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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Veterinarian Newsletter 2002 Volume XVI, No VI

FDA has issued an Advance Notice of Proposed Rulemaking (ANPRM) asking for information and views on some potential changes to its current regulation prohibiting the use of certain proteins in ruminant animal feed. The current regulation is posted on the FDA/CVM Home Page.

FDA put this regulation in place in 1997 to prevent the spread through animal feed of the agent of bovine spongiform encephalopathy (BSE) were it to enter the U.S. FDA is considering revising this regulation and therefore is asking the public for comment on possible modifications to the rule. This information may be used to help draft a proposed rule in the near future.

On October 30, 2001, FDA held a public hearing in Kansas City, MO to hear views from the public on the adequacy of the present BSE feed regulation. Shortly after the public hearing, the U.S. Department of Agriculture (USDA) released a report prepared by the Harvard Center for Risk Analysis on the findings of a major 3-year initiative to develop a risk assessment model that allows evaluation of the impact of various risks and potential pathways for exposure of U.S. cattle and U.S. citizens to the BSE agent. The assessment of the present situation in the U.S. using this model 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. The model also demonstrated that certain new control measures could reduce the small risk even further.

USDA's BSE surveillance program supports the findings of the Harvard study that measures implemented by the U.S. government, such as early import restrictions and the feed ban have been effective in preventing the entrance and establishment of BSE in the U.S. cattle population. The USDA surveillance program, which has been in place since May 1990 and is targeted at the highest risk cattle population, has found no cases of BSE to date. Although BSE has not been detected in the U.S., the U.S. government's response to BSE has always been proactive and preventive. Therefore, USDA and FDA are interested in exploring measures that could further reduce the already small risk that BSE will enter and become established in the U.S. To that end, FDA is once again asking for information from the affected industries and the public on several ways that the animal feed regulation could be strengthened.

In the ANPRM, FDA solicited information and comments from those with interest and expertise in any of these five aspects of the BSE feed regulation:


    FDA is asking for 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?

    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 prior to inclusion in animal feed?
    • What will be the adverse and positive impacts (economic, environmental, health, etc) resulting from banning poultry litter in ruminant feed?

    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, 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?

    The Agency 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?

    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. 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 prior to inclusion in ruminant feed?
    • What would be the adverse and positive impacts (economic, environmental, health, etc.) from excluding plate waste from ruminant feed?

Written or electronic comments in the ANPRM should be submitted by February 6, 2003, to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments may be submitted. All comments should include Docket No. 02N-0273.

Further information about the ANPRM may be found in the November 6, 2002, Federal Register and from Ms. Linda Huntington, Executive Secretariat, Office of the Commissioner (HF-40), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4443.

It is important to note that while FDA is seeking information on these five areas in the ANPRM, these are not the only part of the BSE feed regulation that might be changed. All parts of the current regulation are under review from both the scientific perspective and FDA's ability to enforce the regulation.