[Federal Register Volume 73, Number 236 (Monday, December 8, 2008)]
[Notices]
[Pages 74453-74454]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-28968]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2008-0094]


Pioneer Hi-Bred International, Inc.; Availability of Petition and 
Environmental Assessment for 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 that the Animal and Plant Health 
Inspection Service has received a petition from Pioneer Hi-Bred 
International, Inc., seeking a determination of nonregulated status for 
corn designated as transformation event 98140, which has been 
genetically engineered for tolerance to glyphosate and acetolactate 
synthase-inhibiting herbicides. The petition has been submitted in 
accordance with our regulations concerning the introduction of certain 
genetically engineered organisms and products. In accordance with those 
regulations, we are soliciting comments on whether this genetically 
engineered corn is likely to pose a plant pest risk. We are also making 
available for public comment an environmental assessment for the 
proposed determination of nonregulated status.

DATES: We will consider all comments we receive on or before February 
6, 2009.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0094 to submit or view comments and 
to view supporting and related materials available electronically.
     Postal Mail/Commercial Delivery: Please send two copies of 
your comment to Docket No. APHIS-2008-0094, Regulatory Analysis and 
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, 
Riverdale, MD 20737-1238. Please state that your comment refers to 
Docket No. APHIS-2008-0094.
    Reading Room: You may read any comments that we receive on this 
docket 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.
    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. Natalia Weinsetel, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-0809, e-mail: [email protected]. 
To obtain copies of the petition or the draft environmental assessment, 
contact Ms. Cindy Eck at (301) 734-0667, e-mail: 
[email protected]. The petition and the draft 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

[[Page 74454]]

Agrobacterium. Therefore, no part of the plant pest A. tumefaciens 
remained 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.
    APHIS has prepared an environmental assessment (EA) in which it 
presents two alternatives for the determination of nonregulated status 
based on its analyses of data submitted by Pioneer, a review of other 
scientific data, and field tests conducted under APHIS oversight. APHIS 
is considering the following alternatives: (1) Take no action, i.e., 
APHIS would not change the regulatory status of the 98140 corn line and 
it would continue to be a regulated article, or (2) grant nonregulated 
status to corn line 98140 in whole.
    In section 403 of the Plant Protection Act (7 U.S.C. 7701 et seq.), 
``plant pest'' is defined as any living stage of any of the following 
that can directly or indirectly injure, cause damage to, or cause 
disease in any plant or plant product: A protozoan, a nonhuman animal, 
a parasitic plant, a bacterium, a fungus, a virus or viroid, an 
infectious agent or other pathogen, or any article similar to or allied 
with any of the foregoing. APHIS views this PPA definition to cover 
direct or indirect injury, disease, or damage not just to agricultural 
crops, but also to other plants, for example, native species, as well 
as to plant parts and plant products whether natural, manufactured, or 
processed.
    The 98140 corn line and any pesticides contained in or added to it 
are also subject to regulation by other Federal agencies. The U.S. 
Environmental Protection Agency (EPA) is responsible for the regulation 
of pesticides under the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA), as amended (7 U.S.C. 136 et seq.). FIFRA requires that all 
pesticides, including herbicides, be registered prior to distribution 
or sale, unless exempt from EPA regulation. In order to be registered 
as a pesticide under FIFRA, it must be demonstrated that when used with 
common practices, a pesticide will not cause unreasonable adverse 
effects in the environment. Under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), as amended (21 U.S.C. 301 et seq.), pesticides added to 
(or contained in) raw agricultural commodities generally are considered 
to be unsafe unless a tolerance or exemption from tolerance has been 
established. Residue tolerances for pesticides are established by EPA 
under the FFDCA, and the U.S. Food and Drug Administration (FDA) 
enforces the tolerances set by EPA. Pioneer submitted the appropriate 
regulatory package to EPA in 2007 to amend the corn tolerance for 
glyphosate to include the degradation by-product of glyphosate, N-
acetylglyphosate; the assessment is currently under review. Conditions 
for the safe use of glyphosate (EPA, 1993) and a number of ALS-
inhibiting herbicides (http://www.epa.gov/pesticides/reregistration/status.htm) have been established by the EPA through their registration 
of those pesticides for use on corn and the setting of tolerances.
    The FDA's policy statement concerning regulation of products 
derived from new plant varieties, including those genetically 
engineered, was published in the Federal Register on May 29, 1992 (57 
FR 22984-23005). Under this policy, FDA uses what is termed a 
consultation process to ensure that human and animal feed safety issues 
or other regulatory issues (e.g., labeling) are resolved prior to 
commercial distribution of a bioengineered food. In compliance with the 
FDA policy, Pioneer submitted a food and feed safety and nutritional 
assessment summary to FDA for their 98140 corn line in 2007; the 
assessment is currently under FDA review.

National Environmental Policy Act

    A draft EA has been prepared to inform the public of, and provide 
the APHIS decisionmaker with, a review and analysis of potential 
environmental impacts associated with the proposed determination of 
nonregulated status for the 98140 corn line. The draft 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).
    In accordance with Sec.  340.6(d) of the regulations, we are 
publishing this notice to inform the public that APHIS will accept 
written comments regarding the petition for a determination of 
nonregulated status from interested or affected persons for a period of 
60 days from the date of this notice. We are also soliciting written 
comments from interested or affected persons on the draft EA prepared 
to examine potential environmental impacts of the proposed 
determination for the deregulation of the subject corn line. The 
petition and the draft EA are available for public review, and copies 
of these documents are available as indicated under ADDRESSES and FOR 
FURTHER INFORMATION CONTACT above.
    After the comment period closes, APHIS will evaluate all written 
comments received during the comment period and any other relevant 
information. All public comments received regarding the petition and 
draft EA will be available for public review. After reviewing and 
evaluating the comments on the petition and the draft EA and other 
data, APHIS will furnish a response to the petitioner, either approving 
or denying the petition. APHIS will then publish a notice in the 
Federal Register announcing the regulatory status of Pioneer's 98104 
corn line and the availability of APHIS' written regulatory and 
environmental decision.

    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 2nd day of December 2008.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E8-28968 Filed 12-5-08; 8:45 am]
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