Cotton seed is not generally consumed by humans due to the natural toxicants present in the seed. However food products primarily refined cotton seed oil containing highly processed and refined fractions of cottonseed are consumed.  Linters are an industrial by product of ginning, but some fractions are consumed as viscose, a highly processed food additive composed of nearly pure cellulose.  Analysis of refined cottonseed oil and processed cotton linters derived from conventional cotton and Cotton MON 88913 confirmed that there is no detectable protein in either cottonseed oil or processed cotton linters.
The margin of exposure (ratio of the no observed effect level (NOEL) derived from toxicological tests, to the estimate of human and animal dietary exposure) for the CP4 EPSPS protein from Cotton MON 88913 was calculated. The calculated margins indicate that there is no risk to human and animal health that will be associated with dietary exposure to food and feed products derived from MON 88913.
Significant human consumption of the CP4 EPSPS protein present in cotton is extremely unlikely. CP4 EPSPS protein represents approximately 0.12% of the total protein in cottonseed of MON 88913. Bioinformatics analysis was performed on the CP4 EPSPS protein sequence to assess the potential for similarity towards allergens, toxins or other pharmacologically active proteins.  The data demonstrate that the CP4 EPSPS is unlikely to share structurally relevant or immunologically relevance sequence similarities with known allergens. Data demonstrate that the CP4 EPSPS protein is highly unlikely to share any structural homology to any known toxins proteins. CP4 EPSPS do not present a risk of adverse biologically activity toward human and animals.
In the in vitro assessment, the CP4 EPSPS protein is rapidly degraded by gastric juices and therefore pose no significant toxicological hazards.  The enzymatic activity of CP4 EPSPS is destroyed after exposure at 65oC for 15 minutes.  Thus, novel proteins pose no significant toxicological hazard when subjected to those conditions which is common in cooking and other heat processing operations.
The amino acid profile of the novel protein exhibits no homology with known allergens or toxins and thus, maybe considered safe.
Results of compositional analyses (levels of key nutrients and other components) demonstrated that Cotton MON 88913 is comparable to the conventional counterparts.