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Monsanto NewLeaf potato regulations 

Monsanto NewLeaf potato which incorporate a Bt gene conferring resistance to Colorado Potato Beetle was first approved by the US regulatory agencies in early 1995. The GE Russet Burbank potato was first transformed and appeared in Canada food chain in 1996, Bt varieties of Atlantic and superior soon followed. In both cases, the potatoes were labeled as "NatureMark" and were accompanied by informational brochures detailing the new technology. In late 1998, Monsanto acqired final approval for a second type of GE potatoes: a Russet Burbank marketed as "NewLeaf Plus" which combines the Bt trait with resistance to the Potato Leaf Roll Virus (PLRV). Shortly after that, in 1999, Monsanto added a third GE potato "NewLeaf Y"  combining Bt with resistance to the Potato Virus Y (PVY). This GE trait was available in both Russet Burbank and Shepody varieties.


Regulatory decision documents 

NewLeaf Russet Burbank
Detailed Regulatory Information table

  Decision Document DD96-06: Determination of Environmental Safety of NatureMark Potatoes' Colorado Potato Beetle (CPB) Resistant Potato (Solanum  tuberosum L.)

  Novel Food Information - Food Biotechnology Colorado Potato Beetle Resistant Potato lines BT06, BT10, BT12, BT16, BT17, BT18, BT23

  FDA - Memorandum to file concerning insect-resistant potatoes.

  USDA-APHIS Environmental Assessment - Petition 94-257-01 for Determination of Nonregulated Status for Colorado Potato Beetle-Resistant Potato Lines BT6, BT10, BT12, BT16, BT17, BT18, AND BT23

  USDA-Plant Health Inspection Service - Monsanto Co. Petition for Determination of Nonregulated Status: Potatoes Producing the Colorado Potato Beetle Control Protein of Bacilllus thuringiensis subsp. tenebrionis


New Leaf Atlantic and Superior

Detailed Regulatory Information table

  Australia ? New Zealand food authority - Final risk assessment: application A382 - food derived from insect-protected potato lines BT-06, ATBT04-06, ATBT04-31, ATBT04-36, AND SPBT02-05

  Canadian Food Inspection Agency, Plant Biotechnology Office - Decision Document 97-20: Determination of the Safety of NatureMark Potatoes' Colorado Potato Beetle (CPB) Resistant Potato (Solanum tuberosum L.) Lines ATBT04-6, ATBT04-27, ATBT04-30, ATBT04-31 and ATBT04-36

  Office of Food Biotechnology, Health Canada - Novel food information - Colorado potato beetle resistant potato lines ATBT04-6, ATBT04-27, ATBT04-30, ATBT04-31, ATBT04-36, SPBT02-5, SPBT02-7

  FDA - Memorandum to file concerning the industry consultation on CPB resistant Atlantic and Superior potatoes

  USDA/APHIS Petition 95-338-01p for Determination of Nonregulated Status for Colorado Potato Beetle-Resistant Potato Lines SPBT02-5, SPBT02-7, ABTB04-6, ABTB04-27, ABTB04-30, ABTB04-31, ABTB04-36


NewLeaf Plus Russet Burbank

Detailed Regulatory Information table

  Australian ? New Zealand Food Authority - Draft risk assessment: A383 - food derived from insect and PLRV-protected potato lines RBMT21-129, RBMT21-350, RBMT22-082.

  Office of Food Biotechnology, Health Canada - Novel Food Information - Food Biotechnology Colorado Potato Beetle and Potato Leafroll Virus Resistant Potato lines RBMT21-129, RBMT21-350, RBMT22-082

  USDA ? APHIS - Monsanto Co. Application for an Extension of the Determination of Nonregulated Status for NewLeaf? Plus Potato Line RBMT22-82

  FDA - Memorandum to file concerning insect resistant and PLRV resistant potatoes.


NewLeaf Y

Detailed Regulatory Information table

  Australian ? New Zealand Food Authority - Draft risk analysis report: A384 - Food derived from insect and potato virus Y protected potato lines RBMT15-101, SEMT15-02, and SEMT15-15

  Office of Food Biotechnology, Health Canada - Novel Food Information - Food Biotechnology Colorado Potato Beetle and Potato Virus Y Resistant Potato lines SEMT15-02, SEMT15-15, RBMT15-101

  USDA ? APHIS - Monsanto Co. Petition for Determinaiton of Regulatory Status for NewLeaf? Y Potato Lines RBMT15-101, SEMT15-02, and SEMT15-15

  US Code of federal Regulation Notice Monsanto Co.; Availability of determination of nonregulated status for potato genetically engineered for insect and virus resistance.

  FDA - Memorandum to file concerning the industry consultation on CPB and PVY resistant potatoes

  USDA ? APHIS ? Environmental assessment-Monsanto Petition 97-339-01p for a Determination of Nonregulated Status for Transgenic Potato Lines Resistant to Colorado Potato Beetle and Potato Virus Y