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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 articles

under APHIS' Biotechnology Regulations (Title 7 of Code of Federal Regulations (CFR), 

part 340). The requested extension was based on the 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 status 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 its 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 developed 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 Line 

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 

enzyme 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 hybrids derived from 

the same inbred parents used to develop HCEM485 and with the antecedent organism,

GA21 corn. Based on a comparative review of Stine Seed’s request to extend
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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 nongenetically engineered corn counterpart, as 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 diseases and pests; (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 traditional or other corn varieties; (3) HCEM485 exhibits 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 glyphosateresistant corn; (4) the 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 regarding 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 this determination of nonregulated status of HCEM485 is the 

most scientifically sound and appropriate regulatory decision.