Center for Veterinary Medicine - U S Food and Drug ...

Center for Veterinary Medicine

Fiscal Year 2007

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Chapter 5 ? Center for Veterinary Medicine

Contents

Animal Feed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 Animal Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8 BSE Enforcement Activities . . . . . . . . . . . . . . . . . . . . . 5-12 Illegal Drug Residues . . . . . . . . . . . . . . . . . . . . . . . . 5-13 Pet Turtle Warnings . . . . . . . . . . . . . . . . . . . . . . 5-18 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19 Enforcement Actions . . . . . . . . . . . . . . . . . . . . . . . . . 5-21

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Animal Feed

Menu Pet Food Recall _______________________________________________________

FDA Tackles One of the Largest Pet Food Recalls in History

In March of 2007, a massive recall of pet food products manufactured by Menu Foods, Inc., a private-label pet food

manufacturer based in Streetsville, Ontario, Canada, was initiated. On March 16, 2007, Menu Foods announced that it was recalling all its "cuts and gravy" style dog and cat food produced at its facility in Emporia, Kansas, between December 3, 2006, and March 6, 2007.

The recall was prompted by consumer complaints received by Menu Foods of kidney failure in a number of cats and dogs. Menu Foods began conducting its own tasting trials and reported instances of kidney failure after the animals ate the affected product. As of March 17, 2007, Menu Foods reported 14 animal deaths to the FDA. Nine cats died during routine taste trials conducted by Menu Foods. The products involved in the recall were sold in the United States, Canada and Mexico.

FDA consumer complaint coordinators nationwide began receiving calls from consumers and veterinarians who reported illnesses potentially associated with the contaminated pet food. In the first three weeks of the recall, FDA received over 12,000 reports--more than twice the number of complaints typically received in a year by the consumer complaint coordinators.

Initially, the recall was limited to "cuts and gravy" style pet food in cans and pouches of dog and cat food Menu Foods manufactured between December 3, 2006, and March 6, 2007.

Recalled pet foods later included cat, dog, and ferret foods. A complete list of pet foods affected by the recall is available on a website at: . The foods are listed by type of pet food and then alphabetically.

Finding the Cause

In March 2007, FDA learned that certain pet foods were sickening and killing cats and dogs. Analysis by the Agency's Forensic Chemistry Center revealed melamine and melamine analogues in the pet foods and in the wheat gluten used as an ingredient. After FDA traced the suspect wheat gluten to a single supplier in ________________________________________________________________________

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China, the Agency issued an Import Alert focused on this firm and began sampling 100 percent of all wheat gluten from China. In April 2007, FDA launched an investigation into imported rice protein concentrate that also was used as an ingredient in some pet foods and was found to contain melamine and its analogues. The Agency traced the suspect product to another Chinese supplier. FDA issued an Import Alert focused on this supplier and began sampling 100 percent of all rice protein concentrate from China.

Melamine is a molecule that has a number of industrial uses, including use in manufacturing cooking utensils. It has not been approved for use as an ingredient in human or animal food in the U.S, and it is not permitted to be used as fertilizer in the U.S., as it is in some parts of the world.

Ultimately, Import Alert #99-29 was issued on April 27, 2007, to expand on the previous alerts to cover all vegetable protein products from China. Under the Import Alert, FDA can refuse admission of these products unless third party analysis or other evidence demonstrates they are not contaminated with melamine or its analogues. To read the full text of this Import Alert, go to: .

During the investigations that traced the distribution of contaminated pet food, it was discovered that byproducts (or scraps) from the manufacture of this pet food were distributed to farms in a limited number of states and added to the feed consumed by swine and poultry. A panel of scientists from five Federal agencies determined that consuming food from the animals that ate the tainted feed was unlikely to pose a significant risk to human health, due to the small amounts of contaminant present and the small amounts that would be consumed.

The full text of the safety assessment of melamine in foods in available online at: .

Castleberry's Dog Food Recall _______________________________________

Castleberry's Food Products - Including Canned Dog Food - Found Contaminated with Clostridium botulinum

On July 19, 2007, Castleberry's Food Company ("Castleberry's"), Augusta, Georgia, owned by Bumble Bee Foods, LLC,

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recalled multiple food products -- including canned dog food -- due to possible contamination with the bacteria Clostridium botulinum, known to cause botulism.

Subsequently, on July 21, 2007, "Castleberry's" voluntarily expanded its July 19th recall of canned meat products due to possible contamination with Clostridium botulinum after information gathered by FDA and U.S. Department of

Agriculture (USDA)/Food Safety Inspection Service (FSIS) indicated that

processing malfunctions at the establishment existed longer than initially

estimated.

For that reason, "Castleberry's" agreed to expand its recall of all products that still might be in commerce, regardless of the "best buy" date stamped on the bottom of the can. A complete list of all products subject to recall can be found on the USDA's website at: . asp. Products include both products for human consumption such as beef stew, chili, hot dog chili sauce, etc., and pet food products.

Dog foods subject to recall included the following products:

? Irish Stew Natural Balance Eatables for Dogs; ? Chinese Take Out with Sauce with Vegetables & Chicken Natural Balance

Eatables for Dogs; ? Southern Style Dumplings with Gravy with Chicken & Vegetables Natural

Balance Eatables for Dogs; and, ? Hobo Chili with Chicken Pasta Natural Balance Eatables for Dogs.

Consumers who had any of these products or any foods made with these products were advised to throw them away immediately. Consumers were instructed to double bag the cans in plastic bags that are tightly closed, then to place them in a trash receptacle for non-recyclable trash outside of the home. Additional instructions for safe disposal can be found at: botulism/botulism_faq.htm.

Salmonella in Dry Dog Food Recall ____________________________________

CDC Reported 64 Cases of Human Illnesses Traced to Contaminated Dog Food

On August 25, 2007, FDA alerted consumers that Mars Petcare US, Inc., was recalling two dry dog food products because of the potential that

the product was contaminated with Salmonella Schwarzengrund.

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Mars Petcare US, based in Franklin, Tennessee, voluntarily recalled five-pound bags of Krasdale Gravy dry dog food sold in Connecticut, Massachusetts, New Jersey, New York, and Pennsylvania, and 50-pound bags of Red Flannel Large Breed Adult Formula dry food sold in Pennsylvania.

Salmonella can potentially be transferred to people handling pet food, especially if they have not thoroughly washed their hands after having contact with the product or any surfaces exposed to the product. As of August 25th, there had been 64 cases of illness in humans related to Salmonella Schwarzengrund reported to the U.S. Centers for Disease Control and Prevention (CDC). However, none of the reported cases were directly linked to the recalled product that was tested. FDA worked with local and state officials, and with officials at the CDC in the investigation.

To view the full text of FDA's Press Release related to this recall , go to: .

Warning - Cat Food With Salmonella __________________________________

On February 13, 2007, FDA issued a warning to consumers not to purchase, or use, Wild Kitty Cat Food due to the presence of Salmonella, a pathogen. During routine monitoring activities, FDA collected and analyzed a sample of frozen raw Wild Kitty Cat Food and detected Salmonella in the product. Cats and other pets consuming this food may become infected with Salmonella. People can also become infected with Salmonella if they handle or ingest this cat food, touch pets that consumed the food, or touch any surfaces that came into contact with the food or pets.

The specific products covered by this warning were Wild Kitty Raw All Natural, Frozen Cat Food ? Chicken with Clam Recipe, Net Wt. 3.5 ounce (100g) and 1 pound in plastic containers; Raw Duck with Clam Recipe, Net Wt. 3.5 ounce (100g) and Net Wt. 16 ounce (453.6g); and Raw Tuna with Conch Recipe 3.5 ounce (100g) all lot codes.

The Wild Kitty Cat Food was sold nationwide to retail stores and through distributors and internet sales, nationwide. The manufacturer declined to recall this product despite several requests by FDA that it do so.

FDA advised that consumers who purchased this product should not feed it to their pets, but should instead dispose of it in a safe manner (e.g., in a securely covered trash receptacle). Anyone who experienced the symptoms of Salmonella

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