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Biopharming has pros, cons

(Sunday, Oct. 31, 2004 -- CropChoice news) -- Aine Gianoli, DTN:
KNIERIM, Iowa --Scientists are seeking cheaper, more efficient ways to produce products used in pharmaceutical drugs and they're turning to agriculture for help.

The production of pharmaceutical and industrial compounds within crops such as corn, tobacco and alfalfa unites the medical and agricultural industries. Though plant-made pharmaceuticals have yet to be approved for commercial production, companies are growing their own test plots or are contracting with farmers under regulations from the U.S. Department of Agriculture.

In 2001, Joe and Bill Horan became the first farmers to receive a permit from the USDA to grow a pharmaceutical crop test plot.

"We are doing this for the good of mankind and not its detriment," Joe Horan said in an interview with DTN. He and his brother are hoping the first crop they grew, corn containing the protein lipase, will help elongate the lives of children with cystic fibrosis.

Leaning against the fence enclosing a 12-foot-by-12-foot test plot of genetically engineered barley, Joe Horan said the brothers' latest biopharm plants are barley containing lactoferrin, a protein that retards bacterial and fungal growth, and corn containing a compound to fight E. coli.

In the past four years, the Horans have spent hours learning about, implementing and explaining the biopharming business in hopes of revitalizing their community, turning a profit and launching a new industry.

Their adventure started when they read a magazine article about biopharming. In the summer of 2000, the brothers decided to e-mail one of the authors, a molecular biologist with Meristem Therapeutics in France, telling him if he ever needed farmers to grow something, they'd be interested.

"In the end of August, we received a reply saying 'That's a great idea. When can we meet?'" Joe Horan said. In October, the brothers flew to France and agreed to grow the first pharmaceutical corn test crop in the U.S. "It was basically a handshake deal. They've been wonderful people to work with."

Since that first deal, media attention has spread the Horan name to other pharmaceutical companies.

Inside one of the farm's shops, Joe Horan flipped on the lights to reveal a six-row planter, a custom single-row planter and two John Deere combines. The equipment is isolated from their other machinery.

"That combine will never combine anything but lipase corn," he said, pointing to the one in the corner. USDA regulations stipulate that equipment cannot be used for anything other than the pharmaceutical crop for which it was first used.

That regulation does not apply to the single-row planter built at Iowa State University because the Horans wrote a proposal for the USDA, describing how it would be dismantled, cleaned, rebuilt and used for other pharmaceutical crops. USDA officials agreed to the proposal because the planter would be like new once cleaned.

"They (the regulators) are very open to you if you have an idea that makes sense," he said. "They are very common-sense oriented."

Equipment isolation is only one of the many Animal and Plant Health Inspection Service's Biotechnology Regulatory Service guidelines farmers must follow. The agency issues permits and regulations for crop production, transportation and importation.

Pharmaceutical crops must have a fallow area around them. A one-mile border has to surround open-air corn test plots. The Horans' barley has a 50-foot border of mown soybeans around it. Rather than leaving the soil bare, some plant growth is allowed to prevent erosion.

"We don't just want black ground out here," Joe Horan said. "Our soils tend to blow."

This year, they aren't growing pharmaceutical corn on their Iowa farm. They have a one-fifteenth acre plot in Colorado.

"We looked all over the state of Iowa (for a spot), but it was too late in the year," he said. "We went out in the spring and planted the crop so now we are Colorado farmers, I guess. The land has to be in our control for two years."

During those two years, the Horans will follow a strict routine.

Federal and state regulators observe planting of the pharmaceutical crop, which is done the first year. Cultivation practices are the same as those for regular crops, but before treating the plants with any type of chemical, regulators must be notified. Throughout production, regulators visit the site.

After harvest, the grain is loaded into a wagon that has a drying floor, a fan is attached to the wagon and the grain is left to dry for about a month. When dry, the corn is sorted on a gravity table.

"Everything is destroyed that is not good-quality corn," Joe Horan said. "It has to be buried and incinerated."

The corn is then sealed into plastic containers, plastered with permit and shipment information and sent to the pharmaceutical company.

Plant residue left in the field after harvest is disked under, leaving a small amount on the soil's surface to prevent erosion. During the second year, a crop can be planted that will be destroyed before harvest, or the field may remain fallow. The Horans planted Roundup Ready soybeans after growing lipase corn and sprayed the beans at least twice to kill volunteer corn. Before harvest, the entire bean crop was destroyed to ensure no genetically engineered plants would leave the field.

"We just can't have any mistakes. We watch everything we do," Joe Horan said. "We try to be as transparent as we can for the regulators."

But acceptance of crops containing proteins and other compounds may be slow in coming. Not only are environmental groups voicing concerns, some farm organizations are opposing pharmaceutical crops.

"It seems the risk would outweigh the benefits," said Dan McGuire, director of the American Corn Growers Foundation's Farmer Choice-Customer First program. "We look at what impact it (biopharming) is going to have on corn because that affects every corn farmer.

"How many acres would it take to meet the demand of a certain pharmaceutical? How many farmers would benefit?"

While helping a small portion of corn farmers, the technology could hurt all other farmers if it hurts markets, he said.

McGuire said the United States has lost export markets because of biotech crops and is runs the risk of losing more if it pursues plant-made pharmaceutical technology.

The American Corn Growers Foundation wants farmers to have the freedom to pursue crops that are beneficial and profitable, he said, but they also need to have information on how foreign markets will react.

"It's a marketing issue," he said. "It is not a simple matter now that we are in this globalized arena of agriculture."

Nathan Danielson, director of biotech and business development for the National Corn Growers Association, said the NCGA is cautious but optimistic about the potential biopharmaceutical crops hold for its growers, but doesn't want one opportunity to overwhelm another opportunity.

"From the cost-benefit standpoint, is the new technology valuable enough to merit the additional cost?" he said. "If we do it wrong, the costs will be unimaginable."

Joe Horan said current government regulations are working and will prevent problems.

"Nothing is impossible, but it is as close to impossible as you are going to find," he said.

But those who are reluctant to accept pharmaceutical crops point to past accidents as evidence that the system has too many loopholes.

In 2000, genetically modified Starlink corn, which had been approved for animal feed but not human consumption, was discovered in taco shells. In 2002, volunteer corn plants containing pharmaceutical proteins were discovered in Iowa and Nebraska soybean fields where ProdiGene tests were done the year before. The corn was not removed before the soybeans were harvested, resulting in the contamination of nearly 500,000 bushels of soybeans.

When asked about Starlink, Joe Horan said he'd like to talk to people worried about that incident and have them visit his farm. People tend to change their minds once they visit the farm and see how the regulations are implemented, he said.

"We spend so much time on education," he said. "That is the biggest pull on our time. We aren't hiding out here." The brothers have been guest speakers for a variety of groups, sharing about their experiences with biopharming.

"There are some people you are never going to convince of sound science. That's just the way it is, but we continuously try. You don't have to toot your own horn, but you have to be visible."

Joe Horan said his neighbors all know the test plots are there, but he hasn't heard any complaints. And he has support from a group of farmers who are interested in the plots.

"We haven't really heard anything negative. Most people in Iowa understand the biotech issue," said Ron Mortensen, managing director of the Iowa Cooperative, a group of 70 family farmers who are either interested in growing pharmaceutical crops or just knowing more about them. Some of them have grown test plots, including some genetically engineered tobacco.

"This is not something that everyone is going to participate in," Joe Horan said. "There's paperwork upon paperwork to be filled out and it has to be done in a timely manner. This is outdoor manufacturing."

In the future, Joe Horan said, he and his brother want some of the cooperative's members to share equipment ownership and rotate land to meet the mile-wide border requirements for open-air pharmaceutical corn test fields.

Chris Petersen, a farmer in the Clear Lake area and president of the Iowa Farmers Union, said pharmaceutical crops shouldn't be grown in areas where the plants are grown as a commodity.

"The science is not in to make this a viable economic option for Iowa," he said.

Pharmaceutical corn can be grown, Petersen said, but not in the Corn Belt.

"This is the technology age. We need to push forward so we can get smarter and save more lives," he said. "I believe this (pharmaceutical crop) researching, development and testing should continue, but we need to do all of this safely."

Regulations for pharmaceutical crops have to be stringent and penalties for failing to meeting rules should be strict, he said. Drug companies need to be held fully accountable for the crops, preventing blame from falling solely on farmers if glitches occur.

Setting aside all other concerns, Petersen said, pharmaceutical crops wouldn't boost rural economies because they affect few farms.

"If we are going to have rural economic development, we need prices for commodities that all farmers are growing," he said.

But farmers in the Iowa Cooperative hope biopharming will increase farm profitability and rural viability.

Though it's unlikely biopharming will require many acres or affect many farmers, Joe Horan said, he's hoping it will give young people a way to build the equity needed to purchase a farm.

"The Masons and Rockwell Cities of the world are getting gray," he said. "We've progressed from simply making money for the Horan brothers (goal) to bringing vitality back to the Midwest.

"Maybe it will never happen. Maybe the naysayers will win. Maybe we will have wasted the last six to seven years, but I don't think so. I think it will happen."