U.S. to disclose more information about pharm crops

June 3, 2004 -- CropChoice news -- Andrew Pollack, NY Times, 06/02/04: Responding to criticism that a controversial farming practice is shrouded in secrecy, the Department of Agriculture plans to disclose more information about crops that are genetically engineered to produce pharmaceuticals, an official said yesterday.

The official, Cindy Smith, the deputy administrator for biotechnology regulatory services, said in an interview that the department planned to begin using its Web site to post its analysis of the risks and environmental impacts of the crops that are being grown in field trials.

"We do agree that more transparency would reassure the public and the stakeholders," Ms. Smith said. "We want to be more transparent in advance of this technology really scaling up."

Biotechnology companies say that genetically modified crops could be a way to produce certain pharmaceuticals inexpensively.

Food companies and environmental groups, however, have objected, particularly to the use of food crops for this purpose. A commonly expressed fear is that drugs might inadvertently end up in somebody's corn flakes.

Critics have also complained about the lack of information about the field trials and the lack of public discussion before permits are granted.

The Department of Agriculture makes some information about field trials available. But it usually leaves out what pharmaceutical is being produced, the acreage involved, and the location other than the state, because such data are usually classified as confidential business information by the company conducting the trial.

The new policy seems likely to mollify critics, although not completely. It would allow the public to comment before a permit is issued for field trials deemed large or risky enough to require a formal environmental assessment. But there would be no comment period, Ms. Smith said, for smaller, more routine trials that receive a more abbreviated risk assessment.

The Agriculture Department would still not disclose information that companies consider confidential, she said.

The new policy comes as the number of such field trials is on the rise after a hiatus.

Companies applied for 13 permits and public research institutions for three, in the 12 months that ended in April, according to a report being issued today by the Center for Science in the Public Interest, a consumer group.

That came after a sharp decline in trials that occurred after incidents in 2002 in which corn containing a pig vaccine became intermingled with food crops, even though the authorities said the problems were caught before any such food was eaten.

The company involved in those incidents, ProdiGene, was fined, regulations were toughened and applications for field trials slowed.

From July 2002 to June 2003, the government approved only four trials, down from 25 in the previous year, according to the consumer group's report, which used data from the Web site listing trials of genetically engineered crops.

The report said that 11 of the 16 applications involved a food crop and the rest tobacco. Six applications were to grow corn in Iowa, Nebraska or Texas, states that produce large amounts of corn for food and feed.

Some companies, including ProdiGene, are already selling products made in genetically modified crops grown in the trials, the report said.

ProdiGene applied for four permits in the last year, according to the report. Other applicants included Large Scale Biology, Chlorogen and SemBioSys.

Ms. Smith said that field trial activity is still not back to the level it was before the ProdiGene incidents. Many field trials being applied for now are very small, she said.


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