[Federal Register: November 1, 2004 (Volume 69, Number 210)]
[Notices]
[Page 63347-63349]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01no04-22]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 04-030-2]
Mycogen c/o Dow; Extension of Determination of Nonregulated
Status for Corn Genetically Engineered for Insect Resistance and
Glufosinate Herbicide Tolerance
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public of our decision to extend to one
additional corn line our determination that a corn line developed by
Mycogen Seeds c/o Dow AgroSciences LLC, which has been genetically
engineered for insect resistance and tolerance to the herbicide
glufosinate, is no longer considered a regulated article under our
regulations governing the introduction of certain genetically
engineered organisms. Our decision is based on our evaluation of data
submitted by Mycogen c/o Dow in its request for an extension of a
determination of nonregulated status, an analysis of other scientific
data, and a comment received from the public in response to a previous
notice. This notice also announces the availability of our written
determination and our finding of no significant impact.
[[Page 63348]]
EFFECTIVE DATE: October 20, 2004.
ADDRESSES: You may read the extension request, the environmental
assessment and finding of no significant impact, and the comment we
received on our previous notice 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.
APHIS documents published in the Federal Register, and related
information, including the names of organizations and individuals who
have commented on APHIS dockets, are available on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Ms. Robyn Rose, Biotechnology
Regulatory Services, APHIS, Suite 5B05, 4700 River Road Unit 147,
Riverdale, MD 20737-1236; (301) 734-0489. To obtain a copy of the
extension request or the environmental assessment and finding of no
significant impact, contact Ms. Terry Hampton at (301) 734-5715; e-
mail: Terry.A.Hampton@aphis.usda.gov. The extension request and the
environmental assessment and finding of no significant impact are also
available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/03_18101p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/03_18101p_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 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. Further, the regulations in Sec. 340.6(e)(2)
provide that a person may request that APHIS extend a determination of
nonregulated status to other organisms. Such a request must include
information to establish the similarity of the antecedent organism and
the regulated article in question.
Background
On June 30, 2003, APHIS received a request for an extension of a
determination of nonregulated status (APHIS No. 03-181-01p) from
Mycogen Seeds c/o Dow AgroSciences LLC (Mycogen/Dow) of Indianapolis,
IN, for corn (Zea mays L.) designated as maize line 6275 (corn line
6275), which has been genetically engineered for resistance to certain
lepidopteran pests and tolerance to the herbicide glufosinate. Mycogen/
Dow requested an extension of a determination of nonregulated status
issued in response to APHIS petition number 00-136-01p for insect
resistant and glufosinate tolerant corn line 1507, the antecedent
organism (see 66 FR 42624-42625, published August 14, 2001, Docket No.
00-070-3). Based on the similarity of corn line 6275 to the antecedent
corn line 1507, Mycogen/Dow requested a determination that corn line
6275 does not present a plant pest risk and, therefore, is not a
regulated article under APHIS' regulations in 7 CFR part 340.
On August 17, 2004, APHIS published a notice in the Federal
Register (69 FR 51058-51059, Docket No. 04-030-1) announcing that an
environmental assessment (EA) for the Mycogen/Dow extension request had
been prepared and was available for public comment. APHIS received one
comment on the subject EA during the designated 30-day public comment
period, which ended September 16, 2004. The comment, which was from a
private individual, stated, without reference to any supporting data,
that corn line 6275 should continue to be regulated because it is
harmful to humans and contains plant pathogens. APHIS evaluated the
safety of corn line 6275 in the EA and has provided a response to this
comment as an attachment to the finding of no significant impact
(FONSI). The EA and FONSI are available as indicated under FOR FURTHER
INFORMATION CONTACT.
Analysis
Like the antecedent organism, corn line 6275 has been genetically
engineered to express a Cry1F insecticidal protein derived from the
common soil bacterium Bacillus thuringiensis subsp. Aizawi (Bt aizawi).
The Cry1F protein is said to be effective in controlling certain
lepidopteran pests of corn, including European corn borer, black
cutworm, fall army worm, and southwestern corn borer. Corn line 6275
also contains the bar gene isolated from the bacterium Streptomyces
hygroscopicus. The bar gene encodes a phosphinothricin
acetyltransferase enzyme which confers tolerance to the herbicide
glufosinate. The antecedent organism contains the pat gene derived from
the bacterium Streptomyces viridochromogenes. The pat gene encodes a
phosphinothricin acetyltransferase (PAT) protein, which also confers
tolerance to glufosinate herbicides. Corn line 6275 was developed
through use of Agrobacterium-mediated transformation, while
microprojectile bombardment was used to transfer the added genes into
the antecedent organism, corn line 1507. The recipient line used in
both the antecedent organism and corn line 6275 was the public line
designated Hi-II.
Corn line 6275 expresses an insecticidal crystal protein identical
in amino acid sequence to the Cry1F protein expressed in line 1507,
both lines express an identical protein which confers tolerance to the
herbicide glufosinate, and the recipient line used in both lines was
the same public line Hi-II. Accordingly, we have determined that corn
line 6275 is similar to the antecedent organism in APHIS petition
number 00-136-01p and that corn line 6275 should no longer be regulated
under the regulations in 7 CFR part 340.
Corn line 6275 has been considered a regulated article under APHIS
regulations in 7 CFR part 340 because it contains gene sequences
derived from plant pathogens. However, corn line 6275 has been field
tested since 1999 under APHIS authorizations. In the process of
reviewing the notifications for field trials of the subject corn, APHIS
determined that the vectors and other elements were disarmed and that
the trials, which were conducted under conditions of reproductive and
physical confinement or isolation, would not present a risk of plant
pest introduction or dissemination.
Determination
Based on an analysis of the data submitted by Mycogen/Dow and a
review of other scientific data, APHIS has determined that corn line
6275: (1) Exhibits no plant pathogenic properties; (2) is no more
likely to become a weed than corn varieties developed by traditional
breeding techniques and is unlikely to increase the weediness potential
for any other cultivated or wild species with which it can interbreed;
(3) will not cause damage to raw or processed agricultural commodities;
(4) will not harm
[[Page 63349]]
threatened or endangered species or other organisms, such as bees, that
are beneficial to agriculture; and (5) is unlikely to have any
significant adverse impact on agricultural practices. Therefore, APHIS
has concluded that corn line 6275 and any progeny derived from crosses
with other corn varieties will be as safe to grow as corn that is not
subject to regulation under 7 CFR part 340.
Because APHIS has determined that the subject corn line does not
present a plant pest risk based on its similarity to the antecedent
organism, Mycogen/Dow corn line 6275 will no longer be 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 field testing, importation, or
interstate movement of the subject corn line or its progeny. However,
importation of corn line 6275 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
associated with the proposed extension of a determination of
nonregulated status for the subject corn line. 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 Mycogen/Dow corn line 6275
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
as indicated under FOR FURTHER INFORMATION CONTACT.
Done in Washington, DC, this 27th day of October 2004.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E4-2949 Filed 10-29-04; 8:45 am]
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