Return to Regulated Status of Alfalfa Genetically Engineered for Tolerance to the Herbicide Glyphosate, 13735-13736 [E7-5344]
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13735
Notices
Federal Register
Vol. 72, No. 56
Friday, March 23, 2007
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.
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
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
sroberts on PROD1PC70 with NOTICES
AGENCY:
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:
VerDate Aug<31>2005
16:41 Mar 22, 2007
Jkt 211001
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
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Frm 00001
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\23MRN1.SGM
23MRN1
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
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
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 https://
www.regulations.gov, click on the
‘‘Advanced Search’’ tab, and select
‘‘Docket Search.’’ In the Docket ID field,
enter APHIS–2006–0157, then click
sroberts on PROD1PC70 with NOTICES
SUMMARY:
VerDate Aug<31>2005
16:41 Mar 22, 2007
Jkt 211001
‘‘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: https://
www.aphis.usda.gov/brs/aphisdocs/
04_36201p.pdf and https://
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.
PO 00000
Frm 00002
Fmt 4703
Sfmt 4703
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
E:\FR\FM\23MRN1.SGM
23MRN1
]]>Agencies
[Federal Register Volume 72, Number 56 (Friday, March 23, 2007)]
[Notices]
[Pages 13735-13736]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-5344]
========================================================================
Notices
Federal Register
________________________________________________________________________
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.
========================================================================
Federal Register / Vol. 72, No. 56 / Friday, March 23, 2007 /
Notices
[[Page 13735]]
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 Sec. 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.
[[Page 13736]]
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
