| Comment Record|
Mr. David Kirstein ||
2003-03-03 14:38:02 |
National By-Products, LLC |
| Comments for FDA General |
1. General Comments
NATIONAL BY-PRODUCTS, LLC
P.O. Box 615 Des Moines, Iowa 50303
Phone: (515) 288-2160, Ext. 329
Fax: (515) 288- 1007
March 3, 2003
Dockets, Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Dear Sir or Madam:
I am writing in response to Docket No. 02D-0468 and the agency’s solicitation for comments on the, “Draft Guidance For Industry on Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and Omnivores; Availability.” National By-Products is one of the major processors of animal and poultry by-products generated by the livestock, poultry and retail meat industries, as well as used cooking oils from restaurants and snack food manufacturers. Finished products — such as fats, proteins and hides — are distributed to manufacturers worldwide. In fact, NBP is the leading U.S. exporter of meat and bone meal. These finished products are used to make soaps, chemicals, cosmetics, plastics, fabric softeners, lubricants, livestock and poultry feeds, pet foods and leather goods.
NBP has also supplied frozen meat to pet food canners since the 1960s and the greyhound racing industry since the early ‘80s. With timely, efficient collection capabilities, NBP can salvage suitable meat cuts from cattle mortalities during the cooler seasons of the year. USDA veterinarians inspect these meats and NBP facilities that produce them. NBP does not distribute or sell frozen meat for direct consumption by household pets. The following comments represent National By-Products’ current thinking and recommendations regarding the draft guidance document.
The primary objective of the FDA draft guidance document appears to focus upon the protection of domestic pets and their owners from the potential food safety risks associated with the handling and feeding of frozen, inedible meats. This population segment identified by the FDA would represent, a heretofore, unknown user of these products. NBP is unaware of domestic pet owners purchasing these products and NBP would argue, based upon our experience, that such incidents are not currently occurring.
On the other hand, traditional users (pet food manufacturers, greyhound owners/trainers, mink farmers, and zoos) have safely used these products for decades. There seems to be a good understanding on the part of these individuals how to minimize any risks associated with their use. Although NBP would concur with the FDA that some risks might exist for these products, the likelihood of them causing sickness in the animals that consume them or the owners who handle them properly, appears to be remote. A paucity of historical incidents substantiates this view.
Therefore, if indeed there is an emerging market for frozen, inedible meats that NBP is unaware of, and this population is at higher risk for whatever reason, NBP offers the following suggestions:
1. Limit Access to Frozen, Inedible Meats - Require those traditional users and manufacturers of frozen, inedible meats to register with the FDA. Licensed users could be limited to the traditional customers of these products. Require manufacturers to sell only to users having an FDA license or permit number and to record this number on invoices and transportation documents. Such a system would limit the utilization of these products to experienced users who have proven themselves, while preventing their availability to domestic pets and their owners. It would also provide the FDA a means to trace the movement of these products.
2. Require Storage and Handling Instructions - Compel manufacturers to include more extensive safe storage and handling information on the label as suggested by the FDA in the draft guidance document. The information would reinforce the caution already practiced by experienced users of these products. It is also consistent with USDA labeling information required on edible meats.
3. Clarify Nutritional Representation - Require manufacturers to note on the label that frozen, inedible meats are not offered as a sole source of nutrition for the animals consuming them. NBP is unaware this has ever happened, but recognizes the potential.
Should the FDA see the need to implementation these suggestions, they should adequately meet the agency’s objective of protecting domestic pets and their owners by preventing access to these products. They would also serve to heighten the awareness of experienced users to the safe storage and handling of frozen inedible meats, as well as to their limited role in the overall nutrition plan for an animal.
Mark A. Myers, CEO & President
David Kirstein, Director of Technical Services