1 Extended Determination of Nonregulated Status for Maize ( Zea mays ) Line HCEM485

In response to a request to extend a determination of nonregulated status to include glyphosate

- resistant Maize Line HCEM485 ( APHIS # 09

- 063

- 01p ) from Stine Seed Farm, Inc. (hereafter referred to as Stine Seed ) received on April 1, 2011 , the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA) has determined that Maize Line HCEM485 and progeny derived from it are unlikely to pose plant pest risks and are no longer to be considered regulated article s under APHIS' Biotechnology Regulations (Title 7 of Code of Federal Regulations (CFR), part 340). Th e requested extension was based on t he similarity of Maize Line HCEM485 to another glyphosate

- resistant

, Roundup Ready® corn line

, GA21

, from Monsanto Company and Dekalb Genetics Corp. (hereafter referred to as Monsanto and Dekalb) for which APHIS issued a determination of nonregulated statu s on November 18, 1997 (APHIS petition # 97

- 099

- 01p). Since APHIS has determined that Maize Line HCEM485 is unlikely to pose a plant pest risk, APHIS will approve the request to extend the determination of nonregulated status to Maize Line HCEM485 and its progeny

. Therefore, APHIS

- approved permits or acknowledged notifications that were previously required for environmental release, interstate movement, or importation under those regulations will no longer be required for Maize Line HCEM485 and it s progeny

. Importation of Maize Line HCEM485 seeds and other propagative material would still be subject to APHIS foreign quarantine notices at 7 CFR part 319 and the Federal Seed Act regulations at 7 CFR part 201.

Both GA21 corn and Maize Line HCEM485 were develop e d using a direct DNA transfer method , i.e. without the use of plant pest vectors

, to insert into the corn genome a gene expression cassette that only confers glyphosate resistance. Monsanto and Dekalb developed the glyphosate

- resistant antecedent organism, transgenic GA21 corn by the insertion into the corn genome of a double

- mutated form of the corn ( Zea mays L.) 5

- enolpyruvylshikimate

- 3

- phosphate synthase ( EPSPS ) encoding gene containing optimized chloroplast transit sequences derived from Z. mays and Helianthus annus (sunflower) ribulose

- 1,5

- bisphosphate carboxylase genes under the control of regulatory sequences from both plant and bacterial sources ( i.e. a 5’ region of the rice ( Oryza sativa ) actin 1 gene containing the promoter and first intron and the 3’ nontranslated terminator region from the nopaline synthase ( nos ) gene derived from the Ti plasmid of the plant pest, Agrobacterium tumefaciens). Similarly, the glyphosate tolerance in Maize L ine HCEM485 is also based on expression of the same modified EPSPS enzyme derived from Z. mays
, but with the notable difference that expression of the modified EPSPS

en zyme is regulated by 5' promoter and 3' nontranslated terminator DNA sequences also derived from the Z. mays EPSPS

- encoding gene rather than regulatory sequences derived from other species

.

APHIS has conducted a Plant Pest Risk Assessment on glyphosate

- resistant Maize Line HCEM485 in comparison with nontransgenic counterpart control hybrid s derived from the same inbred parents u sed to develop HCEM485 and with the antecedent organism

, GA21 corn

. Based on a comparative review of Stine Seed’s request to extend2 nonregulated status to Maize Line HCEM485 ( 09

- 063

- 01p )

, APHIS concludes that HCEM485 is unlikely to pose a plant pest risk and should no longer be subject to the plant pest provisions of the Plant Protection Act and 7 CFR part 340 for the following reasons: (1) disease and insect susceptibility of HCEM485 is similar to that of its non

genetically engineered corn counterpart , a s it was with the antecedent organism ; and furthermore, there are no sequences derived from plant pests and no changes in agricultural practices are expected related to disease s and pest s ; (2) Like the antecedent organism, gene flow and introgression from Maize Line HCEM485 into wild relatives in the United States and its territories is unlikely to occur and genetic diversity of related plants is unlikely to be adversely affected any more so than might occur with cultivation of traditiona l or other corn varieties; (3) HCEM485 exhibit s no characteristics that would

cause it to be weedier or more difficult to control as a weed than non

- genetically engineered corn , the antecedent organism or other previously deregulated glyphosate

resistant c orn ; ( 4 ) th e similar composition of the transformed plant to other cultivated

corn and the expressed product of the inserted gene ( double

- mutated Z. mays EPSPS ) are common to the two events HCEM485 and GA21 corn and do not pose a risk to non

- target organisms, including beneficial organisms; ( 5 ) horizontal gene transfer between Maize Line HCEM485 and organisms with which it cannot interbreed is unlikely to occur. Similar to APHIS’ conclusions regarding plant pest risk in the determination of nonregulated status regarding GA21 corn , APHIS concludes that new varieties derived from Maize Line HCEM485 are unlikely to exhibit plant pest properties that are substantially different from the ones observed for other corn varieties not considered regulated articles under 7 CFR part 340.

Based on my review and consideration of all of the scientific and environmental data, analyses, information, and conclusions of the PPRA completed for HCEM485

, the previous conclusions re garding plant pest risk for the antecedent organism ( GA21 corn )

, the previous NEPA review completed for GA21 corn , and my knowledge and experience as the Deputy Administrator of APHIS Biotechnology Regulatory Services, I have determined and decided that th is determination of nonregulated status of HCEM485 is the most scientifically sound and appropriate regulatory decision.