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OECD Unique Identifier details

MON-87751-7
Commodity: Soyabean / Soybeans
Traits: Lepidoptera resistance
Australia
Name of product applicant: Monsanto Australia Ltd
Summary of application:

Monsanto Australia Limited submitted an application to FSANZ to vary the Australia New Zealand Food Standards Code (the Code) to include food from a new genetically modified (GM) soybean line with OECD Unique Identifier MON-87751-7 (referred to as MON87751). The soybean has been modified such that it is protected against lepidopteran pests including the key soybean pests bean shoot moth (Crocidosema aporema), sunflower looper (Rachiplusia nu) and fall armyworm (Spodoptera frugiperda).


 


Protection against these pests is achieved through expression of two Cry proteins (Cry1A.105 and Cry2Ab2) encoded by the cry1A.105 and cry 2Ab2 genes derived from the common soil bacterium 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 by FSANZ.


 


According to the Applicant, MON87751 will be combined, through traditional breeding, with other approved GM soybean lines (a process known as ‘stacking’) to provide additional protection against lepidopteran pests as well as tolerance to various herbicides. The product is designed primarily for commercial growing in South America (e.g. Brazil and Argentina) and approval for cultivation in Australia or New Zealand is not being sought. Therefore, if approved, food derived from this line may enter the Australian and New Zealand food supply as imported food products.


 


MON 87751 is intended for use as a broad-acre commodity (or field) soybean and not for vegetable, garden, or food-grade soybean that is generally used to produce food items such as tofu, soybean sprouts, soymilk, or green soybean (e.g. edamame). Vegetable and food-grade soybean generally have different characteristics (e.g. size, flavour, texture) from field soybean, and are more easily cooked.

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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
Summary of the safety assessment (food safety):
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: A1110 - Food derived from Insect-protected Soybean Line MON87751
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
janet.gorst@foodstandards.gov.au
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Janet Gorst
Website:
Physical full address:
Boeing Building, 55 Blackall Street, Barton ACT 2600, Australia
Phone number:
+61 2 6271 2266
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)

Australia
Name of product applicant: Monsanto Australia Ltd
Summary of application:

Monsanto Australia Limited submitted an application to FSANZ to vary the Australia New Zealand Food Standards Code (the Code) to include food from a new genetically modified (GM) soybean line with OECD Unique Identifier MON-87751-7 (referred to as MON87751). The soybean has been modified such that it is protected against lepidopteran pests including the key soybean pests bean shoot moth (Crocidosema aporema), sunflower looper (Rachiplusia nu) and fall armyworm (Spodoptera frugiperda).


 


Protection against these pests is achieved through expression of two Cry proteins (Cry1A.105 and Cry2Ab2) encoded by the cry1A.105 and cry 2Ab2 genes derived from the common soil bacterium 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 by FSANZ.


 


According to the Applicant, MON87751 will be combined, through traditional breeding, with other approved GM soybean lines (a process known as ‘stacking’) to provide additional protection against lepidopteran pests as well as tolerance to various herbicides. The product is designed primarily for commercial growing in South America (e.g. Brazil and Argentina) and approval for cultivation in Australia or New Zealand is not being sought. Therefore, if approved, food derived from this line may enter the Australian and New Zealand food supply as imported food products.


 


MON 87751 is intended for use as a broad-acre commodity (or field) soybean and not for vegetable, garden, or food-grade soybean that is generally used to produce food items such as tofu, soybean sprouts, soymilk, or green soybean (e.g. edamame). Vegetable and food-grade soybean generally have different characteristics (e.g. size, flavour, texture) from field soybean, and are more easily cooked.

Upload:
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
Summary of the safety assessment (food safety):
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: A1110 - Food derived from Insect-protected Soybean Line MON87751
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
janet.gorst@foodstandards.gov.au
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Janet Gorst
Website:
Physical full address:
Boeing Building, 55 Blackall Street, Barton ACT 2600, Australia
Phone number:
+61 2 6271 2266
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)

Brazil
Name of product applicant: Monsanto do Brasil Ltda.
Summary of application:
Commercial release of genetically modified soybeans Containing event MON87751 - Technical Report 5398/17
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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
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:
gutemberg.sousa@mctic.gov.br
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Edivaldo Domingues Velini
Website:
Physical full address:
SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number:
556134115516
Fax number:
556133177475
Country introduction:
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. Edivaldo Domingues Velini (President of national Biosafety Commission)

Canada
Name of product applicant: Monsanto Canada Inc.
Summary of application:

Monsanto has developed Insect Protected Soy – MON 87751 using recombinant DNA techniques to introduce two coding sequences: cry1A.105 and cry2Ab2, which encode the Cry1A.105 and Cry2Ab2 proteins, respectively. Both proteins are insecticidal ð-endotoxins that bind to specific cadherin receptors on the midgut epithelium of targeted lepidopteran insects. Both the cry1A.105 and cry2Ab2 coding sequences are derived from the common soil bacterium Bacillus thuringiensis, subspecies kurstaki.

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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
Summary of the safety assessment (food safety):
Please see decision document weblinks
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: 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:
Neil.Strand@hc-sc.gc.ca
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

New Zealand
Name of product applicant: Monsanto Australia Ltd
Summary of application:

Monsanto Australia Limited submitted an application to FSANZ to vary the Australia New Zealand Food Standards Code (the Code) to include food from a new genetically modified (GM) soybean line with OECD Unique Identifier MON-87751-7 (referred to as MON87751). The soybean has been modified such that it is protected against lepidopteran pests including the key soybean pests bean shoot moth (Crocidosema aporema), sunflower looper (Rachiplusia nu) and fall armyworm (Spodoptera frugiperda).


Protection against these pests is achieved through expression of two Cry proteins (Cry1A.105 and Cry2Ab2) encoded by the cry1A.105 and cry 2Ab2 genes derived from the common soil bacteriumBacillus 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 by FSANZ.


According to the Applicant, MON87751 will be combined, through traditional breeding, with other approved GM soybean lines (a process known as ‘stacking’) to provide additional protection against lepidopteran pests as well as tolerance to various herbicides. The product is designed primarily for commercial growing in South America (e.g. Brazil and Argentina) and approval for cultivation in Australia or New Zealand is not being sought. Therefore, if approved, food derived from this line may enter the Australian and New Zealand food supply as imported food products.


MON 87751 is intended for use as a broad-acre commodity (or field) soybean and not for vegetable, garden, or food-grade soybean that is generally used to produce food items such as tofu, soybean sprouts, soymilk, or green soybean (e.g. edamame). Vegetable and food-grade soybean generally have different characteristics (e.g. size, flavour, texture) from field soybean, and are more easily cooked.

Upload:
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
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.
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: A1110 – Food derived from Insect-protected Soybean Line MON87751
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
andrew.pearson@mpi.govt.nz
Organization/agency name (Full name):
Ministry for Primary Industries
Contact person name:
Andrew Pearson
Website:
Physical full address:
Pastoral House, 25 The Terrace, Wellington, 6012
Phone number:
+6448942535
Fax number:
Country introduction:

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

Useful links
Relevant documents
Stacked events:

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

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

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

United States of America
Name of product applicant: Monsanto Company
Summary of application:

Soybean
Trait 1 Added Protein or DNA: Cry1A.105
Source: Bacillus thuringiensis (B.t.) subsp. aizawai and B.t. subsp. kurstaki
Intended Effect: Resistance to Lepidopteran insects
Trait 2 Added Protein or DNA: Cry2Ab2
Source: Bacillus thuringiensis subsp. kurstaki
Intended Effect: Resistance to Lepidopteran insects
Event Designation: MON 87751

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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.):
Summary of the safety assessment (food safety):
Please consult the website links below.
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: FDA's webpage regarding this variety
EPA Registered Plant Incorporated Protectants
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
jason.dietz@fda.hhs.gov
Organization/agency name (Full name):
Food and Drug Administration
Contact person name:
Jason Dietz
Website:
Physical full address:
5100 Paint Branch Parkway, College Park MD 20740
Phone number:
240-402-2282
Fax number:
Country introduction:

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

Useful links
Relevant documents
Stacked events:

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

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

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