| May 12, 2006 Docket Clerk US Department of Agriculture Food Safety and Inspection Service 300 12th Street, SW, Room 102 Cotton Annex Washington, DC 20250 RE: FSIS NOTICE NO. 15-06 Use of Non-Amenable Animal Tissue in Inspected Products The Association of Food and Drug Officials (AFDO) appreciates the opportunity to present the following questions regarding the recently issued FSIS NOTICE No. 15-06 Use of Non-Amenable Animal Tissue in Inspected Product. Our collective questions are as follows: - Many states have laws restricting the sale for food of certain wild game, including deer meat. Has FSIS considered the impact on these states if it permits such wild game ingredients to be used essentially without restriction in FSIS-inspected product? This concerns such products produced in any FSIS-inspected plant, because Federally-inspected product may be distributed in any state, including states where selling such product now is illegal. In sum, the proposed federal policy of administratively allowing federally inspected product to contain essentially non-regulated animal products as an ingredient effectively preempts state laws restricting food uses of those animal products. Is this FSIS’ intent?
- Is it not true that this policy would permit non-amenable meat and poultry ingredients to be used in an FSIS-inspected product up to 97 percent of the weight of the product? In such a case, does not the FSIS mark of inspection on the product imply that these species are amenable? Why would it not be misleading to consumers for a product consisting of 97% non-inspected animal tissue to bear a Federal mark of inspection?
- Almost all food, with the exception of raw fruits and vegetables, require state inspection and/or licensing to legally sell their product within the state and certainly across state boundaries. Given that FSIS is saying that it intends not to regulate these ingredients, might it revise/reword the policy to state that all non-amenable species entering a federally inspected plant must be shown to comply with any applicable requirements of other Federal, state, local, and foreign agencies before they may be used as ingredients in USDA inspected products? Note that 9 CFR 424.21 makes ample reference to FDA requirements for minor and potential additives. Should we do less for major components of the finished product?
- Under 318.1(c) every article……shall bear a label showing the name of the article. What will be considered an appropriate label for non-amenable specie carcasses?
5. How does FSIS plan to ensure that non-amenable species ingredients are “wholesome”? In other words that the animal carcasses or tissue were not from diseased animals, temperature abused, do not include illegal tissue residues, and are not otherwise contaminated? Example: Alligators are usually harvested during a pre-determined “season” and are often loaded into 18-wheeler tractor trailers for extended periods of time with no refrigeration. These animals would not pass inspection in most states. - Follow-up Question: How can anyone be sure that inspected products containing unregulated, non amenable species-derived ingredients are safe?
- What does FSIS mean by “un-inspected”? Are you referring only to the absence of inspection under the FMIA or PPIA (meaning continuous on-site), or are you referring to the absence of any inspection, including that by other regulatory agencies such as FDA, state or local food inspection programs?” As you are aware, the states collectively conduct over 80 percent of the inspections of FDA-regulated products, including over 13,000 contract inspections conducted for the FDA. Further, most states license and inspect all such facilities on a routine basis. Is FSIS considering this fact when using the term “un-inspected?” Should the term be “inspected by another food safety program with appropriate jurisdiction?”
- Even non-amenable species may not have “…..died otherwise than by slaughter…” How will FSIS go about restricting non-amenable ingredients to product meeting this requirement? Examples of concern include alligator and rattlesnake, which are usually shot, speared, or chopped to death by hunters.
- Although one might think that requiring “cat” or “dog” to be listed in the ingredient statement of an FSIS-inspected product would deter anyone from consuming such products, we know that such products, if made legal, would be greatly sought after by certain ethnic communities. Has FSIS given any further thought to this issue? Backlash from animal rights groups? What about rats as an ingredient?
- How does FSIS envision that a HACCP Plan can support the safety of these products if one or more of the ingredients are not from an approved source?
We appreciate USDA’s consideration of these questions and hope that they will help to clarify the agency’s intent concerning the use of non-amenable animal tissues in USDA inspected products. Marion Aller, President Association of Food and Drug Officials |
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