[Federal
Register: March 9, 2004 (Volume 69, Number 46)]
[Notices]
[Page 10972-10973]
From the Federal Register Online via GPO Access
[wais.access.gpo.gov]
[DOCID:fr09mr04-24]
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.
[[Page 10972]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 04-010-1]
Mycogen c/o Dow; Availability of Petitions and Environmental
Assessment for Determinations of Nonregulated Status for Cotton
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 two petitions from Mycogen Seeds
c/o Dow AgroSciences LLC seeking determinations of nonregulated
status for cotton lines designated as Cry1F cotton event
281-24-236 and Cry1Ac cotton event 3006-210-23, which have been
genetically engineered for insect resistance. The petitions have
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 these cotton lines present a plant pest risk. We are
also making available for public comment an environmental
assessment for the proposed determinations of nonregulated
status.
DATES: We will consider all comments we receive on or before May
10, 2004.
ADDRESSES: You may submit comments by any of the following
methods:
<BULLET Postal Mail/Commercial Delivery: Please send four
copies of your comment (an original and three copies) to Docket
No. 04-010-1, 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.
04-010-1.
<BULLET E-mail: Address your comment to
regulations@aphis.usda.gov. Your comment must be contained
in the body of your message; do not send attached files. Please
include your name and address in your message and ``Docket No.
04-010-1'' on the subject line.
<BULLET Agency Web Site: Go to
http://www.aphis.usda.gov/ppd/rad/cominst.html for a form
you can use to submit an e-mail comment through the APHIS Web
site.
<BULLET Federal eRulemaking Portal: Go to
http://www.regulations.gov
and follow the instructions for locating this docket and
submitting comments.
Reading Room: You may read the petitions, 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,
including the names of groups and individuals who have commented
on APHIS dockets, on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Dr. Susan Koehler,
Biotechnology Regulatory Services, APHIS, Suite 5B05, 4700 River
Road Unit 147, Riverdale, MD 20737-1236; (301) 734-4886. To
obtain copies of the
petitions or the environmental assessment, contact Ms. Kay
Peterson at (301) 734-4885; e-mail:
Kay.Peterson@aphis.usda.gov. The petitions are also
available on the Internet at
http://www.aphis.usda.gov/brs/aphisdocs/03_03601p.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 February 5, 2003, APHIS received two petitions from
Mycogen Seeds c/o Dow AgroSciences LLC (Mycogen/Dow) of
Indianapolis, IN, requesting determinations of nonregulated
status under 7 CFR part 340 for cotton (Gossypium hirsutum L.)
designated as Cry1F cotton event 281-24-236 (cotton event Cry1F)
(APHIS Petition No. 03-036-01p) and Cry1Ac cotton event
3006-210-23 (cotton event Cry1Ac) (APHIS Petition No.
03-036-02p), which have been genetically engineered for
resistance to certain lepidopteran insect pests. The Mycogen/Dow
petitions state that the subject cotton events should not be
regulated by APHIS because they do not present a plant pest
risk.
As described in the petitions, cotton events Cry1F and
Cry1Ac have been genetically engineered to express synthetic
insecticidal proteins derived from the common soil bacterium
Bacillus thuringiensis (Bt). The petitioner states that the
Cry1F and Cry1Ac proteins are effective in providing protection
from the feeding of lepidopteran insect pests such as tobacco
budworm, beet armyworm, soybean looper, and cotton bollworm.
The subject cotton events also express the pat gene derived from
Streptomyces viridochromogenes, a non-pathogenic bacterium. The
pat gene encodes the enzyme phosphinothricin acetyltransferase
(PAT), which confers tolerance to glufosinate herbicides and is
present in cotton events Cry1F and Cry1Ac as a selectable
marker. The subject cotton events were developed through use of
the Agrobacterium-mediated
transformation method.
[[Page 10973]]
Cotton events Cry1F and Cry1Ac were developed primarily so that
they could be crossed to produce a cotton line which contains
both the insecticidal proteins and thereby to maintain a range
of effective
control options for lepidopteran insect pests and to reduce the
potential for the development of resistance to Bt insecticides.
Cotton events Cry1F and Cry1Ac have been considered
regulated articles under the regulations in 7 CFR part 340
because they contain gene sequences from the plant pathogen
Agrobacterium tumefaciens. These cotton events have 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 cotton, 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, Mycogen/Dow has submitted a request to EPA for
registration of the stacked Cry1F and Cry1Ac protein construct
as a plant-incorporated protectant in cotton.
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. Mycogen/Dow has submitted a request
to EPA for a tolerance exemption for both the Cry1F and Cry1Ac
proteins as expressed in the subject cotton 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, 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.
Mycogen/Dow has begun consultation with FDA on the subject
cotton events.
To provide the public with documentation of APHIS's review
and analysis of the environmental impacts and plant pest risk
associated with proposed determinations of nonregulated status
for Mycogen/Dow's cotton events Cry1F and Cry1Ac, 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's 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 petitions for
determinations 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 determinations for the subject cotton
events. The petitions 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 petitions and
the environmental assessment and other data and information,
APHIS will furnish a response to the petitioner, either
approving the petitions in whole or in part, or denying the
petitions. APHIS will then publish a notice in the Federal
Register announcing the regulatory status of the Mycogen/Dow
insect-resistant cotton events Cry1F and Cry1Ac and the
availability of APHIS's 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 4th day of March, 2004.
Kevin Shea, Acting Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 04-5252 Filed 3-8-04; 8:45 am]
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