FDA, Poultry Industry At Odds
Over Anti-Bacteria Products

WASHINGTON —(AP)— Can bacteria make meat safer? Scientists say the answer is yes — by using good bacteria to drive out bad bacteria from the guts of food animals.

To biologists, the process is known as competitive exclusion.

The Food and Drug Administration, however, is not quite so sure that two bacteria products designed to reduce the incidence of salmonella in chickens are harmless. The agency is blocking their introduction on grounds that in dealing with one health problem the industry could be creating another one that is as bad or worse.

Some of the bacteria the products contain could be resistant to antibiotics; the FDA fears that could lead to humans contracting diseases that drugs cannot treat.

``We want to make sure we're not introducing resistant organisms into the chickens inadvertently'' said Steve Sundlof, director of the FDA's Center for Veterinary Medicine.

The anti-salmonella treatments contain many different types of bacteria, some of which scientists cannot identify, and that is what concerns the FDA.

Although salmonella is a leading cause of food poisoning, public health officials also are worried that an antibiotic-resistant bacteria could render penicillin and other infection-fighting drugs ineffective in humans.

Congress has joined the poultry industry in urging quick FDA approval of the anti-salmonella treatments, one of which was developed by Agriculture Department scientists.

Legislation signed into law by President Clinton last month calls for the FDA to do an ``expedited review'' of the two products. That would move them ahead of the line of animal drugs now under consideration at the agency.

``There's a lot of interest in these products. We're anxiously waiting,'' said Richard Lobb, a spokesman for the National Chicken Council. Salmonella ``is a declining problem but it is still a concern.''

Supporters of the two products say the standard the FDA is setting is too high and too vague, and threatens the development of other bacterial treatments. Similar products are being studied as a way to eliminate a deadly pathogen, E. coli O157:H7, from cattle.

``It's slowed me down,'' said Norman Stern, one of the Agriculture Department scientists who developed the anti-salmonella product. ``I'm looking for alternatives.''

The FDA has ``made a mountain out of a molehill and denied consumers access to these products,'' said John Keeling, vice president of legislative affairs for the Animal Health Institute, which represents drug manufacturers.

The FDA announced in 1998 that it was going to regulate the products as drugs. That forced Bayer Corp. to withdraw its anti-salmonella product from the market until it could get FDA approval and blocked the Agriculture Department-developed product from going into use in the United States.

The FDA did approve a third product after being satisfied it posed no safety hazard, but industry sources say it is harder to use and more limited in application.

The Agriculture Department's product is licensed to a private company, a subsidiary of the former Continental Grain Co., and was submitted to the FDA for approval in 1996.

The bacteria it contains are scraped from the intestinal tracts of chickens known to be free from salmonella and other pathogens, and then multiplied through a fermentation process. The product is applied to young chicks through a spray.

The product, currently in use in Brazil and Japan, can reduce the incidence of salmonella by as much as half or more, according to research published earlier this year in the Journal of Food Protection.

The problem its supporters have in getting FDA approval is that there are 10 billion bacteria per gram of the product, representing at least 65 different species. While it is virtually impossible to know every type of bacteria in the product, the product's developers say they are convinced it poses no danger to chickens or humans.

A consumer advocacy group, Food Animal Concerns Trust, supports competitive exclusion research but says the FDA is right in scrutinizing the products.

``FDA needs to give sufficient time to the question to make sure that consumers are protected and that the breakfast table is a safe place to eat,'' said Richard Wood, executive director of the group, which operates a series of poultry research farms. ``Once products are approved it's very difficult to remove them from the market.''