In the ANPR, the FDA is seeking comments on five aspects of the feed regulation:
• Excluding brain and spinal cord from rendered animal products;
• Using poultry litter in cattle feed;
• Using pet food in ruminant feed;
• Preventing cross-contamination at feed mills; and
• Eliminating the plate waste exemption.
The animal feed regulation was put in place in 1997 as a preventative measure for bovine spongiform encephalopathy (BSE). To date, no cases of BSE have been detected in the United States. In October 2001, the FDA held a public hearing inviting comments to 17 questions about ways the regulation and its enforcement might be improved. Shortly after the public hearing, the U.S. Department of Agriculture released a report by the Harvard Center for Risk Analysis on the findings of a major three-year initiative to develop a risk assessment model, which concluded that, due to control measures already in place, the risk to U.S. cattle and to U.S. consumers from BSE is very low. According to the FDA, the model also demonstrated that certain new control measures could reduce the very small risk even further.
Exclusion of SRMs
The Harvard risk assessment study identified removal of high-risk tissues, such as brain, spinal cord, gut, and eyes, from human food and rendered material for animal feed, as a way to reduce the potential exposure of humans and cattle to the BSE agent. Therefore, the FDA is asking comments on the following questions:
• Should high-risk materials, such as brain and spinal cord from ruminants two years of age and older, be excluded from all rendered products?
• How feasible would it be for the rendering industry to implement such an exclusion?
• What will be the adverse and positive impacts (economic, environmental, health, etc.) resulting from a brain and spinal cord exclusion?
Poultry Litter in Cattle Feed
In some parts of the United States where cattle are raised in proximity to large poultry production areas, poultry litter, composed of excreta, bedding, spilled feed, and feathers, may be used as a feed ingredient for cattle. The Harvard study said that the risk from the use of poultry litter as a feed supplement should be investigated further. For example, if the spilled feed contained ruminant protein, would this practice represent a significant break in the feed regulations? In order to further investigate possible risk, the FDA is seeking information on the following questions:
• How extensive is the use of poultry litter in cattle feed in the United States?
• What is the level of feed spillage in poultry litter?
• What are the methods used to process poultry litter before inclusion in animal feed?
• What will be the adverse and positive impacts (economic, environmental, health, etc.) resulting from banning poultry litter in ruminant feed?
Pet Food In Ruminant Feed
Under the current regulation, pet food for retail sale is exempt from the labeling requirement and need not bear the caution statement “Do not feed to cattle or other ruminants.” However, if the pet food products are sold or are intended for sale as distressed or salvage items, then, under Section 589.2000(d)(4) in the Code of Federal Regulations, such products must state, “Do not feed to cattle or other ruminants.” In order to assure that salvaged pet food is not used in ruminant feed despite the requirement that it be labeled with the caution statement, the FDA is asking for comments on the following questions:
• Should pet food for retail sale be labeled with the statement “Do not feed to cattle or other ruminants?”
• What would be the adverse and positive impacts (economic, environmental, health, etc.) of such a labeling requirement?
Preventing Cross-Contamination
The Harvard study and the FDA public hearing identified cross-contamination of feed and facilities as a possible BSE risk. The current animal feed regulation permits feed and feed ingredients for ruminant animals to be processed in facilities that also process prohibited proteins. The regulation requires that those firms handling both prohibited and non-prohibited material have a system in place and a written plan to prevent cross-contamination. Suggestions were provided in the preamble to the final rule and in small entity compliance guides on ways to prevent carry-over in shared equipment.
While the regulation requires that those firms handling both prohibited and non-prohibited material have a system in place to prevent cross-contamination, the only way to be sure that there is absolutely no potential for carry-over of, or cross-contamination with, prohibited material is to use completely separate facilities. The FDA is interested in information on control measures, other than dedicated facilities, that apply specifically to transmissible spongiform encephalopathy (TSE) agents and in information on whether such measures can prevent carry-over of prohibited material. The FDA is asking for comments on the following questions:
• 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?
• What steps are firms currently taking to prevent cross-contamination of prohibited protein into ruminant feed, and what are the costs of those steps?
Plate Waste Exemption
The current regulation contains an exemption that permits “inspected meat products which have been cooked and offered for human food and further heat processed for feed (such as plate waste and used cellulosic food casings)” to be fed to ruminants. Although the Harvard study concluded that plate waste posed a minimal risk, the FDA wishes to reconsider this exemption and is seeking information on the following questions:
• To what extent is plate waste used in ruminant feed?
• What is the composition of plate waste and what are its sources?
• How is plate waste processed before inclusion in ruminant feed?
• What would be the adverse and positive impacts (economic, environmental, health, etc.) from excluding plate waste from ruminant feed?
Deadline for Comments
Comments on the ANPR are due by February 4, 2003, to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments may be also submitted on-line at www.fda.gov/dockets/ecomments.
Submit two copies of any comments, except that individuals may submit one copy, identifying the comments with Docket No. 02N-0273.
For further information on the ANPR, contact Linda Huntington, Executive Secretariat, Office of the Commissioner (HF-40), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or call (301) 827-4443.
December 2002 Render