This section of the FEDERAL REGISTER

contains documents other than rules or

proposed rules that are applicable to the

public. Notices of hearings and investigations,

committee meetings, agency decisions and

rulings, delegations of authority, filing of

petitions and applications and agency

statements of organization and functions are

examples of documents appearing in this

section.

Notices Federal Register

13735 

Vol. 72, No. 56 

Friday, March 23, 2007 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. 04–085–4] 

Return to Regulated Status of Alfalfa 

Genetically Engineered for Tolerance 

to the Herbicide Glyphosate 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are advising the public 

that the United States District Court for 

the Northern District of California has 

vacated the Animal and Plant Health 

Inspection Service’s (APHIS’) June 2005 

determination of nonregulated status 

with respect to the Monsanto Company 

and Forage Genetics International alfalfa 

lines designated as events J101 and 

J163, which have been genetically 

engineered for tolerance to the herbicide 

glyphosate. The effect of this action is 

that those alfalfa events, known as 

Roundup Ready alfalfa, are once again 

considered regulated articles under 

APHIS’ regulations in 7 CFR part 340 

and the requirements pertaining to 

regulated articles under those 

regulations will once again apply to the 

subject alfalfa and its progeny. This 

notice also advises Roundup Ready 

alfalfa sellers and growers that no 

Roundup Ready alfalfa seed may be 

planted after March 30, 2007; that only 

seed purchased by growers before 

March 12, 2007, may be planted by 

March 30, 2007; and that all sales of 

Roundup Ready alfalfa seed are 

prohibited pending the Court’s issuance 

of permanent injunctive relief. 

DATES: Effective Date: March 12, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Thomas Sim, Biotechnology Regulatory 

Services, APHIS, 4700 River Road Unit 

147, Riverdale, MD 20737–1236; (301) 

734–7324. 

SUPPLEMENTARY INFORMATION: 

Background 

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. 

On April 16, 2004, APHIS received a 

petition (APHIS petition number 04– 

110–01p) from Monsanto Company of 

St. Louis, MO, and Forage Genetics 

International of West Salem, WI 

(Monsanto/FGI), requesting a 

determination of nonregulated status 

under 7 CFR part 340 for alfalfa 

(Medicago sativa L.) designated as 

events J101 and J163, which have been 

genetically engineered for tolerance to 

the herbicide glyphosate. On November 

24, 2004, APHIS published a notice in 

the Federal Register (69 FR 68300– 

68301, Docket No. 04–085–1) 

announcing that the Monsanto/FGI 

petition and an environmental 

assessment were available for public 

review and soliciting comments for 60 

days ending January 24, 2005. In a 

second notice published February 3, 

2005, APHIS extended the comment 

period until February 17, 2005 (see 70 

FR 5601–5602, Docket No. 04–085–2). 

Subsequently, in a notice published in 

the Federal Register on June 27, 2005 

(70 FR 36917–36919, Docket No. 04– 

085–3), APHIS advised the public of its 

determination, effective June 14, 2005, 

that the Monsanto/FGI alfalfa events 

J101 and J163 were no longer 

considered regulated articles under our 

regulations governing the introduction 

of certain genetically engineered 

organisms. 

Recent Legal Decisions 

On February 13, 2007, the United 

States District Court for the Northern 

District of California issued a ruling in 

a lawsuit filed by the Center for Food 

Safety—along with several other 

nonprofit organizations and alfalfa 

growers—challenging APHIS’ decision 

to deregulate alfalfa events J101 and 

J163 (referred to in the lawsuit as 

Roundup Ready alfalfa). The lawsuit 

alleged violations of the National 

Environmental Policy Act (NEPA), the 

Endangered Species Act, and the Plant 

Protection Act. The court ruled that the 

deregulation may have significant 

environmental impacts that require the 

preparation of an environmental impact 

statement (EIS), and that APHIS violated 

NEPA by not preparing an EIS. 

Subsequently, on March 12, 2007, the 

court issued a preliminary injunction 

order in the case. As of March 12, 2007, 

all sales of Roundup Ready alfalfa seed 

are prohibited pending the Court’s 

issuance of permanent injunctive relief. 

The court decided that growers who 

have already planted Roundup Ready 

alfalfa will not be required to remove 

the plants. Additionally, they will be 

permitted to harvest, use, and sell such 

Roundup Ready alfalfa. The court also 

prohibited all future planting of 

Roundup Ready alfalfa beginning March 

30, 2007. Growers who intended to 

plant Roundup Ready alfalfa before that 

date and who had already purchased the 

seed prior to the March 12, 2007, 

preliminary injunction order may plant 

the seed. Growers who intended to plant 

alfalfa after March 30, 2007, or who did 

not purchase Roundup Ready alfalfa 

seed prior to March 12, 2007, must plant 

non-genetically engineered alfalfa. 

In addition, the court vacated APHIS’ 

June 2005 decision deregulating 

Roundup Ready alfalfa, and the plant 

line is once again a regulated article. In 

accordance with the court’s order, 

APHIS is issuing the appropriate notices 

informing Roundup Ready alfalfa sellers 

and growers of the terms of the court’s 

preliminary injunction order. The court 

has scheduled a hearing on a permanent 

injunction for April 27, 2007. 

By the terms of the court’s order, the 

Monsanto/FGI alfalfa lines that were the 

subject of APHIS’ June 2005 

determination of nonregulated status 

cited above are once again regulated 

articles under APHIS’ regulations in 7 

CFR part 340 and the requirements 

pertaining to regulated articles under 

those regulations will once again apply 

to the subject alfalfa and its progeny. 


sroberts on PROD1PC70 with NOTICES
13736 Federal Register / Vol. 72, No. 56 / Friday, March 23, 2007 / Notices 

Done in Washington, DC, this 19th day of 

March 2007. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E7–5344 Filed 3–22–07; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2006–0157] 

Syngenta Seeds, Inc.; Availability of 

Determination of Nonregulated Status 

for Corn Genetically Engineered for 

Insect Resistance 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are advising the public of 

our determination that a corn line 

developed by Syngenta, designated as 

transformation event MIR604, which 

has been genetically engineered for 

resistance to corn rootworm, 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 

Syngenta Seeds, Inc., in their petition 

for a determination of nonregulated 

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. 

DATES: Effective Date: March 16, 2007. 

ADDRESSES: You may read the petition, 

the environmental assessment, the 

determination, the finding of no 

significant impact, the comments we 

received on our previous notice, and our 

responses to those comments in our 

reading room. The reading room is 

located in room 1141 of the USDA 

South Building, 14th Street and 

Independence Avenue, SW., 

Washington, DC. Normal reading room 

hours are 8 a.m. to 4:30 p.m., Monday 

through Friday, except holidays. To be 

sure someone is there to help you, 

please call (202) 690–2817 before 

coming. To view those documents on 

the Internet, go to http:// 

www.regulations.gov, click on the 

‘‘Advanced Search’’ tab, and select 

‘‘Docket Search.’’ In the Docket ID field, 

enter APHIS–2006–0157, then click 

‘‘Submit.’’ Clicking on the Docket ID 

link in the search results page will 

produce a list of all documents in the 

docket. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Catherine Preston, Biotechnology 

Regulatory Services, APHIS, 4700 River 

Road Unit 147, Riverdale, MD 20737–

1236; (301) 734–5874. To obtain copies 

of the petition or the environmental 

assessment (EA) and finding of no 

significant impact (FONSI), contact Ms. 

Cynthia Eck at (301) 734–0667, e-mail: 

cynthia.a.eck@aphis.usda.gov. The 

petition, EA, and FONSI are also 

available on the Internet at: http:// 

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

04_36201p.pdf and http:// 

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

04_36201p_ea.pdf. 

SUPPLEMENTARY INFORMATION: 

Background 

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 24, 2004, APHIS 

received a petition (APHIS No. 04–362–

01p) from Syngenta Seeds, Inc. 

(Syngenta) of Research Triangle Park, 

NC, requesting a determination of 

nonregulated status under 7 CFR part 

340 for corn (Zea mays L.) designated as 

transformation event MIR604, which 

has been genetically engineered for 

resistance to corn rootworm (CRW). In 

response to APHIS’ subsequent requests 

for additional information and 

clarification, Syngenta submitted a 

revised final petition on August 2, 2006. 

The Syngenta petition states that the 

subject corn should not be regulated by 

APHIS because it does not present a 

plant pest risk. 

Analysis 

As described in the petition, corn 

transformation event MIR604 has been 

genetically engineered to express two 

transgenes: (1) The modified cry3A 

(mcry3A) gene derived from a wellcharacterized gene sequence from 

Bacillus thuringiensis, encoding the 

mCRY3A insect control protein and (2) 

the pmi (manA) gene from Escherichia 

coli, which encodes the enzyme 

phosphomannose isomerase (PMI) for 

use as a selectable marker. Expression of 

the mcry3A gene by corn plants renders 

the corn line resistant to CRW. 

Regulatory elements for the mcry3A and 

pmi genes were derived from maize and 

Agrobacterium tumefaciens. These 

regulatory sequences are not transcribed 

and do not encode proteins. The DNA 

was introduced into corn cells using 

Agrobacterium-mediated transformation 

methodology with the T–DNA 

transformation vector designated 

pZM26. In addition to transgenes 

necessary for insertion into the plant 

genome, the T–DNA vector also 

contained two additional genetic 

elements: (1) A gene conferring bacterial 

resistance to the antibiotics 

erythromycin, streptomycin, and 

spectinomycin and (2) the bacterial 

origin of replication. Plant cells 

containing the introduced DNA were 

then selected by culturing in the 

presence of mannose. After the initial 

incubation with Agrobacterium, the 

broad-spectrum antibiotic cefotaxime 

was included in the culture medium to 

kill any remaining Agrobacterium. 

In a notice published in the Federal 

Register on January 10, 2007 (72 FR 

1212–1214, Docket No. APHIS–2006–

0157), APHIS announced the 

availability of the Syngenta petition and 

an environmental assessment (EA). 

APHIS solicited comments on whether 

the subject corn would present a plant 

pest risk for 60 days ending on March 

12, 2007, and on the EA for 30 days 

ending on February 9, 2007. In order to 

provide interested persons additional 

time to prepare and submit comments 

on the draft EA, APHIS extended the 

comment period for the EA until March 

9, 2007, i.e., the date 15 days after the 

publication of our notice of extension. 

APHIS received 14 comments on the EA 

and 27 comments on the petition by the 

close of their respective comment 

periods. There were 20 comments 

submitted in support of the petition to 

grant nonregulated status to MIR604 

corn and 7 that were opposed. With 

regard to the EA prepared by APHIS to 

examine the potential environmental 

impacts of granting nonregulated status 

to MIR604 corn, there were seven 


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