[Federal Register Volume 69, Number 2 (Monday, January 5, 2004)]
[Pages 315-317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-62]

                                                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.


Federal Register / Vol. 69, No. 2 / Monday, January 5, 2004 / 

[[Page 315]]


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 

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 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, 

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 

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

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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 
    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

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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]