Mycogen Seeds/Dow AgroScience LLC and Pioneer Hi-Bred International Inc.; Availability of Petition and Environmental Assessment for Determination of Nonregulated Status for Genetically Engineered Corn, 38094-38096 [E5-3464]
Download as PDF
<![CDATA[
38094
Federal Register / Vol. 70, No. 126 / Friday, July 1, 2005 / Notices
Please state that your comment refers to
Docket No. 05–043–1.
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: You may view
APHIS documents published in the
Federal Register and related
information on the Internet at https://
www.aphis.usda.gov/ppd/rad/
webrepor.html.
FOR FURTHER INFORMATION CONTACT: For
information regarding regulations for
the interstate movement of animals
affected with Johne’s disease, contact
Dr. Michael Carter, Senior Staff
Veterinarian, Ruminant Health
Programs, National Center for Animal
Health Programs, VS, APHIS, 4700 River
Road Unit 46, Riverdale, MD 20737–
1231; (301) 734–4914. For copies of
more detailed information on the
information collection, contact Mrs.
Celeste Sickles, APHIS’ Information
Collection Coordinator, at (301) 734–
7477.
SUPPLEMENTARY INFORMATION:
Title: Johne’s Disease in Domestic
Animals; Interstate Movement.
OMB Number: 0579–0148.
Type of Request: Extension of
approval of an information collection.
Abstract: The Animal and Plant
Health Inspection Service (APHIS) of
the U.S. Department of Agriculture is
responsible for, among other things,
preventing the spread of serious
communicable animal diseases (such as
Johne’s disease) from one State to
another, and for eradicating such
diseases from the United States when
feasible.
Johne’s disease, also known as
paratuberculosis, is caused by
Mycobacterium paratuberculosis and
primarily affects cattle, sheep, goats,
and other domestic, exotic, and wild
ruminants. The disease is a chronic and
contagious enteritis that results in
progressive wasting and eventual death.
It is nearly always introduced into a
healthy herd by an infected animal that
is not showing symptoms of the disease.
The regulations in title 9, chapter I,
subchapter C of the Code of Federal
Regulations govern the interstate
movement of animals to prevent the
dissemination of livestock and poultry
diseases in the United States. Within
VerDate jul<14>2003
18:11 Jun 30, 2005
Jkt 205001
subchapter C, part 71 contains general
provisions for the interstate
transportation of animals, poultry, and
animal products, while part 80 pertains
specifically to the interstate movement
of domestic animals that are positive to
an official test for Johne’s disease.
Our regulations provide that cattle,
sheep, goats, and other domestic
animals that are positive to an official
test for Johne’s disease may generally be
moved interstate only to a recognized
slaughtering establishment or to an
approved livestock facility for sale to
such an establishment. The animals
must bear an official eartag and be
shipped with an owner-shipper
statement.
We are asking the Office of
Management and Budget (OMB) to
approve our use of these information
collection activities for an additional 3
years.
The purpose of this notice is to solicit
comments from the public (as well as
affected agencies) concerning this
information collection activity. These
comments will help us:
(1) Evaluate whether the information
collection is necessary for the proper
performance of our agency’s functions,
including whether the information will
have practical utility;
(2) Evaluate the accuracy of our
estimate of the burden of the
information collection, including the
validity of the methodology and
assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
information collection on those who are
to respond through use, as appropriate,
of automated, electronic, mechanical, or
other collection technologies, e.g.,
permitting electronic submission of
responses.
Estimate of burden: Public reporting
burden for this collection of information
is estimated to average 0.20 hours per
response.
Respondents: Herd owners, shippers,
and State representatives.
Estimated number of respondents:
250.
Estimated number of responses per
respondent: 1.
Estimated annual number of
responses: 250.
Estimated total annual burden on
respondents: 50 hours. (Due to
averaging, the total annual burden hours
may not equal the product of the annual
number of responses multiplied by the
reporting burden per response.)
All responses to this notice will be
summarized and included in the request
PO 00000
Frm 00005
Fmt 4703
Sfmt 4703
for OMB approval. All comments will
also become a matter of public record.
Done in Washington, DC, this 27th day of
June 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E5–3463 Filed 6–30–05; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. 04–113–1]
Mycogen Seeds/Dow AgroScience LLC
and Pioneer Hi-Bred International Inc.;
Availability of Petition and
Environmental Assessment for
Determination of Nonregulated Status
for Genetically Engineered Corn
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
SUMMARY: We are advising the public
that the Animal and Plant Health
Inspection Service has received a
petition from Mycogen Seeds/Dow
AgroScience LLC and Pioneer Hi-Bred
International Inc seeking a
determination of nonregulated status for
corn designated as corn line DAS–
59122–7, which has been genetically
engineered for resistance to a corn
rootworm complex and for tolerance to
the herbicide glufosinate. 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 August 30, 2005.
ADDRESSES: You may submit comments
by any of the following methods:
• Postal Mail/Commercial Delivery:
Please send four copies of your
comment (an original and three copies)
to Docket No. 04–113–1, 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. 04–113–1.
• EDOCKET: Go to https://
www.epa.gov/feddocket to submit or
view public comments, access the index
listing of the contents of the official
E:\FR\FM\01JYN1.SGM
01JYN1
Federal Register / Vol. 70, No. 126 / Friday, July 1, 2005 / Notices
public docket, and to access those
documents in the public docket that are
available electronically. Once you have
entered EDOCKET, click on the ‘‘View
Open APHIS Dockets’’ link to locate this
document.
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 https://
www.aphis.usda.gov/ppd/rad/
webrepor.html.
FOR FURTHER INFORMATION CONTACT: Dr.
Michael Watson, Biotechnology
Regulatory Services, APHIS, Suite 5B05,
4700 River Road Unit 147, Riverdale,
MD 20737–1236; (301) 734–0486; email:
michael.t.watson@aphis.usda.gov. 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: https://
www.aphis.usda.gov/brs/aphisdocs/
03_35301p.pdf and https://
www.aphis.usda.gov/brs/aphisdocs/
03_35301p_ea.pdf.
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 § 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 § 340.6
describe the form that a petition for a
determination of nonregulated status
VerDate jul<14>2003
18:11 Jun 30, 2005
Jkt 205001
must take and the information that must
be included in the petition.
On December 19, 2003, APHIS
received a petition (APHIS No. 03–353–
01p) from Mycogen Seeds/Dow
AgroSciences LLC of Indianapolis, IN,
and Pioneer Hi-Bred International of
Johnston, IA (Dow AgroSciences/
Pioneer), requesting a determination of
nonregulated status under 7 CFR part
340 for corn (Zea mays) designated as
corn line DAS–59122–7, which has been
genetically engineered for resistance to
corn rootworm and for tolerance to the
herbicide glufosinate. The
DowAgroSciences/Pioneer 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, corn line
DAS–59122–7 has been genetically
engineered to express a plant
incorporated protectant (PIP) that
controls certain corn rootworm. The PIP
is an insecticidal crystal protein (ICP)
from Bacillus thuringiensis strain
PS149B1. The ICP is made of two
proteins Cry34Ab1, approximately
14kDa, and Cry35Ab1, approximately 44
kDa in molecular weight. Transcription
of the Cry 34Ab1 coding sequence is
controlled by the maize ubiquitin
promoter (UBI1ZM PRO). Transcription
of Cry35Ab1 is controlled by a wheat
(Triticum aestivum) peroxidase (TA
Peroxidase) promoter. The termination
sequences for these two genes were
derived from the potato (Solanum
tuberosum) proteinase inhibitor II
(PINII). The PIP is expressed throughout
the plant and confers resistance to
northern corn rootworm (nCRW),
western corn rootworm (wCRW) and
Mexican corn rootworm (mCRW).
Corn line DAS–59122–7 has also been
genetically engineered to express the
enzyme phosphinothricin
acetyltransferase (PAT), which confers
tolerance to the herbicide glufosinate.
The expression of the pat gene, derived
from the bacterium Streptomyces
viridochromogenes, is under the control
of the cauliflower mosaic virus (CaMV)
35S RNA promoter and a CaMV
termination sequence (CaMV35S
TERM). The DAS–59122–7 corn line
was generated through Agrobacteriummediated transformation of the publicly
available corn line Hi–II.
Corn line DAS–59122–7 has been
considered regulated article under the
regulations in 7 CFR part 340 because it
contains gene sequences from a plant
pathogen. 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
PO 00000
Frm 00006
Fmt 4703
Sfmt 4703
38095
reproductive and physical confinement
or isolation, would not present a risk of
plant pest introduction or
dissemination.
In section 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,
DowAgroSciences/Pioneer has
submitted a request to EPA for Section
3 Registration of the Cry34/Cry35 ICP
construct as a plant incorporated
protectant in corn.
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. DowAgroSciences/
Pioneer has submitted a request to EPA
for a tolerance exemption for Cry34/
Cry35 ICP as expressed in the subject
corn events.
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,
E:\FR\FM\01JYN1.SGM
01JYN1
38096
Federal Register / Vol. 70, No. 126 / Friday, July 1, 2005 / Notices
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.
DowAgroSciences/Pioneer has
completed consultation with FDA on
the subject corn event (BNF No. 81,
https://www.cfsan.fda.gov/∼/rd/
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 the DowAgroSciences/Pioneer
corn line DAS–59122–7, an EA 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 § 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 EA prepared to examine
any environmental impacts of the
proposed determination for the subject
corn event. The petition and the EA and
any comments received are available for
public review, and copies of the petition
and the EA 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 EA
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 the
DowAgroSciences/Pioneer glyphosatetolerant corn line DAS–59122–7 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.
VerDate jul<14>2003
18:11 Jun 30, 2005
Jkt 205001
Done in Washington, DC, this 27th day of
June 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E5–3464 Filed 6–30–05; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Forest Service
Newspapers Used for Publication of
Legal Notice of Appealable Decisions
for the Northern Region; Northern
Idaho, Montana, North Dakota, and
portions of South Dakota and Eastern
Washington
Forest Service, USDA.
Notice.
AGENCY:
ACTION:
SUMMARY: This notice lists the
newspapers that will be used by all
Ranger Districts, Forests, Grasslands,
and the Regional Office of the Northern
Region to publish legal notices for
public comment and decisions subject
to appeal and predecisional
administrative review under 36 CFR
215, 217, and 218. The intended effect
of this action is to inform interested
members of the public which
newspapers will be used to publish
legal notices for public comment or
decisions; thereby allowing them to
receive constructive notice of a
decision, to provide clear evidence of
timely notice, and to achieve
consistency in administering the
appeals process.
DATES: Publication of legal notices in
the listed newspapers will begin with
decisions subject to appeal that are
made on or after July 1, 2005. The list
of newspapers will remain in effect
until another notice is published in the
Federal Register.
FOR FURTHER INFORMATION CONTACT:
Appeals and Litigation Group Leader;
Northern Region; P.O. Box 7669;
Missoula, Montana 59807. Phone: (406)
329–3696.
The newspapers to be used are as
follows:
Northern Regional Office
Regional Forester decisions in
Montana: The Missoulian, Great Falls
Tribune, and The Billings Gazette.
Regional Forester decisions in
Northern Idaho and Eastern
Washington: The Spokesman Review
and Lewiston Morning Tribune.
Regional Forester decisions in North
Dakota: Bismarck Tribune.
Regional Forester decisions in South
Dakota: Rapid City Journal.
PO 00000
Frm 00007
Fmt 4703
Sfmt 4703
Beaverhead/Deerlodge NF—Montana
Standard
Bitterroot NF—Ravalli Republic
Clearwater NF—Lewiston Morning
Tribune
Custer NF—Billings Gazette (Montana),
Rapid City Journal (South Dakota)
Dakota Prairie Grasslands—Bismarck
Tribune (North and South Dakota)
Flathead NF—Daily Inter Lake
Gallatin NF—Bozeman Chronicle
Helena NF—Independent Record
Idaho Panhandle NFs—Spokesman
Review
Kootenai NF—Daily Inter Lake
Lewis & Clark NF—Great Falls Tribune
Lolo NF—Missoulian
Nez Perce NF—Lewiston Morning
Tribune
Supplemental notices may be placed
in any newspaper, but time frames/
deadlines will be calculated based upon
notices in newspapers of record listed
above.
Dated: June 27, 2005.
Kathleen A. McAllister,
Deputy Regional Forester.
[FR Doc. 05–13012 Filed 6–30–05; 8:45 am]
BILLING CODE 3410–11–M
DEPARTMENT OF AGRICULTURE
Forest Service
Ashley National Forest, Utah; AshleyDry Fork Grazing Allotments
Forest Service, USDA.
Notice of intent to prepare an
environmental impact statement;
removal.
AGENCY:
ACTION:
SUMMARY: The Environmental Protection
Agency published in the Federal
Register of February 3, 2004, a notice of
intent to prepare an EIS for the AshleyDry Fork Grazing Allotments. This
document removes that notice of intent.
DATES: Effective on July 1, 2005.
FOR FURTHER INFORMATION CONTACT:
Dustin Bambrough, Interdisciplinary
Team Leader, Ashley National Forest,
355 N. Vernal Avenue, Vernal, UT
84078–789–1181.
SUPPLEMENTARY INFORMATION: The
Environmental Protection Agency
published in the Federal Register of
February 3, 2004 (DOCID:FR03fe04–42),
a notice of intent to prepare an EIS for
the Ashley-Dry Fork Grazing Allotments
to analyze a proposal to continue cattle
grazing on the Black Canyon, Lake
Mountain and Dry Fork Allotments
located on the Vernal Ranger District, in
Uintah County. This document removes
that notice of intent. The Forest Service
is not going to publish an environmental
impact statement.
E:\FR\FM\01JYN1.SGM
01JYN1
]]>Agencies
[Federal Register Volume 70, Number 126 (Friday, July 1, 2005)]
[Notices]
[Pages 38094-38096]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-3464]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 04-113-1]
Mycogen Seeds/Dow AgroScience LLC and Pioneer Hi-Bred
International Inc.; Availability of Petition and Environmental
Assessment for Determination of Nonregulated Status for Genetically
Engineered Corn
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has received a petition from Mycogen Seeds/Dow
AgroScience LLC and Pioneer Hi-Bred International Inc seeking a
determination of nonregulated status for corn designated as corn line
DAS-59122-7, which has been genetically engineered for resistance to a
corn rootworm complex and for tolerance to the herbicide glufosinate.
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 August 30,
2005.
ADDRESSES: You may submit comments by any of the following methods:
Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to Docket No. 04-113-1,
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. 04-113-1.
EDOCKET: Go to https://www.epa.gov/feddocket to submit or
view public comments, access the index listing of the contents of the
official
[[Page 38095]]
public docket, and to access those documents in the public docket that
are available electronically. Once you have entered EDOCKET, click on
the ``View Open APHIS Dockets'' link to locate this document.
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 https://
www.aphis.usda.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Dr. Michael Watson, Biotechnology
Regulatory Services, APHIS, Suite 5B05, 4700 River Road Unit 147,
Riverdale, MD 20737-1236; (301) 734-0486; email:
michael.t.watson@aphis.usda.gov. 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: https://
www.aphis.usda.gov/brs/aphisdocs/03_35301p.pdf and https://
www.aphis.usda.gov/brs/aphisdocs/03_35301p_ea.pdf.
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 December 19, 2003, APHIS received a petition (APHIS No. 03-353-
01p) from Mycogen Seeds/Dow AgroSciences LLC of Indianapolis, IN, and
Pioneer Hi-Bred International of Johnston, IA (Dow AgroSciences/
Pioneer), requesting a determination of nonregulated status under 7 CFR
part 340 for corn (Zea mays) designated as corn line DAS-59122-7, which
has been genetically engineered for resistance to corn rootworm and for
tolerance to the herbicide glufosinate. The DowAgroSciences/Pioneer
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, corn line DAS-59122-7 has been
genetically engineered to express a plant incorporated protectant (PIP)
that controls certain corn rootworm. The PIP is an insecticidal crystal
protein (ICP) from Bacillus thuringiensis strain PS149B1. The ICP is
made of two proteins Cry34Ab1, approximately 14kDa, and Cry35Ab1,
approximately 44 kDa in molecular weight. Transcription of the Cry
34Ab1 coding sequence is controlled by the maize ubiquitin promoter
(UBI1ZM PRO). Transcription of Cry35Ab1 is controlled by a wheat
(Triticum aestivum) peroxidase (TA Peroxidase) promoter. The
termination sequences for these two genes were derived from the potato
(Solanum tuberosum) proteinase inhibitor II (PINII). The PIP is
expressed throughout the plant and confers resistance to northern corn
rootworm (nCRW), western corn rootworm (wCRW) and Mexican corn rootworm
(mCRW).
Corn line DAS-59122-7 has also been genetically engineered to
express the enzyme phosphinothricin acetyltransferase (PAT), which
confers tolerance to the herbicide glufosinate. The expression of the
pat gene, derived from the bacterium Streptomyces viridochromogenes, is
under the control of the cauliflower mosaic virus (CaMV) 35S RNA
promoter and a CaMV termination sequence (CaMV35S TERM). The DAS-59122-
7 corn line was generated through Agrobacterium-mediated transformation
of the publicly available corn line Hi-II.
Corn line DAS-59122-7 has been considered regulated article under
the regulations in 7 CFR part 340 because it contains gene sequences
from a plant pathogen. 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 section 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, DowAgroSciences/Pioneer has
submitted a request to EPA for Section 3 Registration of the Cry34/
Cry35 ICP construct as a plant incorporated protectant in corn.
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. DowAgroSciences/Pioneer
has submitted a request to EPA for a tolerance exemption for Cry34/
Cry35 ICP as expressed in the subject corn events.
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,
[[Page 38096]]
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. DowAgroSciences/Pioneer has completed consultation
with FDA on the subject corn event (BNF No. 81, https://
www.cfsan.fda.gov//rd/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 the
DowAgroSciences/Pioneer corn line DAS-59122-7, an EA 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 EA prepared to examine any environmental
impacts of the proposed determination for the subject corn event. The
petition and the EA and any comments received are available for public
review, and copies of the petition and the EA 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 EA 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 the DowAgroSciences/Pioneer glyphosate-tolerant
corn line DAS-59122-7 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 27th day of June 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E5-3464 Filed 6-30-05; 8:45 am]
BILLING CODE 3410-34-P
