Following weeks of failed attempts to set up a live interview, at Ventria’s request, Delta Farm Press agreed to offer a written list of questions. Below, are DFP’s questions and answers provided by Scott Deeter, Ventria CEO. They are presented unabridged.
Before getting to the bulk of the questions, please describe the benefits (both pharmaceutically and financially) Ventria’s pharm-rice will provide to consumers.
“Ventria is producing two proteins, Lactoferrin and Lysozyme. Both of these proteins are found in tears, saliva, bronchial fluids and as important components in mother’s milk. These proteins have antimicrobial, anti-inflammatory and iron binding properties. Ventria is currently developing an Oral Rehydration Solution including lactoferrin and lysozyme to manage diarrhea and dehydration. Ventria believes that the addition of these two proteins to an Oral Rehydration Solution will provide improved management and intestinal protection, not just rehydration of the child. According to the World Health Organization, on a worldwide basis 1.3 million children under the age of 5 die of acute diarrhea worldwide. Several other health products utilizing Lactoferrin and/or Lysozyme are in development at Ventria.
“Ventria utilizes rice and barley to produce these therapeutic proteins and estimates the cost would increase by more than thirty times to produce the same proteins using other systems of production. Plant-made pharmaceuticals have the potential to provide patients with the benefit of greater access to necessary medicines.”
1. Can Ventria guarantee that its pharm-rice (or its pollen) won’t somehow find its way into neighboring (conventional) rice fields?
“Ventria utilizes a closed system of production that includes self-pollinating plants to produce plant-made pharmaceuticals. Self-pollinating plants contain the male and female reproduction system within the same plant and do not require wind or insects for pollination and reproduction. This significantly reduces the risk from cross-pollination. Also, Ventria produces its product in the seed of rice only during the last month of the growing phase of the plant. Thus, the product is not present in the leaf, stems, or root material.
“In addition, Ventria is completely committed to sound stewardship practices and has passed every USDA inspection for the past six years including eight inspections in 2004. Ventria maintains chain of custody for all of its plant-made pharmaceutical crops and we have a very stringent production protocol to maintain quality and containment.
“In order to maintain product quality and as part of Ventria’s commitment to sound stewardship, Ventria has instituted the following production practices:
· Ventria’s field production will be grown in areas that are separated from commercial rice production by considerable distance.
· Ventria’s products are manufactured within the seed of self-pollinating rice or barley, which are not wind or insect pollinated plants;
· Ventria’s field production, storage, grinding and transportation equipment is dedicated only to Ventria’s use and is not used for any commodity rice or barley production.
· Ventria’s collaborators and field production personnel receive extensive training related to regulatory requirements and Ventria’s standard operating procedures.
“Ventria monitors its production practices for compliance and performs frequent audits of its operations. Ventria is also inspected numerous times by USDA for permit compliance. As you know, this ‘closed’ system is nothing like the ‘open’ systems used today for food production.”
1-A. If so, is Ventria’s guarantee backed by anything more than words?
“Please see above.”
1-B. If not, who will pay any affected Delta rice farmers for lost income? Will Ventria make up for any such losses?
“Please see response to question 1. We have very stringent USDA regulations and standard operating procedures in place to maintain chain of custody for our rice.”
1-C. Has Ventria looked into the possibility of taking out an insurance policy for those farmers if contamination occurred?
“Please see above response.”
2. If allowed, how much Ventria pharm-rice will be grown this year (acres)? How much is planned for next year? Is there an acreage plan for the years after?
“Ventria has submitted its 2005 production permit application to the United States Department of Agriculture (USDA) for 200 acres. The 2005 permits would authorize production in Cape Girardeau, Scott and Mississippi counties in Missouri. Ventria has received approval from the USDA and has produced its products every year since 1999.
“Acreage requirements beyond 2005 are difficult to predict, it will depend primarily on Ventria’s business plan and the success of our products in meeting the health needs of our customers.”
2-A. How far from “conventional” rice fields is/are Ventria’s Bootheel field(s) being grown?
“Ventria’s field site is located in an area that does not grow rice today. Rather, the surrounding fields are planted to corn and soybeans. The nearest rice field is 4 miles away and there is no rice to the North, East or West of the proposed growing area.”
3. Viable seed are often passed through birds’ digestive systems. There have been claims that Ventria’s pharm-rice will more easily break down in birds’ guts. Does this eliminate the chance that birds (ducks or otherwise) will disperse this seed in neighboring rice fields?
“There are two studies that look at the issue of the viability of grain in waterfowl digestive systems. The results of both studies show that rice is highly digestible by waterfowl and that no viable rice passes through the digestive system of ducks or geese. Rice is easily digested by birds, unlike weed seeds that have a hard seed coat. In fact, it is suggested that attracting birds to a field containing red rice is a viable weed management practice because the birds effectively digest the red rice and render it non-viable. Red rice has an even harder seed coat than Ventria’s rice variety, so there is less likelihood of birds transporting rice in this manner. Please see the following papers for more information:
“Seed Distribution By Waterfowl In Southwestern Louisiana” J. Wildlife Management 42(3) 1978 598-605Powers, K.D., R.E. Nobel, R. H. Chabreck
“Reduction of Red Rice Grain in Rice Fields by Winter Feeding of Ducks” Arkansas Farm Research 29(4) 1980 pg. 3 Smith, R.J. Jr. and J.D. Sullivan
3-A. How does Ventria propose to keep its pharm-rice from dispersing to neighboring rice fields through flooding?
“Ventria will have a levee and a 50 foot fallow area around its field to keep all water in the field. All of the water that is removed from Ventria’s field will be pumped into a sediment pond. The water will be pumped out of the sediment pond through a screen that will catch any rice seeds that are present in the water.”
3-B. How does Ventria propose to keep its pharm-rice from dispersing to neighboring rice fields through pollen carried on the wind?
“Rice is a self pollinated plant and the life of its pollen is only a few minutes. That means that rice has both male and female organs contained within the same plant, rather than relying on insects or wind to carry pollen for reproduction. One recent paper addressing the many studies on rice self-pollination is:
“Gene Flow Between Red Rice and Herbicide-Resistant Rice: Implications for Weed Management” Weed Technology, 2003, Volume 17:627-645.
“For these reasons, many research studies determined that 10 feet was an adequate distance between rice seed fields to maintain purity of Foundation Seed (highest purity standards). More recent studies have shown that outcrossing in even adjacent plants is unlikely. No studies have shown outcrossing beyond 30 feet. Since Ventria utilizes a 50 foot fallow area and a distance of more than 4 miles to another rice field, redundant safeguards are in place to prevent an event as you described.”
3-C. How does Ventria propose to keep its pharm-rice from dispersing to neighboring rice fields through pollen carried by insects?
“As stated in the previous answer rice is self-pollinating and does not rely on insects for pollination.”
3-D. How does Ventria propose to keep its pharm-rice from dispersing to neighboring rice fields through movement of equipment or human error?
“Ventria owns its own field production, storage, transportation and milling equipment, which is dedicated to Ventria’s production. In Ventria’s ‘closed’ system of production viable seed does not leave the farm. It is processed into a non-viable powder before shipment.
“It is important to clarify that Ventria maintains ownership and chain of custody of the rice or barley throughout the entire production process from the field to the purified protein.”
4. Why can’t Ventria grow its pharm-rice in indoor facilities?
“One of the distinct advantages that plant made pharmaceuticals have is the ability to scale-up and produce large quantities of pharmaceuticals in an affordable system. Working with the United States Department of Agriculture, Ventria has developed a system to safely produce these therapeutic proteins and maintain a sound stewardship philosophy.”
5. Why relocate to a state where rice is already grown? Could Ventria not find a suitable location – perhaps to grow its pharm-rice under pivot – further away from major rice producers in the Delta?
“During 2004, Ventria decided to evaluate its options for commercial production going forward and was heavily recruited by six states in addition to Missouri. Ventria’s relocation to Missouri would not have been possible without the leadership and vision of Dean Hubbard (President of NWMSU), Mel Booth (former President of MedImmune, Human Genome Sciences and NWMSU alumnus), Senator David Klindt, Representative Brad Lager, Terry Maglich, Missouri Department of Economic Development, the Missouri Department of Agriculture and Lee Langerock, Nodaway County Economic Development.
“Ventria selected Missouri for the following reasons:
1) the establishment of the Center of Excellence in Plant-made Pharmaceuticals by Northwest Missouri State University provided the necessary infrastructure for Ventria to commercialize its products;
2) the economics of field production in Missouri and the high quality land and water resources were attractive compared to Ventria’s alternatives, especially California;
3) the capabilities and expertise of Missouri’s growers, especially their experience with biotechnology-based crops such as soybeans and maize;
4) The State of Missouri is a leader in the development and commercialization of biotechnology from St. Louis (Danforth Plant Science Center, Botanical Gardens, and Washington University) to Columbia (University of Missouri) to Maryville (NWMSU) to Kansas City (Stowers Biomedical Research Institute, KU Med Center), there are many institutions in the region that provide the critical mass of talented people that make knowledge-based businesses like biotechnology successful.”
6. Why is Ventria growing its pharm-rice in the Bootheel, when it’s headquartered at Northwest Missouri State hundreds of miles away?
“Ventria will produce in Scott County and in Northwest Missouri this year and will process at the field production location into a powder. This powder serves as the feedstock to an extraction process that will be based at Northwest Missouri State Univeristy’s campus in Maryville, Mo. We need to have a location that provides both efficient field production and the infrastructure for extraction, which is why we are producing in both locations.”
7. Could Ventria’s pharm-rice traits be passed to red rice or other weeds?
“Ventria will keep its field free of red rice (as describe in section 13e of the permit application) by manual rouging and/or chemical application. Ventria’s present seed stock (developed in California) is also red-rice free.”
8. Is Ventria – or its attorneys – prepared/preparing for the possibility of a legal injunction against the planting of its pharm-rice?
9. Why did Ventria decide to leave California?
“Ventria received approval from the California Rice Commission, the California Department of Food and Agriculture and the USDA to grow plant-made pharmaceutical rice in California. In 2004 and in 2003 Ventria grew its rice in California and its barley in Iowa.
“See above for the reasons we selected Missouri over other states that recruited Ventria.”
10. Did Ventria approach someone in Missouri about re-locating there or did someone from Missouri contact Ventria? Either way, when was the move first discussed?
“Officials from Missouri contacted Ventria.”
10-A. Who was (were) Ventria’s first contact(s) when contemplating the move to Missouri?
“Several contacts were made with officials from Northwest Missouri State University, Missouri Department of Economic Development, Missouri Department of Agriculture, University of Missouri at Columbia, legislators, farmers and leaders within the research institutions within the State of Missouri.”
10-B. Was Ventria offered financial incentives by the state of Missouri to relocate?
“The reasons for Ventria’s decision to relocate are listed in question 9.”
10-C. Did Ventria have any responsibility to inform Bootheel rice growers that it would be moving into the area?
“Before making the decision to relocate to Missouri, Ventria met with a number of local representatives to discuss its plans to grow and with their help, Ventria selected an area that does not have rice production today.”
10-D. Was the resistance – mostly for market-loss fears – by many Delta rice growers to Ventria’s plans in the Bootheel a surprise or was the company expecting it?
“First, many growers are quite positive and have been influential in Ventria’s plans to grow in Missouri. Second, Ventria described its plans to growers in Southeast Missouri during a recent meeting in Dexter, Mo. This meeting provided an opportunity to share our plans with growers and to address concerns. As we heard in this meeting, there are many growers that are supportive of the opportunity that plant-made pharmaceuticals offer to bring opportunities for rural development and Missouri agriculture.”
11. In light of the federal government’s stated “zero tolerance” standard for plant-made pharmaceuticals in food, how does Ventria view Delta rice growers’ concerns about the potential of pharm-rice contamination ruining the market for their crops?
“This is an issue that is the basis of the USDA regulatory process and has been addressed with the above protocol, which has been reviewed by USDA.”
12. Is Ventria doing anything to open foreign markets in case their pharm-rice does contaminate neighboring crops?
“Please see above comments.”