A review of the environmental safety of the Cry1Ac protein.

This document provides a comprehensive review of information and data relevant to the environmental risk assessment of Cry1Ac and presents a summary statement about the environmental safety of this protein. All sources of information reviewed herein were publically available and included: dossiers presented to regulatory authorities; decision summaries prepared by regulatory authorities; peer reviewed literature; and product summaries prepared by product developers. Environmental risk assessments related to the introduction of genetically engineered (GE) plants are conducted on a case-by-case basis taking into account the biology of the plant, the nature of the transgene and the protein it produces, the phenotype conferred by the transgene as well as the intended use of the plant and the environment where it will be introduced (i.e., the receiving environment). These assessments are comparative by necessity, and typically involve comparisons to an untransformed parent line or closely related isoline (CBD, 2000a, 2000b; Codex, 2003a, 2003b; EFSA, 2006; NRC, 1989; OECD, 1992). The point of these comparisons is to identify potential risks the GE plant might present beyond what is already accepted for like plants in the environment. Any identified risks can then be assessed for likelihood and potential consequence. Regulatory approvals for environmental release of GE plants expressing Cry1Ac have been issued in eleven countries and include three species of plants (CERA, 2010; CFIA, 1997; CTNBio, 2005; Japan BCH, 1997, 1999, 2007; OGTR, 2002b, 2003a, 2003c, 2006a, 2006c; USDA APHIS, 1995, 1997a, 1997d, 2001, 2004) (Tab. 1). One event each for maize (Zea mays) and tomato (Lycopersicon esculentu) has received approval while 12 lines of cotton (Gossypium hirsutum) have received approval in at least one country. These regulatory reviews have generally considered the potential for Cry1Ac to adversely affect non-target organisms, the potential for Cry1Ac expression to affect the weediness potential of the modified plant, and the potential for gene flow to impact the weediness of wild relatives (CFIA, 1997; CTNBio, 2005; Japan BCH, 1997, 1999, 2007; OGTR, 2002b, 2003a, 2003c, 2006a, 2006c; USDA APHIS, 1995, 1997a, 1997d, 2001, 2004).