Docket Management
Docket: 02N-0273 - Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
Comment Number: EC -31

Accepted - Volume 2

Comment Record
Commentor Mr. Dale Dubberly Date/Time 2003-02-04 17:01:36
Organization Florida Dept. of Agriculture and Consumer Services
Category Other

Comments for FDA General
Questions
1. General Comments RE: [Docket No. 02N-0273] Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed Dear Sir or Madam: The Florida Department of Agriculture and Consumer Services, the Florida Feed Technical Council, and the Florida Feed Association, hereafter referred to as we, would like to submit the following comments on the Food and Drug Administration’s Advance Notice of Proposed Rulemaking: Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed, [Docket No. 02N-0273]. 1. Excluding Brain and Spinal Cord From Rendered Animal Products. • Should high risk materials, such as brain and spinal cord from ruminants 2 years of age and older, be excluded from all rendered products? Yes. We believe that the FDA should prohibit the use of specified risk materials (SRM), including brain and spinal cord of ruminants 2 years of age and older, from all rendered products unless definitive scientific studies demonstrate the risks are negligible. • How feasible would it be for the rendering industry to implement such an exclusion? We believe that this question requires a response from industry. • What will be the adverse and positive impacts (economic, environmental, health, etc.) resulting from a brain and spinal cord exclusion? Adverse economic and environmental impacts of an exclusion would most likely include increased operating costs for affected industries as well as possible environmental disposal problems. The positive impact of an SRM ban is the dramatic reduction in potential exposure to BSE as indicated in the Harvard Risk Assessment. 2. Use of Poultry Litter In Cattle Feed. • How extensive is the use of poultry litter in cattle feed in the United States? We cannot comment on the extent to which poultry litter is utilized in cattle feed nationally. However, recent estimates indicate that approximately one million tons of poultry litter are produced in Florida each year. If it is assumed that only 35% of this material is suitable for use in animal feed, then 350,000 tons of poultry litter would be available annually. Considering that the most cost effective method of disposal for this industry by-product is through its sale for use as an alternative animal feed protein source, and that it’s relatively low value generally discourages long range transportation, it is reasonable to assume a significant amount of poultry litter is being incorporated in ruminant feed in Florida. • What is the level of feed spillage in poultry litter? We are not aware of any research conducted in this area, but believe the amount varies substantially with the type of feeding system utilized. We are of the opinion that any spillage of poultry feed containing non-exempt mammalian protein would cause the litter to contain prohibited material, and as such, would be unfit for use in ruminant animal feed. • What are the methods used to process poultry litter before inclusion in animal feed? Methods used to process poultry litter vary considerably, but the most common method is deep stacking. In this ensiling/composting process, associated bacterial action will, under proper conditions, raise the stacked material to a temperature of between 140 and 160 degrees Fahrenheit. This is generally considered sufficient heat to kill pathogens such as E. coli and Salmonella that may be present in raw litter. We believe however, that this process is inadequate as a method for eliminating the infectivity of prions that have been reported to be highly resistant to heat, ultraviolet light, ionizing radiation, and common disinfectants that normally inactivate viruses or bacteria. • What will be the adverse and positive impacts (economic, environmental, health, etc.) resulting from banning poultry litter in ruminant feed? Adverse economic and environmental impacts of banning poultry litter in ruminant feed would most likely include decreased marketing opportunities and/or potential increases in operating costs for affected industries as well as possible environmental disposal problems. The positive effects of eliminating this exemption would include further reduction in the potential for exposure of ruminants to BSE as well as the facilitation of enforcement action based on analytical detection of prohibited mammalian protein in ruminant feed or mislabeled non-ruminant feeds. 3. Use of Pet Food In Ruminant Feed • Should pet food for retail sale be labeled with the statement ‘‘Do not feed to cattle or other ruminants.’’? Yes. We believe that pet food containing prohibited material should be labeled with the referenced caution statement. The present situation wherein pet food must be labeled with the cautionary statement only if diverted from retail sale and sold as salvaged or distressed, presents a significant risk. The responsibility for appropriate labeling of the salvage or distressed products currently rests with the owner of the goods. The appropriate disposition of these products therefore, depends heavily upon the owner’s level of familiarity with the rule and it’s requirements. Addressing this issue at the manufacturing level greatly reduces the opportunity for unintentional distribution to ruminants regardless of where, or under what conditions, the product is sold or consumed. • What would be the adverse and positive impacts (economic, environmental, health, etc.) of such a labeling requirement? Adverse economic and environmental impacts of such a labeling requirement would most likely include decreased utilization of prohibited protein material as an ingredient in pet food and increased formulation costs for affected pet food manufacturers, as well as decreased marketing opportunities and possible environmental disposal problems for producers and/or distributors of prohibited materials. Labeling pet food that may contain prohibited mammalian protein to indicate that the product is not intended for ruminants will help assure they are handled and used appropriately wherever they are encountered. 4. Preventing Cross-Contamination • Are there practical ways, other than dedicated facilities, for firms to demonstrate that the level of carry-over could not transmit BSE to cattle or other ruminants? If so, what is the safe level of carry-over in a feed mill; and • What is the scientific rationale used to establish this safe level? We believe that firms handling both prohibited and non-prohibited materials using common facilities should be required to demonstrate the adequacy of their cross contamination prevention and/or cleanout procedures through analytical verification of product integrity using validated laboratory methodology as it becomes available. We are not aware of any scientifically justified, safe level of carry-over and would presently consider any detectable amount as a violation of the current rule. • What steps are firms currently taking to prevent cross-contamination of prohibited protein into ruminant feed, and what are the costs of those steps? We believe that this question requires a response from industry. 5. Elimination of the Plate Waste Exemption • To what extent is plate waste used in ruminant feed? We do not have data quantifying the extent to which plate waste is utilized in ruminant feed. However, it is known that plate waste derived from various sources, including correctional facilities in Florida, has been distributed for consumption as ruminant feed. • What is the composition of plate waste, and what are its sources? Based on our experience, the composition of plate waste is variable as are the sources. We believe there is significant potential for the inclusion of ruminant products that have not been subjected to additional processing in certain plate wastes. • How is plate waste processed before inclusion in ruminant feed? This again is variable depending upon the source and the user. We recommend re-examination of the current exemption due to the lack of documentation regarding plate waste animal feeding practices and the inadequate controls governing plate waste treatment in the current rule. • What would be the adverse and positive impacts (economic, environmental, health, etc.) from excluding plate waste from ruminant feed? Adverse economic impacts of removing the present exemption would most likely include decreased marketing opportunities for plate waste distributors. The positive effects of eliminating this exemption would include further reduction in the potential for exposure of ruminants to BSE as well as the facilitation of enforcement action based on analytical detection of prohibited mammalian protein in ruminant feed or mislabeled non-ruminant feeds.




EC -31