Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Notices 58663 

Total Burden Hours: 5. 

Charlene Parker, 

Departmental Information Collection 

Clearance Officer. 

[FR Doc. 05–20166 Filed 10–6–05; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. 04–113–2] 

Mycogen Seeds/Dow AgroSciences 

LLC and Pioneer Hi-Bred International 

Inc.; Availability of Determination of 

Nonregulated Status for Genetically 

Engineered Corn 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are advising the public of 

our determination that the Mycogen 

Seeds/Dow AgroSciences LLC and 

Pioneer Hi-Bred International Inc. corn 

designated as corn line DAS–59122–7, 

which has been genetically engineered 

for resistance to a corn rootworm 

complex and for tolerance to the 

herbicide glufosinate, is no longer 

considered a regulated article under our 

regulations governing the introduction 

of certain genetically engineered 

organisms. Our determination is based 

on our evaluation of data submitted by 

Mycogen Seeds/Dow AgroSciences LLC 

and Pioneer Hi-Bred International Inc. 

in their petition for a determination of 

non-regulated status, our analysis of 

other scientific data, and comments 

received from the public in response to 

a previous notice announcing the 

availability of the petition for 

nonregulated status and an 

environmental assessment. This notice 

also announces the availability of our 

written determination and our finding 

of no significant impact. 

DATE: Effective September 23, 2005. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Michael Watson, Biotechnology 

Regulatory Services, APHIS, 4700 River 

Road Unit 147, Riverdale, MD 20737–

1236; (301) 734–0486; e-mail: 

michael.t.watson@aphis.usda.gov. To 

obtain copies of the petition or, the 

determination, the environmental 

assessment (EA), or the finding of no 

significant impact (FONSI) contact Ms. 

Ingrid Berlanger at (301) 734–4885; email: ingrid.e.berlanger@aphis.usda.gov. 

The petition and the EA, including the 

FONSI and determination, are also 

available on the Internet at http:// 

www.aphis.usda.gov/brs/aphisdocs/ 

03_35301p.pdf and http:// 

www.aphis.usda.gov/brs/aphisdocs/ 

03_35301p_ea.pdf. 

SUPPLEMENTARY INFORMATION: The 

regulations in 7 CFR part 340, 

‘‘Introduction of Organisms and 

Products Altered or Produced Through 

Genetic Engineering Which Are Plant 

Pests or Which There Is Reason to 

Believe Are Plant Pests,’’ regulate, 

among other things, the introduction 

(importation, interstate movement, or 

release into the environment) of 

organisms and products altered or 

produced through genetic engineering 

that are plant pests or that there is 

reason to believe are plant pests. Such 

genetically engineered organisms and 

products are considered ‘‘regulated 

articles.’’

The regulations in § 340.6(a) provide 

that any person may submit a petition 

to the Animal and Plant Health 

Inspection Service (APHIS) seeking a 

determination that an article should not 

be regulated under 7 CFR part 340. 

Paragraphs (b) and (c) of § 340.6 

describe the form that a petition for a 

determination of nonregulated status 

must take and the information that must 

be included in the petition. 

On December 19, 2003, APHIS 

received a petition (APHIS No. 03–353–

01p) from Mycogen Seeds/Dow 

AgroSciences LLC of Indianapolis, IN, 

and Pioneer Hi-Bred International of 

Johnston, IA (Dow AgroSciences/ 

Pioneer), requesting a determination of 

nonregulated status under 7 CFR part 

340 for corn (Zea mays) designated as 

corn line DAS–59122–7, which has been 

genetically engineered for resistance to 

corn rootworm and for tolerance to the 

herbicide glufosinate. The Dow 

AgroSciences/Pioneer petition states 

that the subject corn should not be 

regulated by APHIS because it does not 

present a plant pest risk. 

In a notice published in the Federal 

Register on July 1, 2005 (70 FR 38094–

38096, Docket No. 04–113–1), APHIS 

announced the availability of the Dow 

AgroSciences/Pioneer petition and an 

environmental assessment (EA). APHIS 

solicited comments on whether the 

subject corn would present a plant pest 

risk and on the environmental 

assessment. The notice also discussed 

the role of APHIS, the Environmental 

Protection Agency, and the Food and 

Drug Administration in regulating the 

subject corn and products developed 

from it. 

APHIS received two comments by the 

close of the comment period on August 

30, 2005. One comment was from a 

trade association, which supported the 

petition. The other comment was from 

a private individual who did not 

support the petition. The response to 

these comments can be found in an 

attachment to the finding of no 

significant impact (FONSI). 

APHIS has amended the section of the 

EA titled ‘‘Potential impacts on 

threatened and endangered arthropods.’’

The amended section includes a 

reference to a process for assessment of 

impacts on threatened and endangered 

species that has been mutually agreed 

upon by the U.S. Fish and Wildlife 

Service and APHIS. The change in 

language merely provides clarity to the 

reader; it is not substantive and did not 

change the analysis described in the EA. 

As described in the petition, corn line 

DAS–59122–7 has been genetically 

engineered to express a plant 

incorporated protectant (PIP) that 

controls certain corn rootworm. The PIP 

is an insecticidal crystal protein (ICP) 

from Bacillus thuringiensis strain 

PS149B1. The ICP is made of two 

proteins Cry34Ab1, approximately 14 

kDa, and Cry35Ab1, approximately 44 

kDa in molecular weight. Transcription 

of the Cry34Ab1 coding sequence is 

controlled by the maize ubiquitin 

promoter (UBI1ZM PRO). Transcription 

of Cry35Ab1 is controlled by a wheat 

(Triticum aestivum) peroxidase (TA 

Peroxidase) promoter. The termination 

sequences for these two genes were 

derived from the potato (Solanum 

tuberosum) proteinase inhibitor II 

(PINII). The PIP is expressed throughout 

the plant and confers resistance to 

northern corn rootworm (nCRW), 

western corn rootworm (wCRW), and 

Mexican corn rootworm (mCRW). 

Corn line DAS–59122–7 has also been 

genetically engineered to express the 

enzyme phosphinothricin 

acetyltransferase (PAT), which confers 

tolerance to the herbicide glufosinate. 

The expression of the pat gene, derived 

from the bacterium Streptomyces 

viridochromogenes, is under the control 

of the cauliflower mosaic virus (CaMV) 

35S RNA promoter and a CaMV 

termination sequence (CaMV35S 

TERM). The DAS–59122–7 corn line 

was generated through Agrobacteriummediated transformation of the publicly 

available corn line Hi-II. 

Determination 

Based on its analysis of the data 

submitted by Dow AgroSciences/ 

Pioneer, a review of other scientific 

data, field tests of the subject corn, and 

the comments submitted by the public, 

APHIS has determined the following 

with respect to corn line DAS–59122–7: 

(1) It exhibits no plant pathogenic 

properties; although a plant pathogen 

was used in the development of this 

58664 Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Notices 

corn, these plants are not infected by 

this organism, nor do they contain 

genetic material from this pathogen that 

can cause plant disease; (2) it exhibits 

no characteristics that would cause it to 

be more weedy than the non-transgenic 

parent corn line or other cultivated 

corn; (3) gene introgression from DAS–

59122–7 corn into wild relatives in the 

United States and its territories is 

extremely unlikely and is not likely to 

increase the weediness potential of any 

resulting progeny nor adversely affect 

genetic diversity of related plants any 

more than would introgression from 

traditional corn hybrids; (4) disease and 

insect susceptibility and compositional 

profiles of the kernel is similar to nontransgenic corn and should have no 

adverse impact on raw or processed 

agricultural commodities; (5) it exhibits 

no potential to have significant adverse 

impact on organisms beneficial to 

agriculture; (6) compared to current 

agricultural practices, cultivation of 

DAS–59122–7 should not reduce the 

ability to control pests and weeds in 

corn or other crops. In addition to our 

finding of no plant pest risk, there will 

be no effect on threatened or 

endangered species resulting from a 

determination of non-regulated status 

for DAS–59122–7 and its progeny. 

Therefore, APHIS has concluded that 

the subject corn and any progeny 

derived from hybrid crosses with other 

non-transformed corn varieties will be 

as safe to grow as corn varieties in 

traditional breeding programs that are 

not subject to regulation under 7 CFR 

part 340. The effect of this 

determination is that Dow 

AgroSciences/Pioneer corn line DAS–

59122–7 is no longer considered a 

regulated article under APHIS’

regulations in 7 CFR part 340. 

Therefore, the requirements 

pertaining to regulated articles under 

those regulations no longer apply to the 

subject corn or its progeny. However, 

importation of corn line DAS–59122–7 

and seeds capable of propagation are 

still subject to the restrictions found in 

APHIS’ foreign quarantine notices in 7 

CFR part 319 and imported seed 

regulations in 7 CFR part 361. 

National Environmental Policy Act 

An EA was prepared to examine any 

potential environmental impacts and 

plant pest risk associated with the 

determination of nonregulated status for 

the Dow AgroSciences/Pioneer corn line 

DAS–59122–7. The EA was prepared in 

accordance with (1) The National 

Environmental Policy Act of 1969 

(NEPA), as amended (42 U.S.C. 4321 et 

seq.), (2) regulations of the Council on 

Environmental Quality for 

implementing the procedural provisions 

of NEPA (40 CFR parts 1500–1508), (3) 

USDA regulations implementing NEPA 

(7 CFR part 1b), and (4) APHIS’ NEPA 

Implementing Procedures (7 CFR part 

372). 

Based on that EA, APHIS has reached 

a FONSI with regard to the 

determination that Dow AgroSciences/ 

Pioneer corn line DAS–59122–7 and 

lines developed from it are no longer 

regulated articles under its regulations 

in 7 CFR part 340. Copies of the EA and 

FONSI are available from the individual 

listed in the FOR FURTHER INFORMATION

CONTACT section of this notice. 

Authority: 7 U.S.C. 1622n and 7701–7772; 

31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3. 

Done in Washington, DC, this 3rd day of 

October 2005. 

Elizabeth E. Gaston, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 05–20194 Filed 10–6–05; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. 05–062–2] 

University of Kentucky; Availability of 

an Environmental Assessment and a 

Finding of No Significant Impact for 

Field Tests of Genetically Engineered 

Neotyphodium 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are advising the public 

that the Animal and Plant Health 

Inspection Service has prepared an 

environmental assessment for a field 

trial of genetically engineered strains of 

an endophytic fungus of perennial 

ryegrass, Neotyphodium sp. isolate Lp1. 

The fungi have been genetically 

engineered to disrupt the ergovaline 

synthesis pathway. The environmental 

assessment provides a basis for our 

conclusion that these field tests will not 

present a risk of introducing or 

disseminating a plant pest and will not 

have a significant impact on the quality 

of the human environment. Based on its 

finding of no significant impact, the 

Animal and Plant Health Inspection 

Service has determined that an 

environmental impact statement need 

not be prepared for these field tests. 

DATES: A permit may be issued on or 

after October 7, 2005. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Michael Blanchette, Biotechnology 

Regulatory Services, APHIS, 4700 River 

Road, Unit 147, Riverdale, MD 20737–

1236; (301) 734–5141; e-mail: 

michael.p.blanchette@aphis.usda.gov. 

To obtain copies of the petition, the 

environmental assessment (EA), or the 

finding of no significant impact 

(FONSI), contact Ms. Ingrid Berlanger at 

(301) 734–4885; e-mail: 

ingrid.e.berlanger@aphis.usda.gov. The 

EA and FONSI are also available on the 

Internet at: http://www.aphis.usda.gov/ 

brs/aphisdocs/05_15201r_ea.pdf. 

SUPPLEMENTARY INFORMATION: The 

regulations in 7 CFR part 340, 

‘‘Introduction of Organisms and 

Products Altered or Produced Through 

Genetic Engineering Which Are Plant 

Pests or Which There Is Reason to 

Believe Are Plant Pests,’’ regulate, 

among other things, the introduction 

(importation, interstate movement, or 

release into the environment) of 

organisms and products altered or 

produced through genetic engineering 

that are plant pests or that there is 

reason to believe are plant pests. Such 

genetically engineered organisms and 

products are considered ‘‘regulated 

articles.’’ A permit must be obtained or 

a notification acknowledged before a 

regulated article may be introduced. The 

regulations set forth the permit 

application requirements and the 

notification procedures for the 

importation, interstate movement, or 

release into the environment of a 

regulated article. 

On June 1, 2005, the Animal and 

Plant Health Inspection Service (APHIS) 

received a permit application (APHIS 

No. 05–152–01r) from the University of 

Kentucky, Department of Plant 

Pathology, for a confined field release of 

two mutant strains of Neotyphodium sp 

isolate Lp1, which is an endophytic 

fungus of Lolium perenne (perennial 

ryegrass). These two mutants were 

generated by inserting a gene construct 

containing a hygromycin 

phosphotransferase gene (hph) into 

specific genes in the ergovaline 

synthesis pathway. The literature is 

obscure regarding the specific donor of 

the hph gene to the plasmid that was 

used to create this construct. The 

identical hph gene has been identified 

in three bacterial species, Klebsiella sp., 

Streptomyces hygroscopicus, and 

Escherichia coli. Expression of the hph 

gene is regulated by the Neurospora 

crassa cross-pathway control gene (cpc1) promoter and a transcription 

termination sequence from the trpC 

gene of Aspergillus nidulans. 

Strain Lp1–4175 results from an 

insertion of the hph construct in the 

dimethylallyltryptophan synthase