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News Release

CountryDateRelease Date

United States

July 15 1998

July 20 1998

FDA claims milk safe, evades farm magazine editor's questions

But FDA opens up after call to milk industry lobbyist

Last month a Food and Drug Administration official responsible for milk safety inexplicably avoided milk safety questions from a farm publication's editor. In June 1997, Kurt Gutknecht, editor of the highly respected farm publication Wisconsin Agriculturist, preparing an article on milk safety for the July issue, called Joseph M. Smucker of the FDA to question him about an FDA position regarding safety of commercial pasteurization. Smucker refused to talk to him. Despite being the team leader of the milk safety team, Smucker asserted that he did "not have the expertise nor the clearance from the FDA to speak to you on this subject."

The subject that Smucker wouldn't discuss was an official FDA position that stated "conclusively that commercial pasteurization eliminates the hazard" of contamination of the nation's milk supply with Mycobacterium avium subspecies paratuberculosis(MAP). This organism causes a serious inflammatory bowel disease in cattle and is suspected of causing a similar disease, Crohn's disease, in humans.

"I was surprised at Mr. Smucker's reluctance to talk to me," commented Gutknecht.

Stephanie Bernier, a spokesperson for the FDA, said it is "very unusual" for an official of the FDA to avoid responding directly to press inquiries.

"No FDA official concerned with milk safety responded to our inquiries," said Gutknecht. "Calls to the FDA's press office were returned only after we contacted John Adams, director of milk safety and animal health for the National Milk Producers Federation." The National Milk Producers Federation is a registered lobbying organization representing dairy industry interests in Washington.

Previously, Smucker had no hesitation about openly stating the FDA's position on MAP contamination of milk. In February 1998, in a letter to milk industry insiders and others, Smucker stated flatly, "After a review of the available literature on the subject, it is the position of the FDA that the latest research shows conclusively that commercial pasteurization does indeed eliminate this hazard."

Stephen Merkel, board member of Paratuberculosis Awareness and Research Association, Inc., a nonprofit organization dedicated to the prevention and cure of Crohn's disease, commented, "I think that the FDA has stepped over the line. Not one study supports their position that commercial pasteurization eliminates MAP as a hazard in milk. They claim to have reviewed the available literature on the subject. Really? Most studies conclude that commercial pasteurization allows a small percentage of MAP to remain viable. Even the study that the milk industry loves, one that was done by the USDA, doesn't give a blanket endorsement to commercial pasteurization. Such a dubious basis for the FDA position could explain their sudden allergic reaction to the press. But why did a phone call from a farm magazine to a milk industry lobbyist change their mind? Is the milk industry calling the shots at the FDA?"

The USDA study that Merkel referred to, published in December of 1997, was one of many both here and abroad seeking to determine if MAP could survive pasteurization. Contrary to all of the other studies, the USDA study alleged that no organisms survived a trip through a laboratory-scale-model pasteurizer. Yet the study cautiously concluded, "Results from these studies indicate that transmission of viable M. paratuberculosis from animals to humans via pasteurized dairy products is unlikely and minimize the potential threat of this organism as a zoonotic agent of Crohn's disease." -in contrast with the FDA's sweeping position statement.

Scientists perform pasteurization studies because MAP is suspected of being an infectious agent causing Crohn's disease, a debilitating human intestinal disease characterized by inflammation, abdominal pain, diarrhea, rapid weight loss and even death-symptoms remarkably similar to those of MAP infection in cattle. Diseased cows shed the bacteria in their feces and in their milk. If the organism survives pasteurization, it has the opportunity to infect humans.

Researchers and others are questioning the FDA's motives for their position on pasteurization and MAP. "The FDA response reads more like a political response than a scientific assessment," commented Michael Collins, president of the International Association for Paratuberculosis, Inc., microbiologist and veterinarian with the University of Wisconsin School of Veterinary Medicine.

Karen Meyer, mother of a Crohn's patient and founder of Paratuberculosis Awareness and Research Association, Inc., said of the FDA, "Their own mission statement says that they are responsible for ensuring that foods are safe, wholesome and sanitary. That regulated products are honestly, accurately and informatively represented. That these products are in compliance with the law and FDA regulations; noncompliance is identified and corrected; and any unsafe or unlawful products are removed from the marketplace.' That's what they say. I believe that in the case of possible MAP contamination of milk that they have failed on every count to live up to their own mission statement. Twenty percent of herds in the United States are infected with MAP. There are 400,000 Crohn's suffers in the United States now and 20,000 new cases every year, mostly young people. It's a 3.3 billion dollar a year national tragedy. How many more victims of Crohn's disease do we need before the FDA stops defending the industry they are supposed to regulate and starts acting in the interest of the public? These laboratory studies are bunk. The only way we are going to know if milk is safe it to test retail milk."

For further information contact

ContactKaren Meyer
Executive Director, Paratuberculosis Awareness and Research Association, Inc.

Paratuberculosis Awareness and Research Association, Inc.

is a non-profit organization of Crohn's disease patients, their families and friends who are dedicated to the following goals:
  1. To raise awareness of the zoonotic (disease-causing) potential of the bacterium, MAP, in the national community of sufferers of Crohn's disease, in medical, veterinary and food science research communities, in governmental agencies and in the public in general
  2. To urge governmental agencies to directly address control and eventual eradication of MAP from the human environment, particularly from foods of animal origin
  3. To urge governmental and medical research agencies to make funding available for research which will determine the role played by MAP in causing Crohn's disease

Paratuberculosis Awareness and Research Association, Inc.
Box 16219
Temple Terrace, FL 33687-6219

Source:   Contact PARA:
Paratuberculosis Awareness & Research Association