[Federal Register Volume 69, Number 2 (Monday, January 5, 2004)]
[Notices]
[Pages 315-317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-62]
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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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Federal Register / Vol. 69, No. 2 / Monday, January 5, 2004 /
Notices
[[Page 315]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 03-101-1]
Monsanto Co. and The Scotts Co.; Availability of Petition for
Determination of Nonregulated Status for Genetically Engineered
Glyphosate-Tolerant Creeping Bentgrass; Request for Information and
Comment
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 and
The Scotts Company seeking a determination of nonregulated status for
creeping bentgrass (Agrostis stolonifera L.) designated as event
ASR368, which has been genetically engineered 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 creeping
bentgrass presents a plant pest risk. We are also requesting
information and public comment on certain issues pertaining to the
potential environmental effects of the subject bentgrass.
DATES: We will consider all comments we receive on or before March 5,
2004.
ADDRESSES: You may submit comments by postal mail/commercial delivery
or by e-mail. If you use postal mail/commercial delivery, please send
four copies of your comments (an original and three copies) to Docket
No. 03-101-1, Regulatory Analysis and Development, PPD, APHIS, Station
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state
that your comments refer to Docket No. 03-101-1. If you use 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. 03-
101-1 on the subject line.
You may read a copy of the petition for a determination of
nonregulated status submitted by Monsanto Company and The Scotts
Company and any comments we receive on this notice of availability in
our reading room. The reading room is located in room 1141, 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 that someone is available to help
you, please call (202) 690-2817 before coming.
APHIS documents published in the Federal Register, and related
information, including the names of organizations and individuals who
have commented on APHIS dockets, are available on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Dr. Bruce MacBryde, BRS, APHIS, Suite
5B05, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-
5787. To obtain a copy of the petition, contact Ms. Kay Peterson at
(301) 734-4885; e-mail: [email protected]. The petition is
also available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/03_10401p.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 April 14, 2003, APHIS received a petition (APHIS Petition No.
03-104-01p) from Monsanto Company of St. Louis, MO, and The Scotts
Company of Gervais, OR (Monsanto/Scotts), requesting a determination of
nonregulated status under 7 CFR part 340 for a creeping bentgrass
(Agrostis stolonifera L., synonym A. palustris Huds.) designated as
event ASR368 (event ASR368), which has been genetically engineered for
tolerance to the herbicide glyphosate. The Monsanto/Scotts petition
states that the subject creeping bentgrass should not be regulated by
APHIS because it does not present a plant pest risk.
As described in the petition, event ASR368 has been genetically
engineered to express a 5-enolpyruvylshikimate-3-phosphate synthase
protein from Agrobacterium sp. strain CP4 (CP4 EPSPS). The CP4 EPSPS
enzyme confers tolerance to glyphosate herbicides. Expression of the
added genes is controlled in part by gene sequences from the plant
pathogens cauliflower mosaic virus and A. tumefaciens. Particle
bombardment technology was used to transfer the added genes into the
recipient creeping bentgrass cultivar Backspin.
Creeping bentgrass event ASR368 has been considered a regulated
article under the regulations in 7 CFR part 340 because it contains
gene sequences from plant pathogens. This creeping bentgrass has been
field tested since 2000 in the United States under APHIS notifications.
In the process of reviewing the notifications for field trials of event
ASR368, APHIS determined that the trials, which were conducted under
conditions of reproductive and physical containment 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
[[Page 316]]
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. Monsanto/Scotts have filed a proposed
supplemental label for Roundup PRO herbicide for uses in seed
production of glyphosate-tolerant creeping bentgrass and a separate
supplementary label for Roundup PRO herbicide for general weed control
in glyphosate-tolerant creeping bentgrass turf, planted to golf course
tees, greens, and fairways. 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. A
determination has been made that a revision of the existing tolerance
is not necessary for a minimal use of creeping bentgrass straw and
chaff as animal feed.
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. The
petitioners have provided to FDA a summary of the animal feed safety
and nutritional assessment of event ASR368 to permit the feed use of
glyphosate-tolerant creeping bentgrass straw and chaff. On September
23, 2003, FDA notified the petitioners that no further questions
remained to be considered.
In accordance with the regulations in 7 CFR 340.6(d), 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 any interested person for a period of 60 days
from the date of this notice. We are also soliciting data, information,
and comments on the following matters to inform our review and analysis
of potential risk assessment issues and environmental effects
associated with a proposed determination of nonregulated status for
creeping bentgrass event ASR368.
APHIS has done a preliminary risk assessment (available on the
Internet at http://www.aphis.usda.gov/brs/aphisdocs/03_10401p_ra.pdf)
and reached the following conclusions:
1. ASR368 contains a single insert of two EPSPS genes that are
inherited as a single Mendelian locus.
2. There appear to be no major unintended effects resulting from
the introduction of the EPSPS gene into the creeping bentgrass genome.
3. ASR368 is not sexually compatible with any Federal threatened or
endangered species.
4. ASR368 is not sexually compatible with any species on the
Federal noxious weed list.
5. ASR368 is not significantly different from its parental line or
null comparators except for its tolerance to glyphosate.
6. ASR368 does not differ in pest and pathogen susceptibility or
resistance from its parent.
However, unlike all deregulated articles previously considered by
APHIS, creeping bentgrass is a widespread perennial species that
establishes without cultivation in various habitats. Furthermore, as
noted in the preliminary risk assessment, creeping bentgrass can form
hybrids with at least 12 other U.S. naturalized or native species of
Agrostis (bentgrasses) and Polypogon (rabbit's-foot grasses). These
circumstances raise the possibility that glyphosate-tolerant creeping
bentgrass and/or glyphosate-tolerant relatives would establish in
various urbanized to rural and natural areas.
We are especially interested in receiving information pertaining to
the following questions:
1. In which environments and crops (and locations) are creeping
bentgrass and/or its sexually compatible relatives controlled or
managed by herbicides, mechanical measures, and/or biological agents?
2. What are the intents and practices for the targeted or secondary
control or management of creeping bentgrass and its sexually compatible
relatives, to what extent is glyphosate used, and what are alternative
herbicides that could be used?
3. What would be the cumulative effects from commercialization of
glyphosate-tolerant creeping bentgrass, and how might these effects be
monitored and mitigated by deployment (release) strategies or
management practices?
(a) To what extent would glyphosate-tolerant creeping bentgrass
and/or glyphosate-tolerant relatives become a problem in the
glyphosate-tolerant crops? How might this potential problem be
controlled or mitigated through management?
(b) What is the likelihood of glyphosate-tolerant creeping
bentgrass contaminating non-glyphosate-tolerant grass seed production?
Are there management measures that could reduce this potential problem?
(c) To what extent would the development of resistant weeds or weed
shifts in bentgrasses production be accelerated as compared to existing
practices? Are there management practices that could be implemented to
delay resistance?
(d) What environmental or management problems would be raised by
the intentional or unintentional stacking of herbicide-tolerant traits
in Agrostis?
The petition and any comments received on this document are
available for public review, and copies of the petition 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 petitioners, all written comments received during the
comment period, and any other relevant information. After reviewing and
evaluating the comments on the petition and other data and information,
APHIS will prepare an environmental document in accordance with the
requirements of the National Environmental Policy Act of 1969, as
amended (42 U.S.C. 4321 et seq.), to examine any potential
environmental impacts associated with a determination of nonregulated
status for the subject
[[Page 317]]
creeping bentgrass. The environmental document will be made available
for public comment. After reviewing and evaluating the comments on the
environmental document 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
Monsanto/Scotts creeping bentgrass event ASR368 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 29th day of December, 2003.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 04-62 Filed 1-2-04; 8:45 am]
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