Docket Management
Docket: 02D-0468 - Draft Guidance-Manufacture& Labeling-Raw Meat Foods-Carnivores&Omnivores
Comment Number: EC -18

Accepted - Volume 1

Comment Record
Commentor Dr. Jean Hofve Date/Time 2003-03-02 16:15:31
Organization Little Big Cat, Inc.
Category Health Professional

Comments for FDA General
1. General Comments Dockets Management Branch (HFA 305) Food and Drug Administration 5600 Fishers Lane, Room 1061 Rockville, MD 20852 Docket: 02D-0468 - Draft Guidance-Manufacture& Labeling-Raw Meat Foods-Carnivores&Omnivores Dear Sir/Madam: I would like to submit the following comments concerning the Draft Guidance on Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and Omnivores. Raw meat diets have been fed to working and racing sled dogs, racing greyhounds, and captive noncompanion animals (big cats, wolves, bears, etc.) in zoos, rescue facilities, and wildlife parks for many years. Most of the time, these diets have comprised so-called “4D” meats that have been condemned for human consumption. The first raw meat diets for companion animals were also made from 4D, feed grade, and other questionable source meats and by-products. (Some apparently still are; Breeders Choice and Animal Food Services reportedly use meats and by-products condemned for human use in some of their raw meat diets). As a holistic veterinarian who advocates raw meat diets for some companion animals, I am glad to see CVM taking a position in this matter. Raw meat diets are very popular among dog and cat breeders, fanciers, and ordinary pet guardians. Not long ago, Dr. David Dzanis predicted that if raw meat diets become popular enough, major pet food manufacturers are certain to introduce their own versions to take advantage of the market. I agree that is only a matter of time until we see Hill’s, Iams, and other manufacturers jump into the fray. Hill’s, at least, has already conducted tests on such diets. It is timely and appropriate for CVM to issue guidance on the manufacture of these diets. Given the problems with processed pet food, it is quite understandable that consumers might look for other options for feeding their dogs and cats. Many people prepare their pets’ food at home from human-grade ingredients that they buy at the grocery or health food store. Many consumers would like to feed a raw diet, but have limitations of time or accessibility that prevent them from making their pets’ food. Good-quality, safe, raw meat diets fill an important void in pet feeding options. In general, I support the findings and proposed rules that CVM has proposed for raw meat diets for pets. However, I take issue with a few minor points. My comments are directed primarily to diets for companion carnivores (cats) and omnivores (dogs). No one who advocates raw diets for pets advocates forsaking ordinary safe meat handling procedures. I believe the risks to humans from feeding raw meat diets in the home are vastly exaggerated. If consumers follow standard safe meat handling procedures, the risks are likely no higher than from preparing meat dishes for the human family members. I would like to point out that one of the references relied upon by CVM in preparing the draft guidance, Freeman & Michel (2001), was a badly flawed study that failed to truthfully report all the results obtained. They made much of finding Salmonella contamination in one of the diets. What they did not say is that the dog eating the diet never developed any symptoms of Salmonellosis. I wrote a critique of this study, “Bad Science,” Whole Dog Journal, July 2001;4(7):12-13) that fully exposes the numerous problems with that study. In fact, the quality and relevance of the references selected to support the guidance document are not very good. For instance, the document cites studies conducted outside the U.S. (Nyeleti et al., 2000; Atanassova et al., 2001, deAssis et al. 2000)). I doubt the data from such studies would have much—if any—bearing on livestock and food handling practices here in the U.S. The anecdotal report of hypervitaminosis A in a cat (Goldman, 1992) is not only outdated, but not at all applicable to the balanced commercial diets that this draft guidance seeks to address. The article by Dr. Machlik (1999) is primarily an opinion piece, and it should be noted that she was and is employed by a major U.S. pet food manufacturer, so this article cannot be regarded as completely unbiased. There are certainly abundant data on contamination and other problems in the domestic livestock and meat-packing industries that would have been more pertinent and supported CVM’s position better. Certainly raw meat diets for companion animals may be contaminated with any number of pathogenic organisms. As stated in the draft guidance, this is true for products made from meat products passed by USDA for human consumption as well as condemned materials. Bacterial contamination in the human food supply is well-documented. However, it appears that dogs and cats are relatively resistant to bacteria commonly found in meat and meat products. There are very few reports of illness from food-borne pathogens in dogs and cats, in spite of the thousands of pets eating raw diets. Documented accounts of illness and death from processed commercial pet food are more common, as evidenced by the recalls of fungal-contaminated pet food by Nature’s Recipe and Doane’s in the 1990s, which sickened or killed dozens of dogs. Unpublished data from the University of California at Davis documents the high incidence of surface contamination of dry dog food with potential pathogens. Moreover, bacterial endotoxin was also found in virtually all dog food samples, indicating significant bacterial contamination of ingredients prior to processing. While the bacteria themselves were killed in the manufacturing process, endotoxin was not affected. Whether and how this endotoxin affects animals eating the food is unknown, but the researcher suspects that many cases of gastroenteritis in dogs of unknown etiology (often referred to as “garbage gut”) are actually due to contamination of regular commercial dog food. I agree with CVM’s assessment of the risk of unground bone in raw meat diets for pets. Many holistic veterinarians have reassessed the wisdom of the “raw meaty bones” concept, after seeing bowel perforations and broken teeth due to whole raw bones, and are now recommending that bone be ground before feeding. I agree that this is the best approach. I am a little concerned with the manufacturing section. Clearly, following GMPs is highly desirable. However, I am not convinced of the value of the HAACP program’s ability to prevent or control contamination in the human food industry. There have been many instances where HAACP has resulted in poorer sanitation and inspection standards than previous inspection programs. I am also opposed to food irradiation instead of adequate sanitation procedures for controlling contamination. If irradiation is used in the making of raw meat diets, I strongly believe that this should be indicated on the label. Consumers should be provided the necessary information to allow them to voluntarily feed or not feed irradiated food to their pets. I support requiring safe handling instructions on raw meat pet diets, similar to those required by USDA on meat sold for human consumption. The labeling suggested in the guidance document (Section III.2.a.) is reasonable and appropriate. I also agree that raw diets should be brought under the aegis of the AAFCO model regulations, as suggested in the guidance document (Section III.2.b.). Consumers are familiar with the labeling and nutritional adequacy statements used for processed commercial pet foods; raw meat diets should not be any different. The limitations on claims made for raw meat diets (Section III.2.c.) are also reasonable. Thank you for your consideration of these comments. Sincerely, Jean Hofve, DVM

EC -18