Appendix B

Example of Data Submitted to Federal Agencies

The committee had the opportunity to review scientific studies that reflect the type of data submitted by Monsanto to EPA in support of registration for Bt Corn, Bollgard Cotton, and NatureMark NewLeaf Potato. The amount of data can be extensive (studies are typically 20 to 150 pages, single spaced, typed, 1” margins, 12 pt font), and as such, the committee did not have the time to thoroughly analyze all of the data provided. Although the specific studies may change depending on the transgenes and the plant species, the following list gives an indication of the type of data typically submitted for some transgenic pest-protected plants containing Bt transgenes.

Examples of Studies Submitted for Transgenic Pest-Protected Plants Containing Bt Transgenes
Corn

Molecular characterization of insect protected corn line MON 810.

Evaluation of insect-protected corn lines in 1994 U.S. field test locations.

Assessment of the equivalence of B.t.k HD-1 protein produced in several insect protected corn lines and Escherichia coli.

Compositional comparison of Bacillus thuringiensis subsp. kurstaki HD-1 protein produced in ECB resistant corn and the commercial microbial product, DIPEL.

Assessment of the equivalence of Bacillus thuringiensis subsp. kurstaki HD-1 protein produced in Escherichia coli and European corn borer resistant corn.

A dietary toxicity study with MON 80187 meal in the northern bobwhite.



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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION Appendix B Example of Data Submitted to Federal Agencies The committee had the opportunity to review scientific studies that reflect the type of data submitted by Monsanto to EPA in support of registration for Bt Corn, Bollgard Cotton, and NatureMark NewLeaf Potato. The amount of data can be extensive (studies are typically 20 to 150 pages, single spaced, typed, 1” margins, 12 pt font), and as such, the committee did not have the time to thoroughly analyze all of the data provided. Although the specific studies may change depending on the transgenes and the plant species, the following list gives an indication of the type of data typically submitted for some transgenic pest-protected plants containing Bt transgenes. Examples of Studies Submitted for Transgenic Pest-Protected Plants Containing Bt Transgenes Corn Molecular characterization of insect protected corn line MON 810. Evaluation of insect-protected corn lines in 1994 U.S. field test locations. Assessment of the equivalence of B.t.k HD-1 protein produced in several insect protected corn lines and Escherichia coli. Compositional comparison of Bacillus thuringiensis subsp. kurstaki HD-1 protein produced in ECB resistant corn and the commercial microbial product, DIPEL. Assessment of the equivalence of Bacillus thuringiensis subsp. kurstaki HD-1 protein produced in Escherichia coli and European corn borer resistant corn. A dietary toxicity study with MON 80187 meal in the northern bobwhite.

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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION Aerobic soil degradation of Bacillus thuringiensis var. kurstaki HD-1 protein. Acute oral toxicity study of Btk HD-1 tryptic core protein in albino mice. Assessment of the in vitro digestive fate of Bacillus thuringiensis subsp, kurstaki HD-1 protein. Stability of the Cry1A(b) insecticidal protein of B.t.k. HD-1 in sucrose and honey solutions under non-refrigerated temperature conditions. Evaluation of the dietary effects of purified B.t.k. endotoxin proteins on honey bee larvae. Evaluation of the dietary effects of purified B.t.k. endotoxin proteins on honey bee adults. Activated B.t.k. protein: a dietary toxicity study with green lacewing larvae. Activated B.t.k. protein: a dietary toxicity study with parasitic hymenoptera (Brachymeria intermedia). Activated B.t.k. protein: a dietary toxicity study with ladybird beetles. Evaluation of European corn borer resistant corn line MON 801 as a feed ingredient for catfish. Cry1A(b) insecticidal protein: an acute toxicity study with the earthworm in an artificial soil substrate. Effects of the Bacillus thuringiensis insecticidal proteins Cry1A(b), Cry1A(c), Cry3A on Folsomia candida and Xenylla grisea (Insecta: Collembola). Supplemental submission to MRID 43665502 on the expression of the Cry1A(b) protein in insect-protected line MON 810. Supplemental submission on the tissue expression and corn earworm (Helicoverpa zea) efficacy of the Cry1A(b) protein in insect-protected corn. Chronic exposure of Folsomia candida to corn tissue expressing Cry1A(b) protein. Corn pollen containing the Cry1A(b) protein: a 48-hour static-renewal test with Cladoceran (Daphnia magna). Cotton Determination of copy number and insert integrity for cotton line 531. Gene expression and compositional analysis from field-grown insect resistant cotton tissues. Assessment of equivalence between E. coli- produced and cotton–produced B.t.k. HD-73 protein and characterization of the cotton-produced B.t.k. HD-73 protein. Charcterization of purified B.t.k. HD-73 protein produced in Escherichia coli. Sensitivity of insect species to the purified Cry1Ac insecticdal protein from Bacillus thuringiensis var kurstaki (B.t.k. HD-73). Stability of the Cry1Ac insecticidal protein of Bacillus thuringiensis var kurstaki (B.t.k. HD-73) in sucrose and honey solutions under non-refrigerated temperature conditions. Evaluation of the dietary effect(s) of purified B.t.k. endotoxin proteins on honey bee larvae. Evaluation of the dietary effect(s) of purified B.t.k. endotoxin proteins on honey bee adults. B.t.k. HD-73 protein: A dietary toxicity study with parasitic hymenoptera (Nasonia vitripennis).

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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION B.t.k. HD-73 protein: A dietary toxicity study with ladybird beetles (Hippodamia convergens). B.t.k. HD-73 protein: A dietary toxicity study with green lacewing larvae (Chrysopa carnea). A dietary toxicity study with cotton seed meal in the northern bobwhite. B.t.k. HD-73 protein dose formulation and determination of dose for an acute mouse feeding study MD 92-493. Acute oral toxicity of Bacillus thuringiensis var. kurstaki (Cry1Ac) HD-73 protein in albino mice. Assessment of the in vitro digestive fate of Bacillus thuringiensis var kurstaki HD-73 protein. Aerobic soil degradation of Bacillus thuringiensis var kurstaki HD-73 protein bioactivity. Potato Molecular characterization of CPB resistant Russet Burbank Potatoes. Determination of the expression levels of B.t.t. and NPTII proteins in potato tissues derived from field grown plants. Equivalence of microbially-produced and plant-produced B.t.t. also called Colorado Potato Beetle active protein from B.t.t. Characterization of Colorado Potato Beetle active B.t.t protein produced in E. coli. Characterization of major tryptic fragment from Colorado Potato Beetle active protein from B.t.t. Compositional comparison of Colorado Potato Beetle active B.t.t. produced in Colorado Potato Beetle resistant potato plants and commercial microbial products. Sensitivity of selected insect species to the Colorado Potato Beetle active protein from B.t.t. Stability of Colorado Potato Beetle active B.t.t. protein in sucrose and honey solution under non-refrigerated temperature conditions. Evaluation of the dietary effect(s) of purified B.t.t. protein on honey bee larvae. Evaluation of the dietary effect(s) of purified B.t.t. protein on honey bee adults. B.t.t. protein: a dietary toxicity study with parasitic hymenoptera (Nassonia vitripennis). B.t.t. protein: a dietary toxicity study with ladybird beetles (Hippodamia convergens). B.t.t. protein: a dietary toxicity study with green lacewing larvae. B.t.t. protein: a dietary toxicity study with Russet Burbank potato in the northern bobwhite. Colroado potato beetle active B.t.t protein dose formulation, dose confirmation, and dose characterization for albino mice acute toxicity study (ML-92-407) Acute oral toxicity of B.t.t. protein in albino mice. Assessment of the metabolic degradation of the Colorado Potato Beetle active protein in simulated mammalian digestive models. Aerobic soil degradation of Colorado Potato Beetle active protein from B.t.t. Strategies for Colorado Potato Beetle Resistance Management in NewLeaf Potatoes.