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WICHITA, Kan. —(AP)— Less than a year after corn genetically engineered for a hog vaccine ended up in Nebraska soybeans meant for human consumption, government regulators have scrambled to put into place new rules and more inspectors to oversee the developing plant-grown pharmaceutics industry. Genetically modified crops bred to be tolerant of herbicides are nothing new in agriculture, but development of genetically altered crops to produce pharmaceutical proteins or compounds for industrial uses raise new concerns for the food industry. The stakes are huge. Proponents of plant-grown pharmaceutical and industrial crops argue the compounds can be grown in large volumes at less cost than traditional manufacturing methods that use animal proteins. That would make it cheaper to produce medicine and arguably allow pharmaceutical companies to make drugs for more diseases. ``This novel process of using plants can get patients faster access to innovative and lifesaving therapeutics,'' said Lisa Dry, spokeswoman for the Biotechnology Industry Organization. ``What it all comes down to is the manufacturing capacity issue.'' But opponents contend the new ``pharma crops'' will jeopardize the safety of the nation's food supply through accidental cross-pollination of food crops. They fear the genetically engineered crops will erode public confidence in U.S. food crops, harming export markets. ``We have a Kansas farm economy based on producing vast quantities of food and feed,'' said Dan Nagengast, a Lawrence farmer and executive director of the Kansas Rural Center. ``What does that do to the world perspective — the market for Kansas grains?'' On Oct. 17, the U.S. Department of Agriculture announced it was hiring more inspectors and setting up an enforcement unit to enforce regulations adopted earlier this year that strengthen permit conditions for pharmaceutical and industrial crops. Under new rules passed in March, the crops will be inspected seven times during two years to make sure there is no contamination of conventional food crops. The rules also strengthened restrictions for isolation of fields and the use of dedicated farm equipment. In August, the U.S. Department of Agriculture issued additional interim rules also requiring permits for industrial crops similar to those in place for pharmaceutical crops. In the meantime, the USDA is seeking public comment before setting long-term rules by the end of next year. Full commercial development of plant-grown pharmaceuticals is still three to five years away, according to the Biotechnology Industry Organization. But based on current clinical trials, the first beneficiaries of plant-grown pharmaceuticals will likely be patients suffering from cystic fibrosis, herpes and children with iron deficiencies, Dry said. Plant-made pharmaceuticals are typically produced from crops such as corn, tobacco, rice and soy that have been genetically altered to yield medicinal proteins with the same purity as traditional manufactured processes. ``We produce ingredients for drugs — we have no control of the price to consumers. ... We talk about greater access, lower manufacturing costs or fewer hurdles to get a drug into production,'' Dry said. Biotech opponents point to incidents such as the one in Nebraska last year in which pharmaceutical corn got into a subsequently planted crop of soybeans. Although the ``pharma corn'' was found before it actually got into the food chain, the incident was decried by biotech critics. Supporters of pharma crops pointed out that the regulatory system worked. Between 1990 and 2001, USDA cited 115 infractions on 7402 field tests of biotech crops. Eight of the violations resulted in fines ranging from $500 in a few cases to $250,000 in the Nebraska case, which involved ProdiGene. The Nebraska incident was the only one that involved pharmaceutical crops. Among those concerned about the federal regulations is Kansas Agriculture Secretary Adrian Polansky. He wants stricter regulation and more state input before USDA issues permits for such crops in Kansas. ``Certainly biotechnology — whether in the industrial or pharmaceutical area — holds some real potential benefits for Kansas farmers and the health of Kansans and world consumers, but certainly we need to carefully monitor how the steps are taken with the technology,'' Polansky said. Among his concerns is how much of an opportunity state regulators will have to participate in making decisions about what permits will be issued in their states. State regulators now get little information from USDA about proposed pharmaceutical test plots. They are not told the exact location of the test plots or the compounds being genetically engineered in the crops, Polansky said. One of the reasons USDA said it releases so little information about the locations of the crops is that they do not want biotech opponents to ``cause trouble'' at the sites, said Jim Rogers, spokesman for USDA's Animal and Plant Health Inspection Service. Polansky is also concerned the USDA does not have enough inspectors in Kansas to conduct proposed field inspections on pharmaceutical plots. APHIS now has just two inspectors in the state. In his comments to USDA, Polansky also asked for a risk assessment that considers the specific site before a permit is approved as well as consideration of an applicant's prior record. He also wants statistical sampling of non-biotech crops from fields near test plots. In 2002, only one unspecified pharmaceutical crop test field was planted in Kansas, Rogers said. No fields were listed for 2003. Test trials last year consisted of 20 pharmaceutical crop permits for 34 field sites totaling 130 acres across the country, according to USDA. Permits were issued in 14 states. A recent survey of Biotechnology Industry Organization members found 90 acres of pharmaceutical and industrial test crops nationwide this year, Dry said. ``The issue for me is using a commodity crop as a research crop — the fact they have chosen to use corn in the Cornbelt when that just ups the risk of contamination,'' Nagengast said. Those risks could be reduced if the pharmaceutical crop industry would use nonfood crops as host plants, grow fields outside farm states, and further reduce risk by segregating fields as required by USDA, Nagengast said. ``It is an important issue to agriculture, whether producers or food consumers,'' Polansky said. ``It is a very important issue in terms that these products have some real benefits to society in the future.'' |
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