[Federal Register Volume 74, Number 235 (Wednesday, December 9, 2009)]
[Pages 65088-65090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-29264]



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.


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).



    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 
    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 
    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.

    \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).


[[Page 65090]]


    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 
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]