This regulation establishes an exemption from the requirement of a tolerance for residues of the Cry51Aa2.834_16 protein derived from Bacillus thuringiensis in or on cotton, when used as a plant- incorporated protectant. Monsanto Company submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting this exemption from the requirement of a tolerance. This regulation eliminates the need under FFDCA to establish a maximum permissible level for such residues.