[Federal Register: January 6, 2006 (Volume 71, Number 4)]
[Notices]
[Page 906-908]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06ja06-17]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 04-114-2]
Monsanto Company; Availability of Determination of Nonregulated
Status for Corn Genetically Engineered for Insect Resistance and
Glyphosate Tolerance
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public of our determination that the
Monsanto corn line 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, 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 Monsanto
in their 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 an environmental assessment.
This notice also announces the availability of our written
determination and our finding of no significant impact.
DATES: Effective Date: December 14, 2005.
ADDRESSES: You may read the petition, the environmental assessment, the
determination, the finding of no significant impact, and the comments
that we received on Docket No. 04-114-1 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.
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, EA,
determination, FONSI, or response to comments, contact Ms. Ingrid
Berlanger at (301) 734-4885; e-mail: Ingrid.E.Berlanger@aphis.usda.gov.
The petition and the draft environmental
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assessment (EA) and the final EA with the determination, finding of no
significant impact, and response to comments are also available on the
Internet at: http://www.aphis.usda.gov/brs/aphisdocs/04_12501p.pdf,
http://www.aphis.usda.gov/brs/aphisdocs/04_12501p_pea.pdf, and http://www
.aphis.usda.gov/brs/aphisdocs2/04--12501p--com.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 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.
In a notice published in the Federal Register on August 12, 2005
(70 FR 47168-47169, Docket No. 04-114-1), APHIS announced the
availability of the Monsanto petition and an environmental assessment
(EA). APHIS solicited comments on whether the subject corn would
present a plant pest risk and on the EA. The August 2005 notice also
discussed the role of APHIS, the Environmental Protection Agency (EPA),
and the Food and Drug Administration (FDA) in regulating the subject
corn and products developed from it.
APHIS received 19 comments by the close of the 60-day comment
period, which ended on October 11, 2005. Comments were submitted by
university professionals, growers associations, and private
individuals. Eight comments supported granting nonregulated status to
corn line MON 88017. These comments cited corn rootworm as a
significant problem and supported the use of technologies to help
combat the problem. One commenter submitted a request to ``treat MON
88017 with suspicion until proven otherwise [safe],'' but provided no
basis for the concern and neither requested the petition be approved
nor denied. Ten comments were opposed to the action. Several of those
comments reflected a general disapproval of genetically engineered
crops. Several other comments cited the similarity of MON 88017 to MON
863 and cited an article that reviewed the acute toxicology studies
commissioned by European Food Safety Agency and did not address a
plant-pest risk. APHIS conferred with both FDA and EPA about the
results of that study. The response to these comments can be found in
an attachment to the finding of no significant impact (FONSI).
APHIS has amended the EA. A list of changes is included as an
attachment to the EA. The changes correct typographical errors and
provide clarity to the reader; these changes are not substantive and do
not change the analysis described in the EA.
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.
Determination
Based on its analysis of the data submitted by Monsanto, a review
of other scientific data, field tests of the subject corn, and the
comments submitted by the public, APHIS has determined that corn line
MON 88017 is no longer a regulated article under APHIS' regulations at
7 CFR part 340 for the following reasons: (1) It exhibits no plant
pathogenic properties (although a plant pathogen was used in the
development of this corn, these plants are not infected by this
organism, nor do they contain genetic material from this pathogen that
can cause plant disease); (2) it exhibits no characteristics that would
cause it to be weedier than the nontransgenic parent corn line or other
cultivated corn; (3) gene introgression from MON 88017 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 hybrids;
(4) disease and susceptibility and compositional profiles of the plants
of MON 88017 are similar to those of its parent variety and other corn
cultivars grown in the United States; therefore, no direct or indirect
plant pest effect on raw or processed plant commodities is expected;
(5) field observations, compositional analyses, and data on the safety
of the engineered EPSPS and Cry3Bb1 proteins all indicate that MON
88017 should not have greater potential than other cultivated corn to
damage or harm organisms beneficial to agriculture; (6) compared to
current corn pest and weed management practices, cultivation of MON
88017 should not reduce the ability to control pests and weeds in corn
or other crops. In addition to our finding of no plant pest risk, there
will be no effect on the threatened or endangered species resulting
from a determination of nonregulated status for MON 88017 and its
progeny.
Therefore, APHIS has concluded that the subject corn and any
progeny derived from hybrid crosses with other nontransformed corn
varieties will be as safe to grow as corn varieties in
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traditional breeding programs that are not subject to regulation under
7 CFR part 340. The effect of this determination is that Monsanto corn
line MON 88017 is no longer considered a regulated article under APHIS'
regulations in 7 CFR part 340.
Therefore, the requirements pertaining to regulated articles under
those regulations no longer apply to the subject corn or its progeny.
However, the importation of corn line MON 88017 and seeds capable of
propagation is still subject to the restrictions found in APHIS'
foreign quarantine notices in 7 CFR part 319 and imported seed
regulations in 7 CFR part 361.
National Environmental Policy Act
An EA was prepared to examine any potential environmental impacts
and plant pest risk associated with the determination of nonregulated
status for the Monsanto corn line MON 88017. 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, APHIS has reached a FONSI with regard to the
determination that Monsanto corn line MON 88017 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 from the individual
listed under FOR FURTHER INFORMATION CONTACT.
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 29th day of December, 2005.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 06-88 Filed 1-5-06; 8:45 am]
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