[Federal Register: August 12, 2005 (Volume 70, Number 155)]
[Notices]
[Page 47168-47169]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12au05-37]
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Notices
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.
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[[Page 47168]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 04-114-1]
Monsanto Company; Availability of Petition and Environmental
Assessment for Determination of Nonregulated Status for Corn
Genetically Engineered for Insect Resistance
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 Monsanto Company
seeking a determination of nonregulated status for corn designated as
transformation event MON 88017, which has been genetically engineered
for resistance to a corn rootworm complex and for tolerance to the
herbicide glyphosate. 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 public comments on whether this corn
presents 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 October
11, 2005.
ADDRESSES: You may submit comments by either of the following methods:
Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to Docket No. 04-114-1,
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your
comment refers to Docket No. 04-114-1.
EDOCKET: Go to http://www.epa.gov/feddocket to submit or
view public comments. Once you have entered EDOCKET, click on the
``View Open APHIS Dockets'' link to locate Docket No. 04-114-1.
Reading Room: You may read the petition, the environmental
assessment, and 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: You may view APHIS documents published in the
Federal Register and related information on the Internet at http://www.aphis.usda.gov/ppd/rad/webrepor.html
.
FOR FURTHER INFORMATION CONTACT: Dr. Robyn Rose, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-0489. To obtain copies of the petition or the
environmental assessment (EA), contact Ms. Ingrid Berlanger at (301)
734-4885; e-mail: ingrid.e.berlanger@aphis.usda.gov. The petition and
the EA are also available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/04_12501p.pdf and http://www.aphis.usda.gov/brs/
is.usda.gov/brs/
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. 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 May 4, 2004, APHIS received a petition (APHIS Petition Number
04-125-01p) from Monsanto Company (Monsanto) of St. Louis, MO,
requesting a determination of nonregulated status under 7 CFR part 340
for corn (Zea mays L.) designated as transformation event MON 88017
which has been genetically engineered for resistance to corn rootworm
and for tolerance to the herbicide glyphosate. The Monsanto petition
states that the subject corn should not be regulated by APHIS because
it does not present a plant pest risk.
As described in the petition, event MON 88017 corn has been
genetically engineered to express a Cry3Bb1 insecticidal protein
derived from Bacillus thuringiensis (Bt) subspecies kumamotoensis
strain EG4691. This gene has been modified to encode six specific amino
acid substitutions when compared to strain EG4691. Cry3Bb1 expression
is regulated by the enhanced 35S promoter (e35S) from cauliflower
mosaic virus, the rice actin intron (ract1 intron) 5' leader sequence
from wheat chlorophyll a/b-binding protein (wt CAB), and the 3'
nontranslated region of the 17.3 kDa heat shock protein from wheat.
Event MON 88017 has also been genetically engineered to express a 5-
enolpyruvylshikimate-3-phosphate synthase protein from Agrobacterium
sp. strain CP4 (CP4 EPSPS), which confers tolerance to the herbicide
glyphosate. Expression of cp4 epsps is regulated by the rice actin 1
(ract1) 5' untranslated region containing the promoter and first intron
and nopaline synthase 3' polyadenylation signal (NOS 3') from
Agrobacterium tumefaciens. A construct containing both genes was
delivered to the recipient corn variety, A xHi-II, through
Agrobacterium-mediated gene transfer. The petitioner states that the
Cry3Bb1 protein expressed in MON 88017 is 99.8 percent identical to the
Cry3Bb1 protein expressed in nonregulated corn line MON 863. The CP4
EPSPS protein is identical to corn line NK603.
[[Page 47169]]
Event MON 88017 has been considered a regulated article under the
regulations in 7 CFR part 340 because it contains gene sequences from
plant pathogens. This corn event has been field tested since 1999 in
the United States under APHIS notifications. 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.
In Sec. 403 of the Plant Protection Act (7 U.S.C. 7701-7772),
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 definition very broadly. The definition
covers direct or indirect injury, disease, or damage not just to
agricultural crops, but also to plants in general, for example, native
species, as well as to organisms that may be beneficial to plants, for
example, honeybees, rhizobia, etc.
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 by EPA regulation. In cases in
which genetically modified plants allow for a new use of a pesticide or
involve a different use pattern for the pesticide, EPA must approve the
new or different use. Accordingly, Monsanto submitted a request for
Section 3 Registration of Cry3Bb1 as a plant-incorporated protectant in
corn. On December 22, 2004, EPA announced the receipt of the
application on its Web site (http://www.epa.gov/pesticides/biopesticides/regtools/frnotices2004.htm
).
When the use of the pesticide on the genetically modified plant
would result in an increase in the residues in a food or feed crop for
which the pesticide is currently registered, or in new residues in a
crop for which the pesticide is not currently registered, establishment
of a new tolerance or a revision of the existing tolerance would be
required. Residue tolerances for pesticides are established by EPA
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended (21
U.S.C. 301 et seq.), and the Food and Drug Administration (FDA)
enforces tolerances set by EPA under the FFDCA. On March 31, 2004, EPA
granted a tolerance exemption for Cry3Bb1 (69 FR 16809-16814, March 31,
2004). The exemption concluded that there was a reasonable certainty of
no harm from consumption of the protein, as it is digestible in gastric
fluid and not considered an allergen.
FDA published a statement of policy on foods derived from new plant
varieties in the Federal Register on May 29, 1992 (57 FR 22984-23005).
The FDA statement of policy includes a discussion of FDA's authority
for ensuring food safety under the FFDCA, and provides guidance to
industry on the scientific considerations associated with the
development of foods derived from new plant varieties, including those
plants developed through the techniques of genetic engineering.
Monsanto has completed consultation with FDA on the subject corn event
(BNF No. 97, http://www.cfsan.fda.gov/lrd/biocon.html).
To provide the public with documentation of APHIS' review and
analysis of the environmental impacts and plant pest risk associated
with a proposed determination of nonregulated status for Monsanto's
event MON 88017 corn, an environmental assessment has been 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).
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 persons for a period of 60 days
from the date of this notice. We are also soliciting written comments
from interested persons on the environmental assessment prepared to
examine any environmental impacts of the proposed determination for the
subject corn event. The petition and the environmental assessment, and
any comments received are available for public review, and copies of
the petitions and the environmental assessment are available as
indicated in the FOR FURTHER INFORMATION CONTACT section of this
notice.
After the comment period closes, APHIS will review the data
submitted by the petitioner, all written comments received during the
comment period, and any other relevant information. After reviewing and
evaluating the comments on the petition and the environmental
assessment and other data and information, APHIS will furnish a
response to the petitioner, either approving the petition in whole or
in part, or denying the petition. APHIS will then publish a notice in
the Federal Register announcing the regulatory status of Monsanto's
insect-resistant corn event MON 88017 and the availability of APHIS'
written decision.
Authority: 7 U.S.C. 1622n and 7701-7772; 31 U.S.C. 9701; 7 CFR
2.22, 2.80, and 371.3.
Done in Washington, DC, this 8th day of August 2005 .
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E5-4384 Filed 8-11-E5; 8:45 am]
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