Record details

General information

Country submitting the decision or communication

United States of America

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

Record #6391

U.S. Department of Agriculture

USDA, APHIS, BRS
4700 River Road, Unit 133

Riverdale, MD

USA, 20737-1236

Email:	usbiotechregs@aphis.usda.gov
Url:	www.aphis.usda.gov

Record #6392

U.S. Food and Drug Administration

DHHS/FDA/CFSAN
5100 Paint Branch Parkway

College Park, MD

USA, 20740

Email:

biotechfood@fda.gov

Record #6413

U.S. Environmental Protection Agency

U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Code 7101
1200 Pennsylvania Ave, NW

Washington, DC

USA, 20460

Email:	biotech.reg@epa.gov
Url:	http://www.epa.gov/pesticides/biopesticides/,http://www.epa.gov/scipoly/oscpbiotech.htm,http://www.epa.gov/opptintr/biotech/

Title / Reference number of the decision or communication

Biotechnology Consultation Agency Response Letter BNF No. 000033

Date of the decision

1996-04-04

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

Yes

Jurisdiction

United States of America

Is this an amendment to a previous decision / communication?

Decision or communication details

Subject(s) of the decision

Decision on LMOs for direct use as food or feed, or for processing (Article 11, LMOs-FFPs)
- Decision on domestic use of an LMO, including its placing on the market

Uses of the LMO(s)

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?

Importer’s or Applicant’s contact details

Record #6943

Monsanto Company

Result of the decision

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

LMO identification

Record #14898

NMK-89279-1 - Atlantic NewLeaf™ potato

Resistance to antibiotics - Kanamycin Resistance to diseases and pests - Insects - Coleoptera (beetles)

Risk assessment

Record #114119

Biotechnology Consultation Note to the File BNF No. 000033

NMK-89761-6 - Atlantic NewLeaf™ potato
Resistance to antibiotics - Kanamycin
Resistance to diseases and pests - Insects - Coleoptera (beetles)
NMK-89367-8 - Atlantic NewLeaf™ potato
Resistance to antibiotics - Kanamycin
Resistance to diseases and pests - Insects - Coleoptera (beetles)
NMK-89613-2 - Atlantic NewLeaf™ potato
Resistance to antibiotics - Kanamycin
Resistance to diseases and pests - Insects - Coleoptera (beetles)
NMK-8917Ø-9 - Atlantic NewLeaf™ potato
Resistance to antibiotics - Kanamycin
Resistance to diseases and pests - Insects - Coleoptera (beetles)
NMK-89279-1 - Atlantic NewLeaf™ potato
Resistance to antibiotics - Kanamycin
Resistance to diseases and pests - Insects - Coleoptera (beetles)
NMK-89576-1 - Superior NewLeaf™ potato
Resistance to diseases and pests - Insects - Coleoptera (beetles)
NMK-89724-5 - Superior NewLeaf™ potato
Resistance to antibiotics - Kanamycin
Resistance to diseases and pests - Insects - Coleoptera (beetles)

Decision document

U.S. Food and Drug Administration