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From: TSS ()
Subject: Lester M. Crawford, D.V.M., Ph.D. Speech before 51st International Congress on Meat Science and Technology (BLOOD OK IN CATTLE FEED)
Date: August 15, 2005 at 9:07 am PST

Speech before
51st International Congress on
Meat Science and Technology

Remarks by
Lester M. Crawford, D.V.M., Ph.D.
Commissioner of Food and Drugs

August 8, 2005


I’m going to switch gears a little bit now and talk to you about an issue that I am sure is of keen interest to many of you in this room, and that is FDA’s regulatory activities related to protecting the American public from the risk of transmissible spongiform encephalopathies (TSEs) of animal origin.

Three TSEs have now been confirmed as existing in the United States. Of course, we have known about our scrapie infected sheep for many years, as well as the endemic areas where Chronic Wasting Disease (CWD) was frequently found in wild deer and elk. But CWD has now spread to other areas of the country, particularly the upper Midwest, and into farmed deer and elk herds, and is now an issue that our Center for Veterinary Medicine (CVM) is following closely. We now have a confirmed case of BSE in a cow that was born in Texas and spent its entire life in the United States. As you know, the first BSE-infected cow found in this country was from Canada and had been infected there.

Just last week we thought we might have found a second native cow, but USDA has announced that confirmatory testing of brain tissue from this cow by the lab in Weybridge, England has turned out to be negative. Both FDA and USDA currently have measures in place to protect the U.S. population from consuming or contacting potential infected material, though both agencies will continue to review the precautions and incorporate any new information that becomes available as the Texas case of BSE is investigated.

All the Product Centers within FDA (drugs, biologics, devices, foods, veterinary medicine) currently have rules in effect for BSE or TSEs because many FDA-regulated products contain bovine ingredients. Products ranging from animal feeds to soups, gravies and sausage casings; from cosmetics and dietary supplements to dental products, wound dressings, heart valves, ophthalmic devices, injectable drugs and vaccines.

FDA’s Center for Veterinary Medicine has the responsibility for implementation and enforcement of the BSE feed rule adopted in 1997, which is our first line of defense to prevent the establishment and amplification of BSE should it be found in the U.S.

The rule prohibits the use of proteins derived from mammalian sources in feed for cattle and other ruminants. All mammalian proteins are prohibited unless they are specifically exempted in the rule. Currently, proteins specifically exempted are: blood and blood products; milk products; pure porcine or equine proteins; and “Plate Waste” – inspected meat products that have been cooked and offered for human food and further heat processed for animal feed. Non-mammalian protein such as protein originating from poultry, marine, or vegetable sources are not subject to the feed rule.

Our enforcement program is based on inspection of records about ingredient sources and feed disposition, and inspection of the processes firms use when handling feed and ingredients to prevent cross-contamination. We inspect 100% of known renderers, protein blenders, and feed mills that process products containing prohibited materials.

In June of this year, CVM issued an update on their feed rule enforcement activities. Out of a total of over 15,600 firms inspected, approximately 4,000 handled prohibited materials, and of those 4000 + firms, only 10 firms, or 0.2% were classified as requiring official action due to lack of compliance in record keeping or processing and contamination-prevention procedures.

In July of 2004, FDA announced that it would propose a ban on the use of specified risk materials, or SRM, in all animal feeds. This rule is currently under development and could include for instance, brain and spinal cord of cattle 30 months and older. Earlier last year we had announced other potential changes being considered, including the prohibition of mammalian blood and blood products in ruminant feed, the prohibition of poultry litter, and the prohibition of “plate waste”. But, we are now focusing our efforts on specified risk materials. The SRM ban is designed to address continuing questions about the potential for infectious material getting into cattle feed.

FDA issued a CWD final Guidance in September of 2003. This guidance would prohibit the use of material from CWD-positive deer or elk in ANY animal feed. Feed containing CWD-positive deer or elk would be considered adulterated and would be recalled or otherwise removed from the marketplace. FDA continues to recommend against using animals from areas declared high-risk, which would include animals in an area declared endemic or a CWD eradication zone, or animals that were in a captive herd during the previous five years that contained a CWD-positive animal. Deer and elk from areas not considered high-risk or from herds without positive animals can be used for non-ruminant feeds but are prohibited from ruminant feeds under the BSE Feed Rule.

FDA’s Center for Food Safety and Applied Nutrition (CFSAN) issued an interim final rule in July of 2004 that became effective immediately, prohibiting the use of specified risk materials (SRMs) in human foods, food ingredients, dietary supplements, infant formulas, food-contact substances, and cosmetics and cosmetic ingredients. At the same time, CFSAN proposed a rule requiring food and cosmetic firms covered by the Interim Final Rule to keep records that would demonstrate that the foods and cosmetics were in compliance with the rule.

SRMs for human foods and cosmetics include: (1) Material from non-ambulatory, disabled cattle; (2) Material derived from mechanically separated beef; (3) Material from cattle not inspected and passed for human consumption; (4) Brain, skull, eyes, trigeminal ganglia, spinal chord, vertebral column, and dorsal root ganglia from cattle 30 months of age or older; and, (5) the tonsils and the distal ileum of the small intestine from ALL cattle regardless of age.

These prohibitions are consistent with an interim final rule issued by USDA declaring these materials to be inedible and prohibiting their use as human food. FDA, USDA and other federal agencies apply consistent policies designed to give the consumer several layers of protection against TSEs. These policies have done a good job, but we are always interested in ways to further increase protections.

Development of tools that would permit us to better detect the infectious agents and to clean processing equipment of TSE contamination would provide even better protection. TSE prevention remains a top FDA goal and we welcome further scientific attention to finding even better solutions. ...


par for the course, more broken promises on TSE regulations...TSS

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