Cheri Zagurski

DTN Senior Market Editor

OMAHA (DTN)--Changes in the regulation of crops grown for industrial and pharmaceutical uses, including more on-site field inspections, were announced, March 7, by U.S. Department of Agriculture's Animal and Plant Health Inspection Service at a press conference in Washington, D.C.

Other changes to growing guidelines include:

--Strengthening permit conditions to field test plants for industrial uses.

--New buffer zone requirements for pharmaceutical crops.

--Requirements for harvest and planting equipment dedicated strictly to the pharmaceutical crop.

--Increased training requirements for employees of companies involved in producing pharmaceutical crops.

These changes will "make absolutely certain there are no Prodigene incidents in the future," said APHIS Administrator Bobby Acord. Acord was referring to this past summer when volunteer pharmaceutical corn contaminated an elevator full of soybeans in central Nebraska.

APHIS has been inspecting every field test site at least once a year, said Cindy Smith, acting deputy administrator of biotechnology and regulatory services for APHIS.

Under the new rules, every test site will be inspected at least five times during the growing season and two times in the following growing season. Smith said the growing season visits would be timed to cover "every critical event." She listed those events as pre-planting, planting, mid-season, harvest and post harvest. The two additional visits the following season will "ensure that regulated articles do not persist in the environment," Smith said.

For 2003 crop pharmaceutical and industrial crops, the fallow zone required around test sites will be increased to a minimum of 50 feet. In 2002, the zone requirement was 25 feet. Also, production of food or feed crops will not be allowed on the test field in the season following the production of a pharmaceutical or industrial crop. "This specific change will prevent a Prodigene [event] from recurring," Smith said.

For pharmaceutical crops, harvesters and planters will have to be dedicated to those crops only, Smith said. Tractors and tillage equipment will be subject to special cleaning requirements when moving between test crops and regular crops. Those cleaning procedures will have to be approved by APHIS in advance. Storage facilities must also be dedicated for the crop and equipment. APHIS has to pre-approve seed cleaning and drying procedures. APHIS must also pre-approve a training program so company personnel can implement all these regulations.

APHIS will regularly audit records of the company to verify compliance.

For pharmaceutical corn, current rules require that no other corn be grown within one half mile of an open pollinated test plot. The field test must be separated by 21 days, in terms of planting time, from surrounding fields. With the changes, APHIS now requires one full mile between an open pollinated test plot and other cornfields. For controlled pollination test fields, utilizing bags and de-tasseling, the distance is one half mile with a 28 day planting separation.

Also, previously rules stated border rows of non-transgenic corn could be planted to reduce isolation distances. That will no longer be allowed.

Last year 20 permits for pharmaceutical compounds were issued for 130 acres of cropland on 34 test sites. So far, Smith said there are very few applications for 2003. "Permit applicants were waiting to see what our new requirements would be," she said.

When asked why APHIS went with these tighter rules instead of restricting the geographic areas where these crops could be grown, Smith said, "We need to make sure there's complete confinement in these field tests. ... APHIS will look further at other options. ... We wouldn't rule anything out at this point." Smith expressed complete confidence in the APHIS system.

Although both Smith and Acord mentioned Prodigene, Smith said, "We were working on these changes before the Prodigene event happened." She did concede, though, that "one of the questions we asked ourselves was would this prevent a Prodigene event from happening?"

These changes are geared toward the future, Smith said. "We need to anticipate beyond this year to the eventual commercialization of this industry," she said, with more and larger field tests.

This technology holds tremendous promise for the future of agriculture," USDA Secretary Ann Veneman said. "It's important that we regulate it in a way that allows this technology to proceed so we can reap the benefits of it."

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