Return to Regulated Status of Alfalfa Genetically Engineered for Tolerance to the Herbicide Glyphosate
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: March 23, 2007 (Volume 72, Number 56)]
[Notices]
[Page 13735-13736]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23mr07-28]
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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.
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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.
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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
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