November 29, 2005

Attention: Docket ID Number OPP-2005-0249

Dear Sir or Madam,

Monsanto Company is a leading provider of agricultural products and
solutions to growers worldwide. Monsanto uses plant biotechnology,
genomics and breeding to improve agricultural productivity and
sustainability and reduce the costs of farming. We produce leading seed
brands and develop biotechnology traits and herbicides that can be
combined to offer farmers cost-effective and integrated solutions to a
variety of agricultural challenges.

In 1994, EPA proposed two options to plant exempt viral coat proteins
from regulation under FIFRA and FFDCA based on plant viral coat proteins
(PVCPs) having a lower overall lower risk compared to other
plant-incorporated protectants (59 FR 60496), and based on advice from a
Subpanel of the FIFRA Scientific Advisory Panel that convened on Dec.
18, 1992. The first alternative was a full categorical exemption for all
PVCPs; the second alterative was an exemption for those PVCPs with the
lowest potential to confer selective advantage to wild or weedy plant
relatives. **Monsanto supports Option 1 and recommends that EPA exempt
from FFDCA and FIFRA regulation the expression of viral coat proteins
engineered into crop plants for the purpose of virus resistance** .

In 2000, the National Research Council (NRC, 2000) published a review of
the US regulatory system for plant biotechnology products and
recommended that EPA should not categorically exempt viral coat proteins
under FIFRA. This recommendation was based primarily on NRC\'s view that
there is a lack of information on the effects of gene transfer from crop
plants to weedy or wild relatives. In 2001, EPA published a supplemental
Federal Register Notice (66 FR 37855) on the proposed viral coat protein
exemption and requested additional public comments, due in part to the
NRC comments. EPA noted that the potential for most plants containing
plant-incorporated protectants to pose weediness concerns is directly
considered by USDA/APHIS under the Plant Protection Act (PPA). EPA also
acknowledged that there is a potential for duplicative oversight with
respect to certain issues that may arise in plant-incorporated
protectant decisions and committed to work with USDA to avoid potential
duplication and inconsistencies . Monsanto agrees with the NRC that the
impact of the virus resistance trait on weediness of a related species
should be considered as part of the risk assessment for the
biotechnology-derived plant; however, Monsanto does [not]{.underline}
agree with NRC that a categorical exemption of PVCPs (Option 1) by EPA
would leave a \"gap\" in the regulatory system since this issue is fully
addressed by USDA in regulating PVCPs.

USDA-APHIS has regulatory responsibility under the Plant Pest Act and
Noxious Weed Act (now replaced by the Plant Protection Act) for
preventing the dissemination of plant pests in the US. This
responsibility includes regulation of plants modified for virus
resistance through the use of genetic modification or through technology
such as cross-protection using a mild virus strain. To date, USDA-APHIS
has reviewed five petitions for virus resistance, four of them using
coat protein-mediated resistance. In each case, USDA-APHIS specifically
evaluated in an Environmental Assessment the potential environmental and
agricultural impacts, including weediness of the virus resistant plant,
recombination, transencapsidation or synergism and the potential for
production of a more virulent viral strain.

Prior to and subsequent to the commercialization of any PVCP plant, USDA
has sponsored or participated in numerous workshops on virus resistance
technology to develop and refine their regulatory and science expertise
related to viral resistant plants. These workshops involved government
and academic scientists, technology providers, and environmental groups.
Issues related to virus resistant technology focused on the impact of
outcrossing to wild weedy relatives, recombination, synergy, and
transencapsidation. A comprehensive list of these meetings and their
conclusions are published at
[http://www.aphis.usda.gov/brs/technical_resources.html]{.underline} .

Monsanto believes that EPA regulation of PVCPs would be duplicative and
result in an unnecessary and costly burden for developers, especially
small companies that may be developing products such as virus-resistant
vegetables or other minor crops. USDA is responsible for evaluating the
impact of outcrossing for all biotechnology-derived plants regardless of
whether they are also PIPs. Having a single Agency responsible for
evaluating and setting regulatory policy for issues such as weediness
will maintain consistency and avoid confusion for both the regulated
community and other interested parties. **Therefore, Monsanto believes
EPA should categorically exempt all viral coat proteins and consult with
USDA as appropriate.**

Sincerely,

Keith Reding, Ph.D.

Regulatory Affairs Manager

Monsanto Company

References

Moury, B. C. Morel, E. Johansen, and M. Jacquemond. 2002. Evidence for
diversifying selection in Potato virus Y and in the coat protein of
other potyviruses. J. Gen. Virol. 83:2563-2573.

National Research Council. 2000. Genetically M odified Pest Protected
Plants:

Science and Regulation. Nationalal Academy Press, Washington, DC.

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