United States of America | BCH-DEC-US-48752 | Country's Decision or any other Communication

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Country's Decision or any other Communication (DEC)

BCH-DEC-US-48752-4 | PDF | Print |

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published: 13 May 2009 last updated: 17 Dec 2018

Amendment

Is this an amendment to a decision or communication already published on the BCH?

General Information

Country

United States of America

Competent National Authority(ies) responsible for the decision or communication

- Competent National Authority: | BCH-CNA-US-6391-2

Competent National Authority:

U.S. Department of Agriculture ()

USDA, APHIS, BRS 4700 River Road, Unit 133
Riverdale, MD
20737-1236, USA
Phone:

Fax:

Email: usbiotechregs@aphis.usda.gov,

Website: www.aphis.usda.gov,

BCH-CNA-US-6391-2
- Competent National Authority: | BCH-CNA-US-6392-2

Competent National Authority:

U.S. Food and Drug Administration ()

DHHS/FDA/CFSAN 5100 Paint Branch Parkway
College Park, MD
20740, USA
Phone:

Fax:

Email: biotechfood@fda.gov,

Website:

BCH-CNA-US-6392-2

Title / Reference number of the decision or communication

Biotechnology Consultation Agency Response Letter BNF No. 000087

Date of the decision

05 Oct 2005

Is the decision taken prior to entry into force of the Protocol?

Subject of the decision, notification, communication or declaration

Decision on LMOs for direct use as food or feed, or for processing (Article 11, LMOs-FFP)
Decision on LMOs for intentional introduction into the environment (according to Article 10 or domestic regulatory framework)

LMOs for intentional introduction into the environment

Was the decision triggered by a request for a transboundary movement of LMOs into your country?

Does the decision apply to transboundary movements of LMO(s) into the country?

Yes

Applicant’s contact details

- Organization: Monsanto Company () | BCH-CON-US-48751-1

Organization:

Monsanto Company ()

Phone:

Fax:

Email:

Website:

Does the decision involve commercial release?

Yes

Will the decision apply to subsequent introductions of the same LMO(s) into the environment?

Yes

LMOs for direct use as food or feed, or for processing (LMOs-FFP)

Use(s) of LMO

LMOs for direct use as food
LMOs for direct use as feed

Has the decision been taken in the absence of a domestic regulatory framework and in accordance with Article 11.6?

Result of the decision

Approval of the import and/or use of the LMO(s) without conditions

LMO identification & risk assessment

LMO identification

BCH-LMO-SCBD-15103-8 Living Modified Organism REN-ØØØ38-3 - Mavera™ maize

Changes in quality and/or metabolite content (Protein and amino acids)

Risk assessment

BCH-RA-US-114148-1 Risk Assessment generated by a regulatory process Biotechnology Consultation Note to the File BNF No. 000087

REN-ØØØ38-3 - Mavera™ maize | Maize, Corn, MAIZE, Changes in quality and/or metabolite content

Document on the decision, communication, notification or declaration

U.S. Food and Drug Administration [ English ]

BCH-DEC-US-48752-4 Report

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