Attention: Docket ID Number OPP-2005-0249

EPA

FIFRA Scientific Advisory Panel

Comments by Seminis Vegetable Seeds

37437 State Highway 16

Woodland, California 95696

Dr. Keith Redenbaugh

Associate Director, Regulatory Affairs

[Keith.redenbaugh@seminis.com]{.underline}

530 669-6170

November 29, 2005

Submitted via [opp-docket@epa.gov]{.underline} and
[Lewis.Paul@epamail.epa.gov]{.underline}

Dear Sir or Madam:

Seminis Vegetable Seeds commercialized the first genetically engineered
(biotech) crop (ZW-20 squash) containing viral coat protein genes in
1995, after receiving the following decisions from US government
agencies:

> · USDA Determination of Non-Regulated Status 12/07/94
>
> · FDA Completion of Consultation 4/5/95
>
> · EPA Exemption from the requirement of a tolerance 11/2/94

Additional approvals were subsequently obtained in Canada for produce
export purposes:

> · Canadian Food Inspection Agency for fruit importation 12/2/97
>
> · Health Canada approval 4/17/98

ZW-20 squash contains coat protein genes from *Zucchini yellows mosaic
virus* and *Watermelon mosaic virus*.

Subsequently, Seminis commercialized a second genetically engineered
squash line (CZW-3) containing three viral coat protein genes in 2000,
after receiving the following decisions from US and Canadian government
agencies:

> · USDA Determination of Non-Regulated Status 5/6/97
>
> · FDA Completion of Consultation 7/11/97
>
> · EPA Exemption from the requirement of a tolerance 8/14/97
>
> · Canadian Food Inspection Agency for fruit importation 12/2/97
>
> · Health Canada approval 4/17/98

CZW-3 squash contains coat protein genes from *Cucumber mosaic virus*,
*Zucchini yellows mosaic virus* and *Watermelon mosaic virus*.

These products have been well received by squash farmers and provide
excellent resistance to the indicated plant viruses. Natural resistance
to these viruses is significantly inferior and does not provide the same
high level of virus resistance. In many cases, farmers have reported
success in producing a squash crop using the biotech varieties whereas
they had crop failure using other varieties due to these viruses.

**Value to U.S. Farmers**

In October 2005, the National Center for Food and Agricultural Policy
reported that the net benefit of planting biotechnology-derived
varieties in 2004 in the US was \$19.25 million. The NCFAP further
reported:

Biotechnology-derived squash varieties accounted for 22, 17, 20, 15, 15,
10, and 2% of the total planted acreage in Florida, Georgia, New Jersey,
South Carolina, Tennessee, North Carolina, and Michigan, respectively,
in 2004. Averaged across the United States, this represents an adoption
of 10%.

The average seed cost for conventional squash was \$208 per acre in 2004
while biotechnology-derived seeds cost \$369 per acre (Coffey 2005;
Ludwick 2005). Thus, seed costs for biotechnology-derived varieties were
78% higher compared to conventional varieties. In spite of high seed
costs, squash growers planted biotechnology-derived varieties in 2004,
primarily as an insurance against yield losses from fall plantings.

Table 2.3 presents the data on the impacts of biotechnology-derived
squash varieties in the seven states listed above. It is assumed that
squash growers would experience complete conventional crop failure (if
not planted with biotechnology-derived varieties) and lose their entire
fall-planted squash production, as virus infestations are particularly
heavy during this season. Therefore, it is assumed that growers that
planted biotechnology-derived varieties in 2004 restored their yields to
original levels. The impact of biotechnology-derived virus-resistant
squash is a gained production of 64 million pounds, valued at \$20.2
million. Based on the assumption that American squash growers paid a
premium of \$0.95 million in seed costs, the net benefit of planting
biotechnology-derived varieties was \$19.25 million in 2004.

Table 2.3. Impacts of biotechnology-derived virus-resistant squash in
2004

  ----------- ----------------- ------------- -------------- ------------ ------------
  **State**   **Acreage planted **Adoption    **Yield        **Gain in    **Net gain**
              to                costs1**      advantage2**   value**      
              virus-resistant                                             
              squash**                                                    

              Acres             \$            Million lb     000\$        000\$

  FL          2310              371910        29.4           9986         9614

  GA          2040              328440        19.6           5670         5342

  MI          144               23184         2.2            325          302

  NJ          640               103040        6.7            2413         2310

  NC          390               62790         3              900          837

  SC          210               33810         2.1            588          554

  TN          180               28980         1.4            317          288

  **Total**   **5,914**         **952,154**   **64.4**       **20,199**   **19,247**
  ----------- ----------------- ------------- -------------- ------------ ------------

> 1Adoption costs = added seed costs due to biotechnology-derived
> virus-resistant squash compared to conventional squash. Average seed
> costs of conventional and biotechnology-derived squash varieties were
> \$208 and \$369 per acre, respectively, in 2004. Therefore, adoption
> costs were \$161 per acre
>
> 2Yield advantage was calculated based on production and
> virus-resistant squash adoption information

The Center for Food and Agricultural Policy concluded that \"***It is
assumed that squash growers would experience complete conventional crop
failure (if not planted with biotechnology-derived varieties) and lose
their entire fall-planted squash production, as virus infestations are
particularly heavy during this season***\" \[emphasis added\]. Farmers
in these virus-prone states depend on these biotech virus-resistant
varieties. Plant breeders have been unable to develop comparable squash
varieties with traditionally-bred resistance.

**USDA APHIS oversight is sufficient and adequate**

USDA APHIS conducted a rigorous 2-year review prior to its Determination
of Non-Regulated Status for the virus-resistant ZW-20 squash line (and
later, a similar review for CZW-3). The Determination was supported by
several years of data accumu­lation from initial contained tests in the
greenhouse, and small-scale field trials to large-scale field trials.
These tests included studies on gene flow, weediness potential, and
viral interactions such as encapsidation. During the deregulation
process USDA solicited public comments on the petition and the comments
received were carefully considered. Furthermore, USDA consulted state
extension agents in relevant states and USDA requested additional
studies from Asgrow (now part of Seminis Vegetable Seeds), which were
performed. All this was done in addition to the usual independent
scientific literature survey and expert consultations USDA routinely
does on top of the voluminous information requested of petitioners.

The issues before this EPA Science Advisory Panel are important
questions, which USDA APHIS has considered when making its
Determinations of Non-Regulated Status for PVCP-PIPs, specifically in
the areas of gene flow, weediness, wild relatives, and viral
interactions. USDA APHIS has now a 13-year history of making PVCP-PIP
Determinations. Under FFDCA and FIFRA, EPA can finalize an exemption
from regulation for PVCP-PIPs and not create an unnecessary and
duplicative registration process that USDA APHIS adequately covers.
**Seminis strongly believes that EPA should categorically exempt all
viral coat proteins from FFDCA and FIFRA regulation and consult with
USDA as necessary.**

**Loss of product**

Since 1994, Seminis has conducted research on other PVCP-PIP vegetables,
including tomato and melon. In most cases, the PVCP-PIPs resulted in
biotech plants that had excellent resistance to the target viruses. If
such resistance had come from wild relatives via wide hybridization
techniques, as has been done in plant breeding for decades, these virus
resistant varieties would have been commercialized and farmers today
would be benefiting from improved virus resistance. However, because of
the regulatory costs to obtain approvals of PVCP-PIPs (including the
possibility of PIP registration with the EPA), Seminis determined that
the value-added components of these other PVCP-PIPs would not be
sufficient to pay for the regulatory approvals. Therefore, the vegetable
PVCP-PIP projects were discontinued, which is unfortunate for farmers
who still must battle virus infestations.

It should be noted, that under today\'s regulatory burden, Seminis would
not be able to justify the investment to create our two existing biotech
squash products, ZW-20 and CZW-3, which are currently providing
significant benefit to American farmers. Squash is not a high-value
crop. The premium that farmers are willing to pay for virus resistant
squash is simply not enough to cover today\'s regulatory expenses. **In
fact, because of PIP registration costs, it is likely that these virus
resistant squash varieties would have to be removed from the market
should they no longer be exempt from the requirement of a tolerance
under** **FFDCA and FIFRA**. This would place a significant burden on
those farmers who have come to depend on these varieties in order to
produce marketable crops.

**Seminis request and recommendation**

**Seminis strongly recommends that the EPA continue to provide exemption
from regulation for PVCP-PIPs**. USDA adequately addresses the issues
raised by EPA, including gene flow, weediness, transencapsidation and
recombination and has held numerous public fora and workshops to gather
information and obtain public input on PVCP-PIPs. EPA registration is
unnecessary and duplicative of the USDA oversight it has provided for 13
years.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**Dr. Keith Redenbaugh**

Associate Director

Regulatory Affairs

Seminis Vegetable Seeds

37437 State Highway 16

Woodland, California 95695

( Phone: 530 669 6170

( Fax: 530 666 4426

\* E-mail: keith.redenbaugh@seminis.com