WASHINGTON -- The Foundation on Economic Trends, aconsumer-activist group based here, on Tuesday filed a formallegal petition with the FDA demanding that the agency rescindits guidelines on the labeling of milk produced withoutrecombinant bovine somatotropin (rBST).

The guidelines state that dairy products from cows not treatedwith rBST cannot be labeled "BST-free" since BST is a naturallyoccurring hormone in all milk. In addition, they say, " 'rBST-free' may imply a compositional difference between milk fromtreated and untreated cows rather than a difference in the waythe milk is produced." (See BioWorld, Feb. 9).

The foundation, headed by biotechnology gadfly Jeremy Rifkin,accused FDA of "gross violations of federal conflict-of-interestlaws" in drafting the guidelines and called for an investigationby the inspector general of the Department of Health andHuman Services (HHS) and Congress. FDA's deputycommissioner for policy, Michael Taylor, who the foundationalleges wrote FDA's bovine growth hormone labeling guidelines,formerly represented bovine growth hormone manufacturerMonsanto Agricultural Co. as a lawyer at the Washington, D.C.,law firm King and Spalding.

The BST guidelines could be seen as advantageous to Monsantosince they limit advertising by companies that wish tocapitalize on a "BST-free" label.

The foundation is also protesting April 1992 FDA guidelinesthat do not require special labeling of biotechnology-derivedproduce. The group alleges that Taylor supervised the draftingof these guidelines. The law firm King and Spalding alsorepresented a group of biotechnology companies, includingCalgene Inc., while Taylor was on staff.

Andrew Kimbrell, a spokesman for the Pure Food Campaign, anarm of the Foundation on Economic Trends, said Taylor'sinvolvement in drafting the guidelines violated federal ethicslaws because it "created the appearance of partiality orfavoritism" due to Taylor's previous ties with Monsanto. "Itshows a shocking lack of ethics and judgment on the part of(FDA Commissioner David) Kessler," said Kimbrell. Rifkin calledTaylor's involvement in shaping FDA policy on bovine growthhormone a "cynical betrayal of the public trust."

FDA, however, said Taylor removed himself from working onissues relating to bovine growth hormone for more than a yearafter he left the law firm in July 1991 to take a position withthe FDA, according to Jack Kress, special counsel for ethics inthe Department of Health and Human Services. Furthermore,Taylor did not, in fact, write the guidelines, but was part of anFDA committee that drafted the guidelines by consensus, Kresssaid.

According to Kress, ethics laws require that federal employeesrefrain from working directly on projects affecting formeremployers or clients for a year after leaving private industry;Taylor did not participate in FDA committee work on BST untillast December.

An official response is required to the foundation's legalpetition, which was addressed to Kessler and HHS InspectorGeneral June Gibbs Brown. The petition could be a precursor toa lawsuit if certain legal conditions are met.

Meanwhile, Monsanto Agricultural Co. of St. Louis, Mo., beganselling BST on Feb. 4, when a 90-day moratorium on sales ofthe product lapsed. The moratorium was imposed after the FDAapproved the product last Nov. 5. According to Monsantospokesman Tom McDermott, the moratorium was included as alast-minute amendment to the 1994 budget in Congress.

McDermott said it was the first time Congress has delayed themarket introduction of an FDA-approved product. He addedthat in the three weeks since its market debut, BST hasgarnered several thousand customers in 46 states and thatseveral hundred thousand cows have already been treatedwith BST.

-- Lisa Piercey Washington Editor

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