| Commodity: |
Soyabean / Soybeans |
| Traits: |
Lepidoptera resistance |
| Name of product applicant: |
Monsanto Argentina S.A.I.C. |
| Summary of application: |
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| Date of authorization: |
26/01/2018 |
| 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.): |
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| Summary of the safety assessment (food safety): |
• Inheritance studies conducted indicated that Mendelian segregation exists. • New expression proteins are expressed in low levels. • It is compositionally equivalent to its non-transgenic counterpart. • No evidence of similarity or homology was found with known toxic proteins. • There is no evidence of expression of known allergenic substances for the proteins expressed in the event. It is concluded that the event is substantially equivalent to its conventional counterpart, therefore, it is as safe and no less nutritious than conventional commercial varieties. |
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
GMO commercial approvals in Argentina
GMO approvals for food/feed
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E-mail:
Organization/agency name (Full name): Ministerio de Agroindustria
Contact person name: Andrés Maggi
Website:
Physical full address: Paseo Colón Avenue 367, 3° floor, City of Buenos Aires
Phone number: 54 11 5222 5986
Fax number:
Country introduction: In Argentina, the food and feed risk assessment process of transformation events, as the result of modern biotechnology, is carried out by the National Service for Agrifood Health and Quality (Senasa). The General Office of Biotechnology, is the area responsible for carrying out this task. It has an specific professional team and the advise of a Technical Advisory Committee composed of experts from several scientific disciplines representing different sectors involved in the production, industrialization, consumption, research and development of genetically modified organisms. Useful links
Relevant documents
Stacked events: Stacked events with all single events approved, are assessed as a new event, but with much less requirements, always on a case-by-case basis. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: National Service for Agrifood Health and Quality (Senasa)
https://www.argentina.gob.ar/senasa
https://www.argentina.gob.ar/senasa/programas-sanitarios/biotecnologia
| Name of product applicant: |
Monsanto Australia Ltd |
| Summary of application: |
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| Date of authorization: |
14/01/2016 |
| Scope of authorization: |
Food |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
OECD BioTrack Product Database
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| 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: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
A1110 - Food derived from Insect-protected Soybean Line MON87751
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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: |
Monsanto Australia Ltd |
| Summary of application: |
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| Date of authorization: |
14/01/2016 |
| Scope of authorization: |
Food |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
OECD BioTrack Product Database
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| 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: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
A1110 - Food derived from Insect-protected Soybean Line MON87751
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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: |
Monsanto do Brasil Ltda. |
| Summary of application: |
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| Date of authorization: |
28/06/2017 |
| 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.): |
ISAAA
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| Summary of the safety assessment (food safety): |
The studies carried out indicated that pleiotropic and epistatic effects were not observed in the morphological and agronomic character evaluation tests performed with soybean MON 87751 in Brazil in the harvest of 2013/2014. The agronomic characteristics of MON 87751 soybean were not altered in relation to Commercial varieties, except for the expression of the insect resistance characteristic, which was the objective of introducing the cry1A.105 and cry2Ab2 genes into the soybean genome.
The characteristic conferred by the introduction of the cry1A.105 and cry2Ab2 genes is not expected to provide any competitive advantage or greater aggressiveness to MON 87751 soybean, which would result in an invasive species. The insect resistance characteristic does not make the MON 87751 soybean a weed or invasive of natural habitats, since the reproductive and vegetative development characteristics of the soybean were not altered. The only advantage of soybeans MON 87751 is insect resistance. |
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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: |
The techniques that may be used for the detection of MON 87751 soybeans consist of: i) bioassays with the crop target pests showing the
Effectiveness provided by the Cry1A.105 and Cry2Ab2 proteins; Ii) PCR (Polymerase Chain Reaction) technique applied for the detection and identification of inserted DNA using primers specifically designed for these events. |
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
CTNBio
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| Authorization expiration date (a blank field means there is no expiration date) |
Not Applicable |
E-mail:
Organization/agency name (Full name): National Biosafety Technical Commission
Contact person name: Paulo Augusto Viana Barroso
Website:
Physical full address: SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number: 556120335087
Fax number:
Country introduction: Brazil had the first biosafety law approved in 1995. After the identification of the need to improve the biosafety system of Brazilian genetically modified organisms, a new law was published. The Law 11.105 / 05 establishes a technical committee dedicated to the analysis of the safety aspects of genetically modified organisms and a council of ministers that is dedicated to the analysis of the socioeconomic aspects of the commercial release of genetically modified organisms. In this context, Brazil already has several commercial products that involve genetically modified organisms (plants, human and veterinary vaccines, microorganisms for fuel production) and products derived from new genetic modification techniques. Useful links
Relevant documents
Stacked events: At the discretion of, and upon consultation with, CTNBio, a new analysis and issuance of technical opinion may be released on GMOs containing more than one event, combined through classic genetic improvement and which have been previously approved for commercial release by CTNBio Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Dr. Paulo Augusto Viana Barroso (President of national Biosafety Commission)
| Name of product applicant: |
Monsanto Canada Inc. |
| Summary of application: |
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| Date of authorization: |
31/10/2014 |
| 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
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| 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: |
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| 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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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: |
Compañia Agricola S.A.S |
| Summary of application: |
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| Date of authorization: |
06/02/2017 |
| 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.): |
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| 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: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
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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:
| Name of product applicant: |
Bayer West-Central Africa S.A. |
| Summary of application: |
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| Date of authorization: |
15/02/2024 |
| 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): |
The Board of the NBA considered the recommendations from the Technical Advisory Committee (TAC) following the Committee's thorough evaluation of the applications submitted by the applicant using information available on:
i. the Biosafety Clearing House (BCH), which is a mechanism set up by the Cartagena
Protocol on Biosafety to facilitate the exchange of information on Living Modified
Organisms (LMOs) and assist the Parties to better comply with their obligations under the Protocol and to which Ghana is a Party,
ii. the Organisation for Economic Co-operation and Development (OECD) Biotrack Product Database,
iii. the Food and Agriculture Organisation of the United Nations (FAO) genetically modified foods platform.
The following considerations were evaluated:
a. development of the modified events including the molecular biology data that characterizes the genetic change.
b. proximate analyses; major constituents (fats, proteins, carbohydrates) and minor
constituents (minerals and vitamins);
c. composition of, and nutritional information (including anti-nutrients) on the GM products compared to their conventional counterparts;
d. the potential for causing allergic reactions.
e. microbiological and chemical safety of the event(s);
f. the potential for production of new toxins in the event(s); and,
g. the potential for any unintended or secondary effects. |
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| Authorization expiration date (a blank field means there is no expiration date) |
3 years |
E-mail:
Organization/agency name (Full name): Ministry of Environment Science Technology and Inn
Contact person name: Eric Amaning Okoree
Website:
Physical full address: Ministries Accra
Phone number: 00233208163038
Fax number: 00233302688913/68866
Country introduction: The Ministry of Environment, Science, Technology and Innovation, is responsible for the regulation of all activities related to the management of the environment for the purpose of attaining sustainable development in line with the Millenium development goals. Consequently, the Ministry is responsible for the implementation of the Biosafety Law (Act 831) which came into force on 31 December 2011.
The Ministry imlemented the National Biosafety Authority in July 2015 to be responsible for all matters on rDNA-derived foods. The NBA receives, reviews and decides on all applications of this nature. Based on the type of application, the Act 831 constituted the Technical Advisory Committee to review the application and submit report to the Board of the NBA to make decision. Ghana has not yet carried out any rDNA-derived food safety assessment however, the NBA has approved confined field trials of rDNA-derived cotton, sweet potato, rice and cowpea. Currently, the National Biosafety Clearing House is undergoing maintenance, however the Ghana page on the Global Biosafety Clearing House has additional information that may be accessed through the following address: bch.cbd.int/about/countryprofile.shtml?country=gh Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: National Biosafety Authority, working with the Food and Drugs Authority as the Regulatory Agency for Food safety.
| Name of product applicant: |
Monsanto Indonesia (PT. Branita Sandhini) |
| Summary of application: |
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| Date of authorization: |
05/11/2018 |
| 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.): |
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| Summary of the safety assessment (food safety): |
Please refer to the link provided (in Indonesian) |
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| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
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E-mail:
Organization/agency name (Full name): Indonesian Agency for Agricultural Research and De
Contact person name: Sustiprijatno
Website:
Physical full address: BB Biogen Jl Tentara Pelajar 3A Bogor 16111 Indonesia
Phone number: +622518333440
Fax number: +622518334420
Country introduction:
- Indonesia has ratified Protocol on Biosafety to the Convention on Biological Diversity (CBD) through the Indonesian Law No. 21 / 2004. In the implementation, biosafety assessment for GM products, based on Goverment Regulation Number 21 /2005, Indonesia has regulated GM products on several items including : product kinds and requrements, research and developement, product importation, product assessment, release and distribution, supervision and monitoring, and institution and financing. We have also Law for food No. 18 /2012 which also consists of regulation for GM food.
- Indonesia already have procedure /application on GMO biosafety assessment and National Authorized Institution who conducting the biosafety assessment . Each GM food should have authorization from Goverment before it can be released and distributed. An application for authorisation for new GM food should be submited to Biosafety Commision through related Ministry or authorised Non Departement Goverment Agency (LPND) . Biosafety Commision, then sends the application to the National Agency for Drug and Food Control (Badan POM) for technical team to evaluate the GM food safety. The recommendation by technical team will be sent back to Biosafety Commision. The recommendation and GM Food safety certificate will be released by Biosafety Commision to the applicant through related ministry or LPND.
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: National Agency of Food and Drug Control (BPOM): http://www.pom.go.id/new/home/en
| Name of product applicant: |
Monsanto Company (USA) |
| Summary of application: |
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| Date of authorization: |
12/10/2016 |
| 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 links below. |
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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: |
Monsanto Malaysia Sdn. Bhd. |
| Summary of application: |
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| Date of authorization: |
15/03/2021 |
| 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.): |
Department of Biosafety Malaysia
CBD Biosafety Clearing House
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| 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: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
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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 Natural Resources, Environment and Climate Change
Level 4, Block F11, Complex F
Lebuh Perdana Timur, Precinct 1
62000 Putrajaya, Malaysia
Phone number: +60380917322
Fax number: +60380917371
Country introduction: GM food safety assessment is a requirement by law under the Biosafety Act 2007 in Malaysia. The National Biosafety Board reviews and makes decisions on events based on a scientific/technical risk assessment, policy considerations as well as public input. The decisions and its related documents made are publicly available through the Malaysian Department of Biosafety Website and the Convention of Biological Diversity Biosafety Clearing House. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Department of Biosafety, Ministry of Natural Resources, Environment and Climate Change Level 4, Block F11, Complex F Lebuh Perdana Timur, Precinct 1 62000 Putrajaya, Malaysia. 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]
| Name of product applicant: |
Monsanto Comercial, S. de R. L. de C.V. |
| Summary of application: |
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| Date of authorization: |
12/05/2016 |
| 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): |
No toxic, allergic or substantial nutritional changes were observed. Therefore it can be ensured that the Genetically Modified Soybean (Glycine max). OCDE identifier: MON-87751-7 is, based on the existing knowledge to date, as innocuous as its conventional counterpart. |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
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E-mail:
Organization/agency name (Full name): CIBIOGEM
Contact person name: Dra. Consuelo López López
Website:
Physical full address: San Borja #938, Col. Del Valle • Del. Benito Juárez C.P. 03100, México, D.F.
Phone number: +52 (55) 53227700
Fax number:
Country introduction: México ha buscado garantizar la inocuidad de los productos biotecnológicos para el uso y consumo de su población.
Desde 1984 el artículo 282 bis 1 de la Ley General de Salud, contempló que la Secretaría de Salud debería regular aquellos productos biotecnológicos, o sus derivados, destinados al uso o consumo humano.
En un inicio, con fundamento en este artículo, la Secretaria de Salud evaluó la inocuidad alimentaria de productos biotecnológicos, para su comercialización con fines de uso o consumo humano. A partir de 2005, con la entrada en vigor de la Ley de Bioseguridad de Organismos Genéticamente Modificados (LBOGM), se realizó la adecuación de la regulación para dar lugar a la Autorización que es el acto administrativo mediante el cual la Secretaría de Salud, a través de la Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), autoriza Organismos Genéticamente Modificados (OGMs), a efecto de que se pueda realizar su comercialización, así como su utilización con finalidades de Salud Pública o de Biorremediación.
Las facultades que corresponden a la Secretaría de Salud se estipulan en el artículo 16 de la LBOGM y lo relativo a la Autorizaciones se describe en los artículos 91 al 98 de dicha Ley.
Quienes pretendan obtener una Autorización para Comercialización e Importación de OGMs deben presentar ante COFEPRIS, una solicitud por escrito acompañada de la información a que se refiere los artículos 23 al 32 del Reglamento de la Ley de Bioseguridad de OGMs.
http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf
http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf
Courtesy translation
Mexico has sought to guarantee the safety of biotechnological products the use and consumption of its population. Since 1984, article 282 bis 1 from the General Law of Health, considered that the Secretary of Health should regulate those biotechnological products, or their derivatives, intended for food and feed use. Initially, the Secretary of Health evaluated the food safety of biotechnological products, based on this article, for commercialization with purposes of food, feed and processing. Subsequently in 2005, with the entry into force of the Law on Biosafety of Genetically Modified Organisms (LBOGM), the regulation was adapted to give rise to the Authorization, which is the administrative act through which the Secretary of Health, by means of the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), authorizes Genetically Modified Organisms (GMOs), to their commercialization, as well as their use for purposes of public health or bioremediation.
The faculties that correspond to the Secretary of Health are stipulated in Article 16 of the LBOGM and what is related to the Authorizations is described in Articles 91 to 98 of this Law. Those who seek to obtain an Authorization for GMOs merchandising and importation, must present to COFEPRIS, a written request accompanied by the information referred into articles 23 to 32 of the Regulation of the Law on Biosafety of Genetically Modified Organisms.
http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf
http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf 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: |
Monsanto Australia Ltd |
| Summary of application: |
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| Date of authorization: |
16/03/2016 |
| Scope of authorization: |
Food |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
OECD BioTrack Product Database
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| Summary of the safety assessment (food safety): |
In conducting a safety assessment of food derived from MON87751, a number of criteria
have been addressed including: a characterisation of the transferred gene sequences, their origin, function and stability in the soybean genome; the changes at the level of DNA and protein in the whole food; compositional analyses; and evaluation of intended and unintended changes.
No potential public health and safety concerns have been identified in the assessment of
insect-protected soybean line MON87751. On the basis of the data provided in the present Application, and other available information, food derived from MON87751 is considered to be as safe for human consumption as food derived from conventional soybean varieties. |
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A1110 – Food derived from Insect-protected Soybean Line MON87751
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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: |
MONSANTO |
| Summary of application: |
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| Date of authorization: |
08/11/2019 |
| 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): |
The food and feed safety assessment was performed following the CODEX Guidelines |
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Organization/agency name (Full name): Ministerio de Agricultura y Ganadería
Contact person name: Santiago Bertoni
Website:
Physical full address: Yegros 437 entre 25 de mayo y Cerro Cora
Phone number: +595 981 256262
Fax number:
Country introduction: The agricultural sector is one of the economic pillars of Paraguay in its contribution to the GDP, with the main crops being soybean, cassava, maize, wheat, sugar cane, and cotton. It should also be noted that Paraguay is the world’s fourth exporter of soybean. In 2020, the area planted with crops was 4.67 million hectares and consisted of soybean (3.56 million hectares), maize (1.08 million hectares), and cotton (18,000 hectares). Agricultural biotechnology was first regulated in Paraguay in 1997. In 2012, the system was adjusted through the creation of the National Agricultural and Forestry Biosafety Commission (CONBIO), “with the mission to manage, analyze, and issue recommendations on all matters related to the introduction, confined field trials, pre-commercial and commercial release, and other intended uses of GE crops” Almost 94% of the soybean, 36% of the maize, and 56% of the cotton planted in the country are GE. Useful links
Relevant documents
Stacked events: When a stacked event is approved, all possible combinations are approved. Previously evaluated single events are not reevaluated in stacks. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: In 2012, the system was adjusted through the creation of the National Agricultural and Forestry Biosafety Commission (CONBIO), “with the mission to manage, analyze, and issue recommendations on all matters related to the introduction, confined field trials, pre-commercial and commercial release, and other intended uses of GE crops”. Additional information https://conbio.mag.gov.py/
| Name of product applicant: |
Monsanto Philippines |
| Summary of application: |
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| Date of authorization: |
03/09/2018 |
| 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.): |
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| Summary of the safety assessment (food safety): |
A. STRP, PPSSD, BAI (Safety Assessment)
After thorough review of the technical documents submitted by the applicant, the assessors’ findings were as follows:
1. Host Organism (Soybean)
Soybean is a source of key nutrients such as proteins carbohydrates, fats, minerals (calcium, phosphorous, potassium, magnesium, iron, sodium, selenium, manganese, copper and zinc) and vitamins (A and B complex, K and E). In the human diet, soybean is consumed as food as soy milk, milk curd/tofu, whole cooked seed, edible soybean oil along with other vegetable oils, among others. On the other hand, soybean meal is a source of protein in animal diet.
Soybean also contains several antinutrients such as heat labile trypsin inhibitors, lectins, stachyose, raffinose and phytic acid. Trypsin inhibitors activities are destroyed during toasting or heating whole soybean or meal while lecithin is readily inactivated by moist heat when raw soybean is processed into defatted, toasted soybean meal. Soybean meal contains stachyose and raffinose that cause flatulence in swine and poultry. However, these are reduced or decreased by processing soybean further into concentrates or isolates. For phytic acid, adding phytase into the diets of poultry and swine will release phytinbond phosphorus that decreased phytic acid in the diet.
Further, soybean is not a source of toxicants. Although, soybean contains recognized allergenic protein, but relevant estimate of its allergenic potential is not complete. There is no significant level of amino acid homology exists between the pat gene and any protein allergens.
2. Donor Organism (Bacillus thuringensis)
The donor organism, Bacillus thuringensis is not known to be toxic or allergenic or pathogenic to humans, animals or plants. Bioinformatics analyses showed that the CryA.105 and Cry2Ab2 proteins do not share structurally or immunologically relevant amino acid sequence similarities with known allergens and pathogens.
Further, as shown in simulated digestion experiments using simulated digestive fluids, CryA.105 and Cry2Ab2 are rapidly digested. Thus, these cry proteins are not similar to known allergens and do not pose significant allergenic risk to humans or animals.
The molecular characterization of MON 87751 by Next Generation Sequencing and Junction Sequence Analysis (NGS/JSA) showed that a single copy of the intended transfer DNA (T-DNA I) containing the crylA.105 and the cry2Ab2 expression cassettes from PV-GMIR13196 was integrated into the soybean genome at a single locus. These analyses also showed no PV-GMIR13196 backbone or T-DNA II elements had been inserted.
3. The Transformation System
Soybean MON87751 was genetically modified using Agrobacterium tumefaciens -mediated transformation of soybean tissue using the transformation plasmid vector PV-GMIR13196.
The plasmid vector PV GMIR13196 contains two separate T DNAs that are each delineated by left and right border regions. The first T DNA, designated as T DNA I, contains the crylA.105 and cry2Ab2 expression cassettes. The second T DNA, designated as T DNA II, contains marker genes that allow for simplified selection of transformed tissue. During transformation, both T DNAs were inserted into the soybean genome. Subsequently, traditional breeding, segregation, selection and screening were used to isolate those plants that contain the crylA.105 and cry2Ab2 expression cassettes (T DNA I) and results showed it do not contain the marker gene expression cassettes (T DNA II), resulting in the production of marker-free, MON 87751.
4. The Inserted DNA
Using a combination of sequencing, PCR and bioinformatics, MON87751 demonstrated to contain one copy of the intended transfer DNA (T-DNA I) containing the cryIa.105 and the cry2Ab2 expression cassettes stably integrated at a single locus and inherited according to Mendelian principles over multiple generations.
The sequence and organization of the DNA insert is identical to the corresponding region in the PV GMIR13196 T DNA I. This was determined through directed sequencing (locus-specific PCR, DNA sequencing and analyses) on MON 87751 which established the complete sequence of the single DNA insert from PV GMIR13196, the adjacent flanking DNA, and the 5' and 3' insert-to-flank junctions. Further, this also confirmed that no vector backbone, or T-DNA II, or other unintended plasmid sequences are present in MON 87751.
5. Genetic Stability
The Next Generation Sequencing and Junction Sequence Analysis (NGS/JSA) showed the stability of the DNA insert across multiple generations. Thus, MON87751 contains a single and stable T-DNA I insertion.
Chi square test analysis was done and showed the stability of the insert over three generations (F2, F3 and F4).
The segregation analyses showed the heritability and stability of the insert as expected across multiple generations substantiating the molecular insert stability analysis and established the genetic behavior of the T-DNA I in MON 87751 at a single chromosomal locus.
6. Expressed Material
Using the enzyme-linked immunosorbent assay (ELISA), the expression levels of proteins Cry1A.105 and Cry2Ab2 in various MON 87751 plant tissues at different growth stages such as leaf, root, forage and seed were determined. The mean concentrations of each protein in leaves, roots, forage, and seeds were provided below.
Cry1A.105
The mean Cry1A.105 protein levels are: 400-790 ug/g dwt in leaves, 230 ug/g dwt in forage, 2.4 ug/g dwt in seeds, 11ug/g dwt in pollen/anther and below the limit of detection in roots.
Cry2Ab2
The mean Cry2Ab2 protein levels are: 24-32ug/g dwt in leaves, 14ug/g dwt in forage, 15ug/g dwt in seeds, 7.7ug/g dwt in pollen/anther and 15ug/g dwt in roots.
7. Toxicological Assessment
Digestibility
Digestibility of Cry1A.105 and Cry2Ab2 proteins was evaluated in Simulated Gastric Fluids (SGF) and Simulated Intestinal Fluids (SIF) and was analyzed through the sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE) and Western blot analysis.
Further, results showed that Cry1A.105 and Cry2Ab2 were rapidly digested at 0.5 minutes upon incubation in SGF with pepsin and in SIF with pancreatinin.
Heat Inactivation
Results of analyses showed that an increase in temperature did not affect the band intensity of Cry1A.105 and Cry2Ab2 proteins in SDS-PAGE. While the functional activity of Cry1A.105 and Cry2Ab2 proteins were decreased upon heat treatment at 75C and 55C, respectively for 15 and 30 minutes.
Amino Acid Comparison
Results of the FASTA bioinformatic alignment search showed that neither of the proteins (Cry1A.105 and Cry2Ab2) is homologous with known toxins.
Acute Oral Gavage
Cry1A.105 protein administered by oral gavage at a total dose of 2072 mg/kg body weight and Cry2Ab2 administered at a total dose of 2198 mg/kg body weight of CD-1 mice showed no treatment-related effects on survival, clinical observations, body weight gain, food consumption or gross pathology.
Source of Test Protein
The Cry1A.105 and Cry2Ab2 proteins were produced in Escherichia coli.
SDS-PAGE and Western blot analysis showed that the microbiologically-produced and the MON 87751 soybean expressed proteins were equivalent in terms of molecular weight and immune recognition.
Compositional Analysis (Nutritional Data)
Proximate Analysis
No statistically significant differences were observed in the proximate levels (moisture, protein, fat, ash, carbohydrates, acid detergent fiber (ADF) and neutral detergent fiber (NDF) between the test soybean and the control soybean.
Vitamins and Mineral Composition, Amino acids, Fatty Acids
A significant difference was observed in the levels of seven (7) nutrient components (protein, glycine, proline, phosphorus and vitamin E in seed and total fat and NDF in forage) out of the 50 components assessed for MON87751. However, the mean difference of these 7 components between MON87751 and control was less than the conventional control range value. Further, the MON 87751 mean component values were within the values observed in ILSI Crop Composition Database values.
Anti-nutrients
(lectin, trypsin inhibitors, phytic acid, raffinose and stachyose)
No significant differences were observed for lectin, trypsin inhibitors, phyticacid, and stachyose. A statistically significant difference (p<0.05) was observed for raffinose. The mean difference in raffinose values between MON 87751 and the conventional control was less than the range of the conventional control values, indicating that MON 87751 does not impact levels of raffinose more than natural variation within the conventional control grown at multiple locations.
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| Authorization expiration date (a blank field means there is no expiration date) |
September 4, 2023 |
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: |
Monsanto Korea Ltd. |
| Summary of application: |
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| Date of authorization: |
05/07/2017 |
| 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 see the link below(in Korean). |
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E-mail:
Organization/agency name (Full name): Ministry of Food and Drug Safety
Contact person name:
Website:
Physical full address: Osong Health Technology Administration Complex, 187, Osongsaengmyeong 2-ro, Osong-eup, Cheongwon-gun, Chungcheonbuk-do, 363-700, Korea
Phone number: 82-43-719-2360
Fax number:
Country introduction:
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
Monsanto |
| Summary of application: |
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| Date of authorization: |
08/05/2019 |
| 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): |
MON87751-7 has been modified to be protected against lepidopteran pests. Protection against these pests is achieved through expression of Cry1A.105 and Cry2Ab2, encoded by the cry1A.105 and cry 2Ab2 genes, respectively, derived from Bacillus thuringiensis. The Cry1A.105 protein is chimeric and comprises functional domains derived from the Cry1Ab, Cry1F and Cry1Ac proteins. The safety of the Cry1A.105 and Cry2Ab2 proteins has previously been assessed.
Molecular analyses showed that there is a single insertion site comprising a single, complete copy of each of the two expression cassettes. The introduced genetic elements are stably inherited from one generation to the next generation. There are no antibiotic resistance marker genes present in the line and no plasmid backbone has been incorporated into the transgenic locus.
Soybean MON87751-7 contains two newly expressed proteins, Cry1A.105 and Cry2Ab2, which are unlikely to be toxic or allergenic in humans.
Compositional analyses concluded that seeds from MON87751-7 are compositionally equivalent to seeds from conventional soybean varieties.
Based on the data provided in the present application, and other available information, food derived from MON87751-7 is considered to be as safe as food derived from conventional soybean varieties. |
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E-mail:
Organization/agency name (Full name): Singapore Food Agency (SFA)
Contact person name: Dr Tan Yong Quan
Website:
Physical full address: 52 Jurong Gateway Road 14-01 JEM Office Tower Singapore 608550
Phone number: (65)68052750
Fax number:
Country introduction: The Singapore Food Agency (SFA) is a Statutory Board established under the Ministry of Sustainability and the Environment (MSE) to oversee food safety and security. SFA’s mission is to ensure and secure a supply of safe food. SFA adopts a risk-based approach to food safety. Foods with foodborne hazards that may pose potential food safety risks to consumers are subjected to more stringent checks, regardless of their country of origin. SFA has in place an integrated system to ensure that both imported and domestically produced foods are safe for consumption. The system comprises control measures such as source accreditation, inspection and surveillance of food, laboratory analysis, food legislation and recall of food products, which safeguard food safety from farm to fork. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Singapore Food Agency (SFA)
| Name of product applicant: |
Monsanto Company |
| Summary of application: |
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| Date of authorization: |
27/04/2015 |
| 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.): |
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| Summary of the safety assessment (food safety): |
Please consult the website links below. |
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FDA's webpage regarding this variety
EPA Registered Plant Incorporated Protectants
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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
Fax number:
Country introduction: The United States is currently in the process of populating this database. The Food and Drug Administration regulates food and feed (food for humans and animals) from genetically engineered crops in conjunction with the Environmental Protection Agency (EPA). EPA regulates pesticides, including those that are plant incorporated protectants genetically engineered into food crops, to make sure that pesticide residues are safe for human and animal consumption and do not pose unreasonable risks of harm to human health or the environment. FDA In the Federal Register of May 29, 1992 (57 FR 22984), FDA published its "Statement of Policy: Foods Derived from New Plant Varieties" (the 1992 policy). The 1992 policy clarified the agency's interpretation of the application of the Federal Food, Drug, and Cosmetic Act with respect to human and animal foods derived from new plant varieties and provided guidance to industry on scientific and regulatory issues related to these foods. The 1992 policy applied to all foods derived from all new plant varieties, including varieties that are developed using genetic engineering (also known as recombinant deoxyribonucleic acid (rDNA) technology). In the 1992 policy, FDA recommended that developers consult with FDA about foods from genetically engineered plants under development and developers have routinely done so. In June 1996, FDA provided additional guidance to industry on procedures for these consultations (the consultation procedures). These procedures describe a process in which a developer who intends to commercialize food from a genetically engineered plant meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the genetically engineered food and then submits to FDA a summary of its scientific and regulatory assessment of the food. FDA evaluates the submission and if FDA has questions about the summary provided, it requests clarification from the developer. At the conclusion of the consultation FDA responds to the developer by letter. The approach to the safety assessment of genetically engineered food recommended by FDA during consultations, including data and information evaluated, is consistent with that described in the Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants. EPA The safe use of pesticidal substances is regulated by EPA. Food from a genetically engineered plant that is the subject of a consultation with FDA may contain an introduced pesticidal substance, also known as a plant-incorporated protectant (PIP), that is subject to food (food for humans and animals) safety and environmental review by EPA. PIPs are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. Both the PIP protein and its genetic material are regulated by EPA. When assessing the potential risks of PIPs, EPA requires studies examining numerous factors, such as risks to human health, non-target organisms and the environment, potential for gene flow, and insect resistance management plans, if needed. In regulating PIPs, decisions are based on scientific standards and input from academia, industry, other Federal agencies, and the public. Before the first PIP product was registered in 1995, EPA required that PIP products be thoroughly tested against human safety standards before they were used on human food and livestock feed crops. EPA scientists assessed a wide variety of potential effects associated with the use of PIPs, including toxicity, and allergenicity. These potential effects were evaluated in light of the public's potential exposures to these pesticides, taking into account all potential combined sources of the exposure (food, drinking water, etc.) to determine the likelihood that a person exposed at these levels would be predisposed to a health risk. Based on its reviews of the scientific studies and often peer reviews by the Federal Insecticide, Fungicide and Rodenticide Scientific Advisory Panel, EPA determined that these genetically engineered PIP products, when used in accordance with approved label directions and use restrictions, would not pose unreasonable risk to human health and the environment during their time-limited registration. Useful links
Relevant documents
Stacked events: Stacked events that are each plant incorporated protectants, as defined by the Environmental Protection Agency, must be registered by the Envriornmental Protection Agency before they can be commercialized. Food/feed safety asssessment of single events are generally sufficient to ensure the safety of food/feed from stacked events. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
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