[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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