May 20, 2004
FDA Issues Final Guidance on Raw Meat for Animals
FDA has released final Guidance for Industry entitled, “Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and Omnivores” (GFI #122) FDA developed the guidance in response to the increasing trend in the use of raw meat animal feeds. If the raw meat is not properly handled, bacteria present on the meat can make people and animals ill, and can contaminate home environments. CVM issued the guidance to industry to better protect animals and their owners. FDA released the draft guidance on this subject in December 2002.
The final guidance contains recommendations proposed in the draft guidance, including:
Manufacturers who produce raw meat diets should use USDA/Food Safety and Inspection Service (FSIS)-inspected meat that has been passed for human consumption.
Manufacturers should use measures to prevent bacterial contamination of the meat. The measures manufacturers can use i nc lude irradiation, participation in USDA's voluntary inspection program, and use of good manufacturing practices such as those used for human foods.
Manufacturers could also develop and implement Hazard Analysis and Critical Control Point programs, which are processes designed to discover the likely source of contamination and take action at those points to prevent problems.
When shipping the raw meat diets that are not freeze-dried, manufacturers should ensure the diet is kept frozen at all times.
Bones used in raw meat pet products should be ground so they will not cause trauma in the animal.
In addition to labels containing all components required by Federal and State statutes and regulations, the guida nc e recommends the label contain a section titled Guidelines for Safe Use that informs the reader to:
Keep the product frozen until ready to use
Thaw the product in the refrigerator or microwave
Keep the product separate from other foods. Wash working surfaces, utensils (including cutting boards, preparation and feeding bowls), hands, and any other items that touch or contact the product with hot soapy water.
Refrigerate leftover product immediately or discard.
The guidance document also states that FDA has not seen any objective evidence to suggest that raw meat diets are better than other kinds of diets.
Final Guidance for Industry #122 is posted on the FDA/Center for Veterinary Medicine Home Page. Single copies of the draft guidance may be obtained by writing to the Communications Staff, FDA/Center for Veterinary Medicine, 7519 Standish Place, HFV-12, Rockville, MD 20855, 301-827-3800. Please send one self-addressed adhesive label to assist in processing your request.
Additional information about the guidance is included in the May 20, 2004 , Federal Register . Questions about the guida nc e may be directed to: Dr. William J. Burkholder, Division of Animal Feeds, (HFV-228), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-0179 (e-mail: mailto:William.Burkholder@fda.gov).
This final guidance represents the Agency's current thinking on these products. It does not create or confer any rights for or on any person and does not operate to bind the FDA or the public. An alternate approach may be used as long as it satisfies the requirements of applicable statutes and regulations.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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