Cotton seed oil and processed cotton linters are the only cotton products used for human consumption.  There is no detectable protein in cottonseed oil at a limit of detection for the assay of 1.3ppm total protein.  Analysis of processed linters also confirmed there was no detectable protein.All three DNA sequences leading to the expression of proteins (Cry1Ac, NPTII and AAD) are non pathogenic to humans and animals.  These proteins are also non allergenic and non toxic except for Cry1Ac, which is a delta-endotoxin crystal protein with toxicity.   The NPTII and AAD are enzymes involved in bacterial metabolism specifically modifies certain antibiotics such as kanamycin, spectinomycin and streptomycin and which do not have allergenic and toxic properties to humans and animals.  All donor organisms of the three proteins and the different DNA regulatory elements (promoters and terminators) were also non-pathogenic to humans and animals.  These regulatory elements are non-coding and therefore do not have the potential to encode proteins.  The strain of the E. coli used in Bollgard cotton event 531 is also non pathogenic and is ordinarily used in DNA cloning.There is a history of safe use of Cry1Ac protein in microbial Bt-based products. The amino acid sequence of the Cry1Ac protein expressed in Bollgard cotton has been predicted based on nucleotide sequence of the coding sequence The Cry1Ac protein produced in Bollgard cotton is >99.4% identical to the protein produced by the B. thuringiensis subsp kurstaki (B.t.k.) bacterial strain.  The NPTII protein expressed in Bollgard cotton is chemically and functionally similar to the naturally occurring NPTII protein. NPTII protein does not share any immunologicallly relevant sequence similarities to proteins considered as allergens or gliadins.  Both western blot analysis and enzymatic activity assays confirmed that NPTII readily degrade in simulated gastric and intestinal fluids. Results of these analyses demonstrate that seed from Bollgard cotton is compositionally equivalent to, and as nutritious as, seed from the parental cotton variety and other commercial cotton varieties.