[Federal Register Volume 74, Number 235 (Wednesday, December 9, 2009)]
[Notices]
[Pages 65088-65090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-29264]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2008-0094]
Pioneer Hi-Bred International, Inc.; Determination of
Nonregulated Status for Corn Genetically Engineered for Tolerance to
Glyphosate and Acetolactate Synthase-Inhibiting Herbicides
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public of our determination that a corn
line developed by Pioneer Hi-Bred International, designated as
transformation event 98140, which has been genetically engineered for
tolerance to glyphosate and acetolactate synthase-inhibiting
herbicides, 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 the Pioneer Hi-Bred International in its 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 its associated environmental assessment. This
notice also announces the availability of our written determination and
finding of no significant impact.
EFFECTIVE DATE: December 9, 2009.
ADDRESSES: You may read the petition, final environmental assessment,
determination, finding of no significant impact, comments we received
on our previous notice, and our responses to those comments in our
reading room. The reading room is located in room
[[Page 65089]]
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 these
documents on the Internet, go to (http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0094).
Other Information: Additional information about APHIS and its
programs is available on the Internet at (http://www.aphis.usda.gov).
FOR FURTHER INFORMATION CONTACT: Dr. Michael Watson, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-0846, email: [email protected]. To
obtain copies of the petition or the environmental assessment, contact
Mrs. Cindy Eck at (301) 734-0667, email: [email protected].
The petition and the environmental assessment are also available on the
Internet at (http://www.aphis.usda.gov/brs/aphisdocs/07_15201p.pdf)
and (http://www.aphis.usda.gov/brs/aphisdocs/07_15201p_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 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. Paragraphs (b) and (c) of Sec. 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 June 1, 2007, APHIS received a petition seeking a determination
of nonregulated status (APHIS Petition Number 07-152-01p) from Pioneer
Hi-Bred International, Inc., of Johnston, IA (Pioneer), for corn (Zea
mays L.) designated as transformation event 98140, which has been
genetically engineered for tolerance to glyphosate and acetolactate
synthase (ALS)-inhibiting herbicides, stating that corn line 98140 is
unlikely to pose a plant pest risk and, therefore, should not be a
regulated article under APHIS' regulations in 7 CFR part 340.
As described in the petition, the 98140 corn line has been
genetically engineered to express modified glyphosate acetyltransferase
(GAT4621) and modified maize acetolactate synthase (ZM-HRA) proteins.
The GAT4621 protein, encoded by the gat4621 gene, confers tolerance to
glyphosate-containing herbicides by acetylating glyphosate and thus
rendering it non-phytotoxic. The ZM-HRA protein, encoded by the zm-hra
gene, confers tolerance to the ALS-inhibiting class of herbicides
(e.g., sulfonylureas and imidazolinones). Expression of the zm-hra gene
is controlled by the maize ALS (acetolactate synthase) promoter. ALS is
the enzyme required for the production of essential branched-chain
amino acids such as valine, leucine, and isoleucine. The gat4621 gene
is based on the sequences of three gat genes from Bacillus
licheniformis, a common soil bacterium. Expression of the gat4621 gene
is driven by the corn ubiquitin promoter (ubiZM1). The zm-hra gene was
made by isolating the herbicide sensitive maize ALS gene and
introducing two specific changes known to confer herbicide tolerance to
tobacco ALS.
The genetic insert also contains the terminator sequence from
Solanum tuberosum (potato) and two sequences from two prevalent plant
pests, cauliflower mosaic virus (enhancer) and Agrobacterium
tumefaciens (border region). All of these sequences are well-
characterized and are non-coding regulatory regions only. Therefore,
these sequences will not cause the 98140 corn line to promote plant
disease.
A single copy of these genes and other DNA regulatory sequences
were introduced into the corn genome with the transformation vector
PHP24279 using disarmed (non-plant pest causing) A. tumefaciens
transformation of immature embryos. Plant cells containing the
introduced DNA were selected by culturing in the presence of
glyphosate. After the initial transformation, the antibiotic
carbenicillin was included in the culture medium to kill any remaining
Agrobacterium. Therefore, no part of the plant pest A. tumefaciens
remains in Pioneer HT corn due to the transformation method.
Pioneer's 98140 corn line has been considered a regulated article
under the regulations in 7 CFR part 340 because it contains gene
sequences from plant pathogens. The 98140 corn line has been field
tested in the United States since 2005 as authorized by APHIS
notifications and permits. In the process of reviewing the permits for
field trials of the subject corn, APHIS determined that the vectors and
other elements used to introduce the new genes 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. Field tests conducted under APHIS
regulatory oversight allowed for evaluation in a natural agricultural
setting while imposing measures to minimize the risk of persistence in
the environment after completion of the test. Data are gathered on
multiple parameters and used by the applicant to evaluate agronomic
characteristics and product performance. These field test data, in
turn, are used by APHIS to determine if the regulated corn event poses
a plant pest risk. Pioneer has petitioned APHIS to make a determination
that the 98140 corn line and the progeny derived from its crosses with
other nonregulated corn will no longer be considered regulated articles
under 7 CFR part 340.
In a notice\1\ published in the Federal Register on December 8,
2008 (73 FR 74453-74454, Docket No. APHIS-2008-0094), APHIS announced
the availability of Pioneer's petition and its associated draft
environmental assessment (EA) for public comment. APHIS solicited
comments on whether the subject corn would present a plant pest risk
and on the EA. APHIS received 31 unique comments during the comment
period. There were 12 comments from groups or individuals who supported
deregulation and 19 from those who opposed deregulation; attached to
one of these comments were 13,255 form letters (same letter, different
submitters). In addition, APHIS received a number of documents attached
to 12 blank comments. APHIS has addressed the issues raised during the
comment period and has provided responses to these comments as an
attachment to the finding of no significant impact.
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\1\ To view the notice, petition, EA, and the comments we
received, go to (http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0094).
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[[Page 65090]]
Determination
Based on APHIS' analysis of field, greenhouse, and laboratory data
submitted by Pioneer, references provided in the petition, information
described in the EA, comments provided by the public, and information
provided in APHIS' response to those public comments, APHIS has
determined that 98140 corn will not pose a plant pest risk and should
be granted nonregulated status for the following reasons: (1) Gene
introgression from Pioneer HT 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 varieties; (2) it exhibits no
characteristics that would cause it to be weedier than the non-
genetically engineered parent corn line or any other cultivated corn;
(3) horizontal gene transfer is unlikely to occur between Pioneer HT
corn and soil bacteria; (4) based on its lack of toxicity and
allergenicity, it does not pose a risk to non-target organisms,
including beneficial organisms and federally listed threatened or
endangered species, and species proposed for listing; (5) considering
its cultivation in the agroecosystem, it does not pose a risk to non-
target organisms, including threatened and endangered species, or
designated critical habitat as a result of the use of EPA-registered
glyphosate and ALS-inhibiting herbicides, as these have been safely
used in corn for many years; (6) it does not pose a threat to
biodiversity as it does not exhibit traits that increase its weediness,
its unconfined cultivation should not lead to increased weediness of
other cultivated corn, and it exhibits no changes in disease
susceptibility; (7) its commercial use should not have significant
effects on agricultural practices; (8) compared to current corn pest
and weed management practices, cultivation of Pioneer HT corn should
not impact standard agricultural practices in corn cultivation
including those for organic growers; (9) it should not cause
significant impacts on the development of herbicide resistant weeds or
cumulative impacts in combination with other herbicide tolerant crops;
(10) agronomic performance, disease and insect susceptibility, and
compositional profiles of Pioneer HT corn are similar to those of its
parent line and other corn cultivars grown in the United States,
therefore no direct or indirect plant pest effects on raw or processed
plant commodities are expected; (11) when considered in light of other
actions, APHIS identified no significant environmental impacts that
would result from a determination to grant nonregulated status to
Pioneer HT corn.
National Environmental Policy Act
To provide the public with documentation of APHIS' review and
analysis of any potential environmental impacts associated with the
determination of nonregulated status for 98140 corn, an EA was
prepared. 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,
the response to public comments, and other pertinent scientific data,
APHIS has reached a finding of no significant impact (FONSI) with
regard to the determination that Pioneer's 98140 corn line 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 in the ADDRESSES and FOR FURTHER INFORMATION CONTACT
sections of this notice.
Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7
CFR 2.22, 2.80, and 371.3.
Done in Washington, DC, this 3\rd\ day of December 2009.
Kevin Shea
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E9-29264 Filed 12-8-09: 8:45 am]
BILLING CODE: 3410-34-S