CVM Update
Comments by Stephen F. Sundlof, D.V.M., Ph.D.
Director, Center for Veterinary Medicine
Food and Drug Administration
To the National Research Council Public Workshop
"Emerging Animal Diseases:
Global Markets, Global Safety"
Washington, DC
January 15, 2002

Animal pathogens -- CVM's role in protecting animals and food safety in the U.S.

• Preventing animal pathogens to protect animals, and to protect food safety in the U.S., is a team effort that involves several parts of the Federal Government
• Each part has its own authority, expertise, and jurisdiction
• The differences are difficult to see from the outside looking in
  • Which can sometimes lead to confusion
  • For instance, USDA's -Animal and Plant Health Inspection Service -- has responsibility for monitoring, tracking, and taking steps to control animal disease in the U.S.
  • But FDA's CVM has the responsibility for making sure feed is as safe as possible so that it is not a vehicle for transmission/dissemination of pathogens or toxins
  • That is why CVM has responsibility for taking steps to prevent BSE, while USDA would take charge if Foot and Mouth Disease was discovered in the U.S.
• Also, what some may not realize is that States also play an important role
  • In some case States can take action more quickly than the Federal Government
• What this means is: All parties, Federal and State, share the responsibility to make a broad network to protect animals and the safety of food in the U.S.

• CVM's authority to regulate feed gives the Center the authority to take actions concerning BSE, even though BSE clearly is an animal disease
  • FDA is also interested in control of BSE because scientists suspect the consumption of protein from infected cattle can cause variant CJD in humans
  • The rules we developed for the feed and rendering industries are based on science and on actual risk
  • CVM is not working alone
    • FDA collaborates with other Federal Government Agencies and with States for controlling imports and doing domestic inspections of feed mills and renderers
  
  
• Imports - first line of defense
  • CVM/FDA works with USDA and U.S. Customs Service to prevent imports of live animals or products that could be infected with BSE
    • USDA identifies BSE countries
    • USDA and FDA cooperate in identifying animal, feed, or other imports from BSE countries that may allow BSE to enter the U.S.
  • FDA coordinates with USDA's APHIS on import restrictions
    USDA and FDA work with the U.S. Customs Service to watch for prohibited material coming to the U.S.
  
  
• Second line of defense - feed regulation
  • After imports, the second line of defense is CVM's feed rules
  • No case of BSE has been discovered in the U.S., despite a decade-long program of active and intensive searching for BSE infected cattle
  • But, if animals in the U.S. became infected with BSE, the feed rule will prevent the amplification and spread of the disease in the U.S. cattle herd
  • That BSE epidemic in the UK showed that BSE is spread virtually exclusively through consumption of animal feed containing infectious material from other cattle
  • What that means is: With a single point of disease transmission - feed - we wrote the rule to control the potential for infect at that one point
  
  
• Quick synopsis of the rule
  • It prohibits feeding most mammalian protein to cattle and other ruminants, with some exceptions, such as:
  • Blood and blood products
  • Milk and milk products
  • Pure porcine or equine meat, and pure porcine and equine meat-and-bone meal
  • Gelatin
  • Plate waste
• Inspections and enforcement
  • We are working with ORA and States on inspections and enforcement
• Through an intensive effort over the past four years, we have identified all firms (except individual cattle producers) who handle or could handle prohibited material - renderers, and commercial feed mills
  • Our plan for inspection for 2002, with the steps in order of priority, is -

    1. All firms that have been found to be in violation of the BSE feed rule at their most recent inspection, regardless of whether that was an initial or follow up inspection

    2. For-cause inspection; conducting an inspection when we have information that a firm and/or products may be in violation of the law

    3. All firms that were identified as handling prohibited material at their last inspection

    4. Those firms, livestock producers, or individuals who are feeding animals and/or mixing feed and subject to a follow-up inspection for a tissue residue violation

    5. Renderers, feed mills, salvagers not found to be handling prohibited material during their last inspection

  • What this means is: Our action plan for 2002 is based on going to the sources of highest risk first, and then get all other potential sources of risk
• Risk assessment finds little risk for U.S.
  • The assessment, conducted by the Harvard Center for Risk Analysis, said that the U.S. faces little threat from the disease coming into the U.S.
    • Current system - especially the feed ban - is adequate to keep the disease from becoming established and amplified, even though we have not yet achieved 100% compliance, the report said
  • What this means is: A thorough, yet theoretical, examination of the effects of the safeguards that the U.S. has put in place about BSE show that the risk very small, even with the imperfections with the feed rule

• Antimicrobial resistance survey focusing on feed commodities
  • In FY 2000, CVM undertook a project to determine the role feed ingredients play in disseminating antibiotic resistant bacteria
  • Researchers there cultured 175 samples of feed to determine resistance in Enterococcus
    • They looked at poultry by-product meal, meat and bone meal, blended animal proteins, and whole grains (corn and oats)
  • The intent of the survey is to learn how resistance is created and spread in the animal production environment
    • Various Enterococcus species were isolated and tested for susceptibility to 17 antibiotics
    • Except for corn and poultry meal, all of the samples were positive for enterococci
      • The corn samples were only 41% positive
      • The poultry meal 95% positive
    • Resistance to antibiotics used in human therapy was seen mostly in isolates recovered from meat and bone meal
  • What this means is: The data suggest:
    • That the prevalence of antibiotic resistance found in isolates from the animal production environment is far greater than resistance found in enterococci isolated in feed commodities