If majority rule determined how seriously governmentagencies take public comment on their notices in the FederalRegister (FR), then Calgene's petition to the U.S. Dept. ofAgriculture for permission to market its herbicide-tolerantcotton would win by 29 votes to nine.

The company filed its 96-page petition with USDA on July 14(see BioWorld, July 16). A summary of its claims appeared inthe FR on Sept. 8. It invited public comments "on whether suchcotton presents a plant pest risk."

The announcement described Calgene's transgenic BXNcottonseed as containing the bnx gene, transferred from thebacterium Klebsiella pneumoniae subsp. ozaenae, whichencodes an enzyme, nitrilase, that degrades the broad-leafherbicide bromoxynil. The cotton also carries transfected vectorand promoter from Agrobacterium tumefaciens; terminatorsequences from cauliflower mosaic virus. All three of theseDNA donors are plant pesticides under the law.

But USDA's Animal and Plant Health Inspection Service(APHIS), the FR notice added, "In the process of reviewing 15field trials with BXN cotton, determined that the vectors andother elements were disarmed, and that the trials did notpresent a risk of plant pest introduction or dissemination."

By Nov. 8, the 60-day deadline for public comment, most of the38 opinions had reached the desk of Shirley Ingebrittsen, whodescribes herself as "USDA's comment person." She toldBioWorld that the poll presented no surprises. Most of the 29respondents who supported granting Calgene's petition arecommissioners of agriculture, farm bureau and cotton-growerassociations, and university scientists familiar with the tests.Those opposed were primarily members of the EnvironmentalDefense Fund, the Sierra Club/National Coalition Against theMisuse of Pesticides and the Union of Concerned Scientists.

These consumer activist organizations advanced essentiallysimilar arguments for denying Calgene exemption from USDA'splant pesticide control regulations.

Among the most forthright was Rebecca Goldburg, seniorscientist at the Environmental Defense Fund. She wrote: "(1)Calgene relies on poor logic and inadequate information anddata to substantiate its claim that gene transfer from BXNcotton to wild cotton does not pose a plant pest risk, and I thusdo(es) not provide the solid support APHIS should requirebefore exempting almost certainly forever a geneticallyengineered crop from further regulation by APHIS; (2)Calgene's petition blatantly misrepresents significant humanhealth and ecological hazards associated with the increased useof bromoxynil. I Indeed, Calgene has developed BXN cottonexpressly to increase the use of bromoxynil. I"

She added: "This goal appears even to be the primarycommercial purpose for the joint venture between Calgene andRhone Poulenc, the manufacturer of bromoxynil."

To which John Callahan, Calgene's senior vice president forcotton, retorted: "We're not interested in spending more onherbicidal chemicals and neither are the cotton growers. Now,Rhone Poulenc PP yes. They will do it at the expense of thepeople who sell the arsenic and other weed-killing compoundswe think we can displace."

He explained that the French chemical giant manufacturesbromoxynil under the trademark Buctril, but that at presentthis herbicide cannot benefit cotton growers because it kills thecotton plants along with the noxious weeds. Calgene'sbromoxynil-tolerant transgenic plants would permit low-doseBuctril to replace three or more herbicides now applied in highvolume and expense.

"Currently, cotton growers use around 20 million pounds a yearof herbicide, Callahan told BioWorld, "which cost them $197million in 1992 and over $300 million this year.

"Even our critics I who asked USDA to deny approval to BXNcotton, missed the three herbicides we're targeting," he added."They overestimated Buctril's potential use on cotton by afactor of two or three. No way in hell is BXN cotton going tolead to millions of pounds of Buctril. We're talking about four tosix ounces an acre, substituting for seven, eight, nine poundsper acre of those other herbicides."

Callahan explained that besides USDA, which has promised itsdecision by mid-January 1994, Calgene is awaiting licensing bythe EPA and concurrence by the FDA according to its guidelinesfor genetically engineered foods. Assuming these permissionsall come through, Callahan said, "we will be doing a limitedmarket introduction of BNX cotton in 1994, for which we nowhave enough seed stockpiled. In 1995, this would scale up 10-fold, and the third year we would no longer be seed-constrained but market-constrained."

Jane Rissler, senior staff scientist at the Union of ConcernedScientists, decried extending the market for bromoxynil, whichshe denounced as "a reproductive toxicant and environmentalpoison," under current scrutiny by EPA. Her statement citedbirth defects Buctril caused in laboratory animals and itsextreme toxicity to freshwater fish.

Callahan riposted that the safety issue should be addressed toEPA, not to USDA's notice in the FR. "Rhone Poulenc is managingthe issue with EPA, which will do what it does with any otherherbicide: Is it safe for use in accordance with the label?" Headded that EPA continues to review and re-review Buctril,which he said has a 25-year record of safe use in many othercrops.

When Calgene's anti-BNX cotton critics look through thecomments from 29 supporters of the plant, they will be struckby the identical phraseology in at least 13 of the favorableletters to the USDA. This supporter majority includes FarmBureau Federations and similar groups from half a dozen of themain cotton-growing states, state agriculture departments fromall 10, a clutch of university cotton agronomists and theNational Cotton Council of America.

The apparent form letters follow a pattern beginning, "Thisletter is in support of Calgene's petition for non-regulatedstatus for BNX cotton. This cotton does not present a plant pestrisk and should no longer be considered a regulated article."The comments then continue to state verbatim Calgene'sprincipal claims and arguments.

Callahan neither denies nor confirms that his companygenerated this pro forma favorable response. "We notifiedthem of what we thought were the key issues that USDA laidout, namely: Does this cotton perform differently in the field?What's your general assessment of its importance to the cottonindustry? We told them we'd welcome their comments. Someused our phraseology, but they all put their professionalreputation on the line."

He also noted that the negative responses share a similarity ofarguments and wording. "What's interesting to me," he said, "isthat there was hardly a groundswell of concern. Whensaccharine goes up for review, 20,000 comments pour in. OurFlavrSavr tomato drew 2,000 responses PP the vast majoritypositive.

"We got 29 positives from guys aware of our BNX cotton fieldtrials. Now USDA must decide, factoring in public comments tothe extent they can," he said. "Hopefully, they'll get down to thescience, not the politics."

-- David N. Leff Science Editor

(c) 1997 American Health Consultants. All rights reserved.