[Federal Register Volume 69, Number 46 (Tuesday, March 9, 2004)]
[Notices]
[Pages 10972-10973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-5252]


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 Notices
                                                 Federal Register
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 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 
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  Federal Register / Vol. 69, No. 46 / Tuesday, March 9, 2004 / 
Notices  

[[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:
     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.
     E-mail: Address your comment to 
[email protected]. 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.
     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.
     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: [email protected]. The petitions are 
also available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/03_03601p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/03_03602p.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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