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U.S. Department of Health and Human Services

Animal & Veterinary

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BSE Rules - FDA Prohibits Some Cattle Material in Foods, Cosmetics

FDA Veterinarian Newsletter July/August 2004 Volume XIX, No IV

The Food and Drug Administration (FDA) announced on July 9 new rules to prevent the establishment and spread of bovine spongiform encephalopathy (BSE) in the United States, including a prohibition on the use of certain material from cattle in food and cosmetics, a proposed recordkeeping requirement to support that rule, and a request for comments about possible changes to the BSE feed rule.

The changes are designed to prevent human and animal exposure to the agent that causes BSE. That agent has been linked to variant Creutzfeldt-Jakob disease in humans.

FDA announced the ban—of cattle material from FDA-regulated human food products, including dietary supplements, and from cosmetics—in the form of an Interim Final Rule that went into effect immediately upon its publication in the July 14 Federal Register. FDA will accept comments about it until October 12.

Under this rule, FDA prohibits the use of high-risk, cattle-derived ­materials that can carry the BSE agent in human food, including certain meat-based products, and cosmetics. These high risk materials include “specified risk material” (SRM), which is defined as brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse proc­esses of the thoracic and lumbar vertebrae, and the wings of the sacrum) and the dorsal root ganglia of cattle more than 30 months of age. SRMs also include the tonsils and the distal ileum of the small intestine of cattle of any age.

The rule also prohibits the use, in human food and cosmetics, of material from non-ambulatory disabled cattle, the small intestine of all cattle, material not inspected and passed for human consumption, and mechanically separated beef. Tallow that contains no prohibited cattle material or that contains no more than 0.15 percent hexane-insoluble impurities and tallow derivatives may be used in cosmetics and other food products. The insoluble impurities standard is the same as that set for protein free tallow by the Office International des Epizooties (OIE), the international animal health standard setting body.

The changes will make FDA’s regulation of food products consistent with the U.S. Department of Agriculture’s (USDA) regulations issued in January.

In a July 9 joint press release, FDA and USDA said their actions “will minimize human exposure to materials that scientific studies have demonstrated are likely to contain the BSE agent when derived from cattle that are infected with the disease.”
To ensure compliance, the rule also requires that companies make existing relevant records available to FDA. The proposed recordkeeping rule would require manufacturers and processors of FDA-regulated human food and cosmetic products containing cattle-derived material to keep records showing that prohibited materials were not used. The companies would be required to keep their records for two years under the proposed rule.

According to Dr. Robert Brackett, Director of FDA’s Center for Food Safety and Applied Nutrition, speaking during a July 9 press teleconference, the Interim Final Rule “mirrors what USDA did with meat products in January; that is, it prohibits the use of high-risk materials…in human foods, dietary supplements and cosmetics.”


Also on July 9, FDA in conjunction with USDA, announced an Advance Notice of Proposed Rulemaking (ANPRM) that requests public comment on several additional actions the Federal government is considering regarding BSE.

FDA is requesting comment, especially scientific information, on four measures related to animal feed:

  • A requirement for the removal of all specified risk materials (SRM) from all animal feed, including pet food. This measure would control the risks of cross-contamination that could occur throughout the feed manufacturing and distribution process or through misfeeding on the farm.
  • A requirement that anyone handling and storing feed and ingredients during manufacture and shipment has separate equipment or facilities for prohibited and non-prohibited material to prevent cross-contamination.
  • A prohibition of the use of all mammalian and poultry protein in ruminant feed to prevent cross-contamination.
  • A prohibition against the use of materials from non-ambulatory disabled cattle and dead stock in all animal feed.

The ANPRM also includes a report on the work of the International Review Team (IRT, convened by Agriculture Secretary Veneman to review the U.S. actions in response to the case of BSE in the United States) along with a summary of the many actions already taken by each agency on BSE.

In the ANPRM, USDA’s Food Safety and Inspection Service is asking for comments on actions it took earlier to protect against BSE in the human food supply. In addition, it is asking whether a country’s BSE status should be taken into account when USDA determines whether a country’s meat inspection system is equivalent to the U.S. regulations.

USDA’s Animal and Plant Health Inspection Service (APHIS) is specifically seeking comments on the implementation of a national animal identification system. In April, USDA announced the availability of $18 million in Commodity Credit Corporation funding to expedite development of a national animal identification system, which is currently underway. APHIS is inviting comments on when and under what circumstances the program should move from voluntary to mandatory, and which species should be covered now and over the long term.


In announcing the ANPRM, FDA said that it “has reached a preliminary conclusion that it should propose to remove SRMs from all animal feed (including pet food) and is currently working on a proposal to accomplish this goal.”

The key benefit to prohibiting all SRMs from all feed would be that it would prevent all possible cross-contamination between ruminant and non-ruminant feed. The IRT cited evidence in the United Kingdom that shows the dangers of cattle infection that can be caused by the cattle consuming feed that was accidentally contaminated when manufactured in premises that legitimately used mammalian meat and bone meal in feed for pigs and poultry. The IRT also cited an ongoing study at the Veterinary Laboratories Agency in the United Kingdom that shows transmission of BSE with a significantly lower dose of infectious brain tissue than previously thought. Further, the Harvard-Tuskegee Study showed that removing SRMs from all animal feed reduces the potential exposure of cattle to the BSE agent by 88 percent, assuming 10 BSE infected cattle were introduced into the United States.
An SRM ban in all feed could eliminate the need for some other actions previously announced by FDA, such as a potential ban on the use of poultry litter in cattle feed.