Biotechnology Consultation
Note to the File
BNF No. 000013

Subject: Monsanto's Bt-Resistant (Bollgard™) Cotton Lines 757 and 1076

Background

In a submission dated February 27, 1995, Monsanto provided summary information to support their safety assessment of cotton lines 757 and 1076. Based on this information, these cotton lines were developed using similar procedures and with the same intended technical effect as their cotton line 531. Because of the similarities between this submission and Monsanto's previous submission on their cotton line 531 dated November 21, 1994, this note to the file will only address topics that differ among these three cotton lines.

According to Monsanto, the inserted DNA is capable of expressing two proteins: 1) Bt-toxin; and 2) aminoglycoside 3'-phosphotransferase II (APH(3')II). Because the aad gene (3'(9)-O-aminoglycoside adenyltransferase) is under the control of a bacterial promoter, expression from this gene in cotton plants would not be anticipated. Monsanto reported that they confirmed that this gene is not expressed in their cotton lines 757 and 1076.

Because the safe use of Bt-toxins as pesticides is regulated by the Environmental Protection Agency (EPA) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and because EPA has exempted from the requirement of a tolerance residues of APH(3')II and the genetic material necessary for its production when used as a plant pesticide inert ingredient (59 FR 49351; September 28, 1994), this note to the file does not address the safe use of Bt-toxin as a pesticide or the use of APH(3')II⁽¹⁾ as a pesticide inert ingredient. Therefore, we limit our comments to the nutritional and toxicant properties of lines 757 and 1076.

Compositional Analysis

Based on the nature of the genetic modification, it is expected that cotton lines 757 and 1076 would not differ significantly in composition from other cotton varieties. To confirm this expectation, Monsanto analyzed the composition of cottonseed oil, and cottonseed meal obtained from lines 757, 1076, and a parental control lint.

Based on their analyses of line 531, Monsanto has concluded that cotton linters derived from their cotton lines 757 and 1076 are not materially different from cotton linters derived from other cotton varieties. They noted that the composition of linters is >99% cellulose; and because of the extensive processing prior to food use, fiber used for food is not expected to contain any detectable genetic material or protein.

Monsanto has concluded that cottonseed derived from their cotton lines 757 and 1076 is not materially different from cottonseed derived from other cotton varieties in their content of: protein, lipid, carbohydrate, ash, moisture, fatty acid profile, amino acid composition, or calories. Moreover, Monsanto has concluded that the levels of gossypol, aflatoxin, and cyclopropenoid fatty acids in cottonseed produced by lines 757 and 1076 are similar to levels observed in cottonseed produced by the parental line.

Monsanto has concluded that cottonseed oil derived from their cotton lines 757 and 1076 is not materially different from cottonseed oil derived from other cotton varieties in the content of fatty acids (14:0, 16:0, 16:1, 17:0, 18:0, 18:1, 18:2, 18:3, 20:0, and 22:0), as well as, several cyclopropenoid fatty acids (sterculic, dihydrosterculic, and malvalic), and alpha-tocopherol levels.

Finally, Monsanto has concluded that cottonseed meal derived from their cotton lines 757 and 1076 is not materially different from cottonseed meal derived from other cotton varieties.

Conclusions

Monsanto has concluded that their: "Bollgard Cotton Lines 757 and 1076 are not materially different from cotton varieties now being sold in any meaningful way except for the ability to resist feeding by lepidopteran insect pests." Moreover, Monsanto has concluded that: "Sales and consumption of cotton seed derived from this variety would be fully consistent with the Agency's Food Policy, the Federal Food, Drug, and Cosmetic Act, and current practices for the development and introduction of new cotton varieties. "

At this time, based on Monsanto's description of its data and analyses, the Agency considers Monsanto's consultation on their cotton lines 757 and 1076 to be complete.

/s/
Dennis M. Keefe, Ph.D.

⁽¹⁾FDA has approved the food additive use of the APH(3')II enzyme in the development of genetically modified cotton, oilseed rape, and tomatoes (59 FR 26700; May 23 1994)