECD BioTrack Product Database
Summary of the safety assessment (food safety):
Please see the links 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 Food Safety Commission of Japan (in Japanese), Food
Food safety assessment performed by Food Safety Commission of Japan (in Japanese), Feed
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Food Safety Commission Secretariat,Cabinet Office,
Contact person name:
Mariko Murakami
Website:
Physical full address:
Akasaka 5-2-20 Minato Ward,Tokyo,Japan
Phone number:
81 3 6234 1122
Fax number:
81 3 3584 7392
Country introduction:
Safety assessments of GM foods are mandatory under the Food Sanitation Law in Japan. The Ministry of Health, Labour, and Welfare (MHLW) legally imposes safety assessments of GM foods so that those that have not undergone safety assessments would not be distributed in the country. MHLW receives application and requests the Food Safety COmmission of Japan (FSCJ) to evaluate the safety of GM foods in terms of human health. Safety assessments are carried out by FSCJ.
Useful links
Relevant documents
Stacked events:

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

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

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

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

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

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

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

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

Malaysia
Name of product applicant: Bayer Co. (Malaysia) Sdn. Bhd.
Summary of application:

Please refer to the decision document of the National Biosafety Board

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Date of authorization: 30/03/2017
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.): Malaysia Biosafety Clearing House
CBD Biosafety Clearing House
Summary of the safety assessment (food safety):
Please refer to the Risk Assessment Report
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Department of Biosafety Malaysia
Contact person name:
Dr. Anita Anthonysamy
Website:
Physical full address:
Department of Biosafety Ministry of Environment and Water Level 4, Block F11, Complex F Lebuh Perdana Timur, Precinct 1 62000 Putrajaya, Malaysia
Phone number:
+60388861153
Fax number:
+60388904935
Country introduction:

GM food safety assessment is a requirement by law under the Biosafety Act 2007 in Malaysia. The National Biosafety Board reviews and makes decisions on events based on a scientific/technical risk assessment, policy considerations as well as public input. The decisions and its related documents made are publicly available through the Malaysian Department of Biosafety Website and the Convention of Biological Diversity Biosafety Clearing House.

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

Department of Biosafety Malaysia, Level 1, Podium 2, Wisma Sumber Asli No. 25, Persiaran Perdana, Precinct 4 Putrajaya, Federal Territory Malaysia, 62574. Phone: +603 8886 1746 / 1579. Fax: +603-8889 5604 Email: [email protected] Url: www. biosafety.gov.my

 

Food Safety and Quality Division, Ministry of Health, Level 4, Menara Prisma, No. 26, Persiaran Perdana, Putrajaya, Malaysia, 62675. Phone: +603 88850797 Fax: +603 88850790 Email: [email protected]
New Zealand
Name of product applicant: Bayer CropScience Pty Ltd
Summary of application:

A genetically modified (GM) cotton line, T304-40, has been developed which is protected against feeding damage by Lepidopteran insects, particularly cotton bollworm (Helicoverpa spp.), and tolerant to herbicides containing glufosinate ammonium.
Protection against feeding damage by Lepidopteran insects is achieved through expressioni n the plant of an insecticidal Cry protein, Cry1Ab, encoded by a modified cry1Ab gene derived from the soil bacterium Bacillus thuringiensis, and tolerance to glufosinate ammonium is achieved through expression of phosphinothricin acetyltransferase (PAT) encoded by the bar gene derived from another soil bacterium Streptomyces hygroscopicus. Both of these genes have been widely used for genetic modification of a number of cropspecies.
The main food products derived from cotton line T304-40 would be oil and linters.

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Date of authorization: 15/07/2010
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): OECD BioTrack Product Database
Summary of the safety assessment (food safety):
FSANZ has completed a comprehensive safety assessment of food derived from cotton plants containing event T304-40. This assessment included consideration of (i) the genetic modification to the plant; (ii) the potential toxicity and allergenicity of the novel proteins; and (iii) the composition of cotton line T304-40 compared with that of conventional cotton cultivars. No public health and safety concerns have been identified in this pre-market safety assessment of food derived from cotton line T304-40. On the basis of the available evidence, including detailed studies provided by the Applicant, food derived from cotton line T304-40 is considered as safe and wholesome as food derived from other commercial cotton cultivars.
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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 A1028 - Oil derived from Insect-resistant & Herbicide-tolerant Cotton Event T304-40
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministry for Primary Industries
Contact person name:
Fiapaipai Auapaau
Website:
Physical full address:
Pastoral House, 25 The Terrace, Wellington, 6012
Phone number:
+6448314946
Fax number:
Country introduction:

New Zealand and Australia share a joint food regulation system for the composition of labelling of most foods. Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of the joint food standards in Australia and New Zealand. The main office (approximately 120 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 15 staff) is located in Wellington on the North Island.

Useful links
Relevant documents
Stacked events:

FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)

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

Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)

Philippines
Name of product applicant: BASF Philippines
Summary of application:

 


On December 7, 2016, Bayer Crop Science Philippines Inc.’s application for cotton T304-40 for direct use as food and feed, or for processing, as original application under the DOST-DA-DENR-DOH-DILG Joint Department Circular (JDC) No. 1 Series of 2016.  After reviewing the Risk Assessment Report and attachments submitted by the applicant, the assessors namely: Scientific and Technical Review Panel (STRP), BPI Plant Products Safety Services Division (BPI-PPSSD) and Bureau of Animal Industry- Biotech Team (BAI-BT), concurred that cotton T304-40 is as safe for human food and animal feed as its conventional counterpart.

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Date of authorization: 19/11/2018
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):
STRP ASSESSMENT AND RECOMMENDATIONS Based on the documents submitted by the applicant: Host Organism The STRPs reported that cotton is a key source of nutrients and farms animals as presented in a science-based consensus document from OECD. Adequate data was presented on the typical levels of antinutrients that are present, with the expert remarking that free gossypol in cottonseed is highly reduced to very low or undetectable amounts in oil and that appropriate control measures are given to ensure the safety of consumers. They also reported that the host organism is not a known source of allergens. Cottonseed products consumed as feeds for animals Transgenic Plant Cotton is not a known source of allergens. According to the STRP, adequate onformation on the final form of the consumed food product has been provided by the applicant, together with a list of countries that have approved the use of this transgenic plant as food and as feed Donor Organism ( Bacillus thuringensis sp., Steptomyces hygrospicus) Adequately documented in both cross references was provided to describe the donor organism. The inserted regulatory sequences were adequately described. Cry1Ab the overall homology search with general protein database showed mainly similarities with other acetyltransferases from various bacterial origin. No allergic nor toxicological in silico findings associated with PAT/bar proteins was found. It was noted by the STRPs that the Cry1Ab protein has been in use for more than ten years in genetically modified crops. The source of bar protein with which he overall homology search with general protein database showed mainly similarities with other and no allergenic or toxicological homology were associated with the protein. The donor organism have no known allergenic and pathogenic effects on human, animals and non-target organisms. Transformation System The STRPs reported that transformation was agrobacterium mediated and that the nuclear DNA was the target of modification. The genetic description of calli production experimental protocol including cali production and cell suspension was described by the applicant. A complete map of the plasmid vector is provided including the restriction site location of genetic elements Inserted DNA Genetic Stability Southern blot analysis sufficiently demonstrated the integrity of the inserted DNA sufficiently demonstrating that there were no truncations deletions and rearrangements. Bioinformatic analysis indicated that there were were no potential novel chimeric ORFs therefore, eliminating the possibility of creating a new protein and that the absence of the vector backbone was also demonstrated using this technique Multi generational stability of the induced trait was presented by the banding patterns of southern blots from plants from different generations. Inheritance for single gene locus and stability of the T304-40 insert was demonstrated. Expressed Material The mechanism of action of the Cry1Ab is apply described and in a similar to the known mechanism of action on lepidopteran larvae. The presented study by the applicant has described and characterized the metabolic pathways involved in the expression of the Cry1Ab protein. It was noted by the STRP that Cry1Ab has received regulatory approval by several countries in the late 1900s. The PAT protein was present in all plant parts at different growth stages which is due to the action of the constitutive promoter driving the constitutive expression of the protein in all plant tissues. The provided reference by the applicant sufficiently provides data on the characterization and mode of action of the PAT proteins. Toxicological Assessment The STRPs noted that the Cry1Ab protein was degraded very rapidly in human simulated gastric fluid, within 2 minutes of incubation in the presence of pepsin. SDS-PAGE analysis sufficiently demonstrated the rapid degradation of Cry1Ab protein in SGF. When the protein was subjected to high temperatures, the STRP noted that the the observed bands after heating can be explained in terms of partial denaturation and agglutination and that supporting evidence was cited with respect to non-correlation of possible allergenicity/toxicity with protein stability. Homology search on the protein databases was sufficient to show no known homology with toxins Allergenicity Assessment Cry1Ab SDS-PAGE analysis shows that the Cry1Ab protein was rapidly degraded in the presence of simulated gastric fluid and simulated intestinal fluid. Homology search performed was sufficient to show that there is no homology with known allergens. The data provided shows that the protein is not glycosylated and that the protein is not detectable or present on the cottonseed oil. PAT The STRPs reported that the data presented sufficiently shows that the PAT protein was completely and rapidly degraded after a few second incubation in SGF and SIF. The protein was inactivated but not degraded by high temperatures. The use of three databases showed no similarities with known allergens. The data provided also shows that the PAT protein is not detectable or present in cottonseed oil. Nutritional Data The mean values obtained for proximate and fiber compounds in fuzzy cottonseed of T304-40 falls within the reference range. Transgenic cotton values obtained for proximate fiber compounds fell within the range reported for commercial varieties. Biological relevance was shown by comparing values obtained with the reference commercial values. The STRPs support the findings that the processing of cottonseed to oil removes the CPFs and that values reported for the same antinutrients from transgenic cotton were within the range reported in literature. Recommendation After thorough and scientific review and evaluation of the documents provided by the Bureau of Plant Industry relevant to the transformation event Cotton T304-40 of Bayer CropScience, Inc., STRPs did not find any information pertaining to relevant differences between the the safety and nutritional quality of the said event in comparison with its conventional counterpart. There were no evidence of potential toxic or allergenic attributes to cotton T304-30 as food, feed or for processing. BPI-PPSSD ASSESSMENT AND RECOMMENDATION Upon evaluation of the documents provided by the proponent for the food safety risk assessment of Cotton T304-40 the following assessments were made: Host Organism (Zea mays L.) The developer provided sufficient data that cotton is a source of nutrients, as well as source of oil derived from cottonseed which can be consumed by humans and proteins present in cottonseed cake and meal making it appropriate as livestock feed. Antinutrients are also present cotton as a host organism and contains cyclopropenoid fatty acids like sterculic, malvic and dihydrosterculic acids. Sufficient information was also provided on cotton’s use as food and feed. The presence of cottonseed meal is an excellent source of protein for ruminant animals, most often used in dairy feed than in beef and sheep feed. Cotton seed hulls are very palatable for ruminant animals and are commonly used in combination with limited amounts of corn silage or hay. Transgenic Plant (Cotton T304-40) The developer provided sufficient data and reference regarding the list of countries that have approved cotton as food which are Australia/New Zealand, Brazil, Canada, Japan, Korea, Mexico, Taiwan and the United States of America. The developer has provided sufficient that the consumption pattern will not change. Donor Organisms ( Bacillus thuringensis, Streptomyces hygroscopius) The developer provided sufficient information and reference about the protein encoding sequences found in the original gene construct and it was described with respect to source and potential pathogenic or allergenic properties. Inserted regulatory sequences of the cry1Ab gene and the bar gene were adequately described. Bacilllus thuringiensis subsp. Berliner is a common bacteria in the environment and its naturally occurring isolates have been used for insect control for decades with no safety concerns. Streptomyces hygroscopicus is not known to be a human, animal or plant pathogen nor has it been associated with other properties known to affect human health. History of safe use was attributed to both donor organisms. Expressed Material (Cry3Bb1 and CP4 EPSPS) The developer presented researches on the level of expression of the Cry1Ab and PAT in different plant parts like roots, stems, leaves, whole plant, squares, bolls, pollen, nectar, flowers and grains. . The amounts of PAT/bar protein and Cry1Ab protein were measured in these plant parts from T304-40 and Coker 315. Toxicological Assessment Digestibility study was performed in human simulated gastric fluid containing pepsin with varying incubation time at pH 1.2 and SDS-PAGE analysis was used to show the degradation of the protein. The Cry1Ab protein was degraded very rapidly with no residual protein being visible at 2 minutes of incubation with SGF, in presence of pepsin, at pH 1.2. There was no significant digestion at pH 1.2 in the absence of pepsin, showing that digestion requires pepsin. Heat inactivation studies demonstrated that Cry1Ab protein was markedly degraded after 60 minutes at 90°C. The PAT/bar protein was degraded very rapidly in human simulated gastric fluid. Results of Western Blot Analysis showed that 90% of the PAT protein is readily digested in less than a minute upon incubation with pancreatin. After heat treatments, there were no visible changes to the PAT/bar band intensities similar to the unheated sample. As a conclusion, there are no toxicological in silico finding associated with PAT protein. Acute oral gavage was performed and no mortalities, no treatment-related clinical signs, no effects on body weight and food consumption parameters and no macroscopic changes that were observed on the mice after acute oral administration of PAT protein at 2000 mg/kg body weight. The PAT protein purified from T304-40 cotton leaves and from E. coli,was assessed for comparability by means of SDS-PAGE and was found to similar. The BPI-PPSSD has reported that the novel proteins are expressed independently of each other. As in the case of majority of the plant proteins, both proteins were translated in the cytoplasm. There are no expected interaction between the insect resistance and herbicide tolerance traits due to their differences in mode of actions and metabolic pathway. Allergenicity Assessment Cry1Ab protein was also subjected to digestibility study using SIF with pancreatin at pH 7.5. Results showed that Cry1Ab protein is readily digested at 30 seconds upon incubation with pancreatin. Cry1Ab protein was markedly degraded after 60 minutes at 90°C.The Cry1Ab protein may be only slightly degraded up to 60 minutes at 90°C, and may be agglutinated and become insoluble after 30 to 60 minutes at 90°C. The developer provided sufficient information and presented a bioinformatics study to evaluate potential amino acid sequence similar to Cry1Ab with known allergens using in silico method. The PAT protein was very rapidly and completely degraded in human simulated gastric fluid, within few seconds of incubation, in the presence of pepsin, at pH 1.2. The PAT protein was completely thermo-inactivated after 10 minutes at 55oC and higher temperatures despite the fact that the protein was not degraded. There are no allergenic in silico findings associated with the PAT/bar protein. The main product derived from cottonseed in human consumption is cottonseed oil. Last traces of protein in the crude oil are removed in the alkali treatment and deodorization steps of the oil refining. This was confirmed by the absence of any detectable or quantifiable PAT/bar protein amounts in crude and food grade oil produced from T304-40 cotton seeds. The main product derived from cottonseed in human consumption is cottonseed oil. Last traces of protein in the crude oil are removed in the alkali treatment and deodorization steps of the oil refining. This was confirmed by the absence of any detectable or quantifiable Cry1Ab protein amount in crude and food grade oil produced from cotton event T304-40 seeds. No serum screening was performed. Nutritional Data The composition of T304-40 cotton is evaluated to determine if it is nutritionally equivalent to its non-GM cotton variety Coker 315 as well as other varieties available in the market. Proximate analysis was done for the comparison of nutritional values. The developer provided sufficient data with regards to the comparison of key nutrients of GM and non-GM groups. Comparisons included the results from reference ranges compiled from cotton literature. Substantial equivalence in the chemical composition is established, if the levels and variations of the nutrients and anti-nutrients of the GM crop are within the natural or experimental variability for the respective nutrients and anti-nutrients in the non GM comparator grown under the same regimes and environmental conditions. The differences that were detected for phytic acid either in the over-all sites or in the by-site statistical analyses have no biological and nutritional relevance because the mean values calculated for the GM groups are inside or in good compliance with the references ranges for commercial cotton seeds, the estimated differences between treatments are very small for most compounds and the content of the anti-nutrients is slightly lower in the GM samples, so that nutritional deficiencies cannot be expected. After heat treatment, anti-nutrients notably decrease up to 90%. Only the oil moiety and to some extent the linters of the seeds will, after processing, enter the human food chain since cotton is not used for direct consumption. The biological and nutritional relevance of some statistically significant differences found between the non-GM control and T304-40 cotton were negligible. There is no safety issue related to the consumption of T304-40 seed since the contents of all nutrients are comparable to the contents in seeds from other commercial cotton varieties. Conclusion Various tests were conducted to evaluate if T304-40 cotton is compositionally and nutritionally comparable to its non-GM counterpart such as variety of Coker 315 and other commercially available cotton varieties. Proximate and fiber analysis was done, micro-nutrients analysis such as minerals and alpha tocopherol, anti-nutrients free and total gossypol, phytic acid and cyclopropenoid fatty acids, total amino acid and total fatty acids percentage were also gathered. Average values determined from composition analyses of T304-40 and Coker 315 cotton seeds were compared to reference ranges taken from different chemistry reference guidelines. Most of the values obtained were within the reference ranges obtained from the literatures. For most of the analyzed components no differences between the GM and non-GM control products were observed. If differences were noticed this has no nutritional impact, for various reasons. Most analyzed values for the GM products are inside the reference range for the commercial products. If differences to the reported ranges are noticed this is in most cases also true for the non-transgenic product and therefore not an effect of the genetic modification of the cotton seeds. Differences in nutrient levels were only found in one product, but not in the raw agricultural commodity and in the intermediate. Differences in nutrient levels are too small for having a nutritional. According to the presented statistical evaluation of the analytical data and an assessment of the nutritional impact of the different observations, the seeds from T304-40 cotton and the products derived from them are found to be nutritionally equivalent to their traditional non-GM counterpart. There is no impact on the nutritional value of the cotton seeds as a result of the genetic modifications. BAI ASSESSMENT AND RECOMMENDATIONS Based on the documents submitted by the applicant, BAI made the following assessment: Host Organism Cotton is a source of key nutrients for both human & livestock and cottonseed oil is the main product for human consumption. The by-product from oil extraction is cottonseed meal that contains large amounts of protein and is the main product for use as feed for livestock. Cotton contains anti-nutrients including several cyclopropenoid fatty acids and other compounds like flavonoids, tannins, and anthocyanin. Most of these are inactivated during processing. Cotton is not a source of allergens and cottonseed oil has a long history of safe use. The main cotton by-product used as food for human consumption is cottonseed oil which is a pure source of fatty acids. Raw cotton products contain non-glyceride materials and other genetic materials or proteins and are mostly inactivated or removed during processing. Whole cottonseed and cottonseed hulls are used as feed for ruminant animals. One of the by-products from cottonseed processing is cottonseed meal which is an excellent source of protein and is the main cottonseed product used as feed for livestock. Transgenic Plant The countries that have authorized T304-40 cotton for use as food are Australia, New Zealand, Brazil, Canada, Japan, Korea, Mexico, Taiwan, and the U.S. BAI states that consumption patterns are not expected to change across popu;ation sub groups as a result of introducing the novel food. The countries that have authorized T304-40 cotton for use as feed are Brazil, Canada, Japan, Korea, Mexico, and the United States of America. Donor Organism (Scientific name: Bacilllus thuringiensis, Streptomyces hygroscopicus) BAI reported that protein-encoding sequences and inserted regulatory sequences were adequately described. Bacillus thuringiensis subsp. berlineris known to have toxic properties mainly directed to a particular group of insects making it useful as a source of biological pest control agents. Streptomyces hygroscopicusis not known to be pathogenic, toxic, or allergenic. Both proteins are not known to be toxic or allergenic Transformation System The Agrobacterium tumefaciens transformation system was used in this event with the Nucleus cotton variety Coker 315 as recipient. The experimental protocols are completely provided and each genetic elements in the plasmid map were adequately described. Inserted DNA The obtained data from the Southern Blot analysis has sufficiently demonstrated that the inserted transgenic sequence in the transformation event T304-40 consist of only one insertion site. Aside from cotton and other cotton stacks, Cry1Ab is also expressed in several GM maize products that have been given approval by various regulatory authorities, while the PAT protein is expressed in several other transformation events in eigth species of plants namely sugarbeet, oilseed rape, bird rape,chicory, soybean, rice, and corn. Genetic Stability and Expressed Material Southern blot analysis confirmed the molecular stability of event T304-40 across four generations. As mentioned in the documents presented, the novel proteins do not have a metabolic role. Toxicological Assessment Cry1Ab Pepsin enzyme was used in the digestibility study in human Simulated Gastric Fluid (SGF). After 2 minutes of incubation, Cry1Ab protein was rapidly digested after incubation in SGF. SDS-PAGE analysis was used to determine the fragments remaining after digestion. Within two minutes was degraded rapidly with no residual protein being visible. Pancreatin enzyme was also used in the digestibility study in Simulated Intestinal Fluid (SIF) and the Western Blot analysis revealed that the degradation is stable after 60 minutes of incubation. Bioinformatic analysis was conducted to evaluate the potential amino acid sequence. and No toxicological findings were found. Acute oral toxicity of Cry1Ab was administered to mice by oral gavage 2000mg/kg bodyweight and there were No signs of systemic toxicity in the mice observed. Escherichia coli was the source of protein and its equivalency was assessed for comparability by means of SDS-PAGE and Western blot. PAT protein Pepsin was the enzyme used in the digestibility study in human Simulated Gastric Fluid (SGF). After 30 seconds of incubation PAT protein was degraded rapidly in SGF. The samples were analyzed by Coomassie blue-stained SDS-PAGE and Western blot. Pancreatin enzyme was also used in the digestibility study using Simulated Intestinal Fluid and results show the complete digestion of PAT protein in less than 30 seconds upon incubation. Heat inactivation studies have reported that PAT protein was heat stable up to 60 minutes of incubation at 90°C. By means of Coomassie blue-stained SDS-PAGE and Western blot. Bioinformatic analysis led to a finding that no biologically relevant identities were found with any toxic proteins. Escherichia coli used as the source of test protein and comparability was assessed by means of SDS-PAGE, Western blot, glycostaining, peptide mapping, N-terminal sequencing and activity measurement. The proteins are expressed independently of each other with their respective functional activity maintained. Both proteins are expressed in the cytoplasm, do not interact to express the phenotypes and do not interact in a metabolic pathway. Allergenicity Assessment The digestibility study of Cry1Ab protein in SGF using the enzyme pepsin, and in SIF using the enzyme pancreatin showed different results. The half-life of Cry1Ab in SGF using pepsin at pH 1.2 is 2 minutes with complete, rapid degradation of the protein. The result in SIF with pancreatin at pH 7.5 demonstrated incomplete degradation of the protein. Both SDS-PAGE and Western Blot analysis revealed the largest size of remaining fragments to have a molecular weight of 66.3 kDa. Both SDS-PAGE and Western Blot analysis have similar results demonstrating that Cry1Ab protein is heat stable up to 75oC in 30 minutes with only slight degradation of the protein in higher temperatures. The homology of the protein sequence with that of sequences with the similarities are not biologically significant to known allergens from the AOL database. Cry1Ab protein has an identity match with Cry proteins from Bacillus thuringiensis with a best score of only 31.7% identity over 60 amino acids. Therefore, these results did not meet the matching criterion for an allergen based on a 35% identity over an 80 amino acid segment. Cry1Ab has 7 potential N-glycosylation sites identified but are not necessarily predictive of glycosylation and therefore not conclusive to identify Cry1Ab as a glycosylated protein. There is no detectable or quantifiable Cry1Ab protein amount in crude and food grade oil produced from cotton event T304-40 seeds. PAT protein DS-PAGE and Western blot analysis both have similar half-life results of 30 seconds for the digestibility study of PAT protein in SGF using the enzyme pepsin at pH 1.2 and in SIF using the enzyme pancreatin at pH 7.5 with complete degradation of the protein after digestion. SDS-PAGE and Western Blot analysis both demonstrated an observed half-life of PAT protein at 90oC in 60 minutes. PAT protein has no relevant homology with any known allergen. No detectable PAT protein amounts in both crude and food grade oil produce from event T304-40 cottonseed. Statistical difference is not biologically relevant. Nutritional Data Statistically significant differences were found either in the over-all sites or in the by-site analyses for ash, calcium, dihydrosterculic acid, and a number of fatty acids. The estimated differences between treatments are very small for most compounds and very often lower than the variation inside the transgenic control group. Comparison with a range of four varieties were done and the data derived from the transgenic line were within the observed range. Levels of gossypol are reduced in food and feed products. Gossypol is detoxified by combination of heat and moisture during processing steps. Recommendation Thorough and scientific review and evaluation of the documents provided by __Bayer Crop Science, relevant to Cotton T304-40 the undersigned BAI Biotech Team find scientific evidence that the regulated article applied for human food animal feed use is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health.
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Authorization expiration date (a blank field means there is no expiration date) November 18, 2023
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Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Geronima P. Eusebio
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Physical full address:
San Andres St., Malate, Manila
Phone number:
632 404 0409 loc 203
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Country introduction:

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

 

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Stacked events:

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

 

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

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

(a) genetic engineering, or

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

Plant Products Carrying Stacked Genes Conferred through Conventional Breeding:

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

Notificatlon Requirement for Plant Products Carrying Stacked Genes

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

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

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

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

Singapore
Name of product applicant: Bayer CropScience
Summary of application:

Apply for use as food, feed and for processing 

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Date of authorization: 02/11/2020
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):
Cotton line T304-40 (BCS-GH004-7) has been generated to protect against Lepidopteran insect larvae, and also tolerant to herbicides containing glufosinate ammonium. Insect protection is conferred by expression of a modified Cry1Ab protein from Bacillus thuringiensis and herbicide tolerance is conferred by expression of phosphinothricin acetyltransferase (PAT) from Streptomyces hygroscopicus. Cotton line T304-40 contains two novel genes cassettes. One contains a modified cry1Ab gene that encodes an insecticidal crystal protein and the other contains a bar gene that encodes a protein conferring tolerance to herbicides containing glufosinate ammonium. Molecular analyses of cotton line T304-40 indicate that there is a single insertion site containing two almost complete copies of the cry1Ab cassette, an almost complete copy of the bar cassette and an isolated partial terminator sequence from the cry1Ab cassette. The introduced genetic elements are stably inherited from one generation to the next. The Cry1Ab and PAT proteins are unlikely to be toxic or allergenic to humans. Compositional analyses showed that the key constituents in seed from cotton line T304-40 are similar to conventional cotton cultivars. Food derived from cotton line T304-40 is considered as safe as food derived from conventional cotton cultivars.
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Organization/agency name (Full name):
Agri-Food & Veterinary Authority of Singapore (AVA)
Contact person name:
Dr Wong Kwok Onn
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52 Jurong Gateway Road, #14-01, Singapore 608550
Phone number:
(65)68052895
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Country introduction:

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

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Stacked events:

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

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

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

Singapore Food Agency (SFA)

United States of America
Name of product applicant: Bayer CropScience USA LP
Summary of application:

Cotton
Trait 1 Added Protein or DNA: Cry1Ab
Source: Bacillus thuringiensis subsp. berliner
Intended Effect: Resistance to lepidopteran insects
Trait 2 Added Protein or DNA: Cry2Ae
Source: Bacillus thuringiensis subsp. dakota
Intended Effect: Resistance to lepidopteran insects
Event Designation: T304-40

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Date of authorization: 26/01/2012
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 website 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:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: FDA's webpage regarding this variety
EPA Registered Plant Incorporated Protectants
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Organization/agency name (Full name):
Food and Drug Administration
Contact person name:
Jason Dietz
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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.

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Stacked events:

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

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

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