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July 9,  2004

# FACT SHEET: I. FDA'S New Interim Final Rule Prohibiting Use of Certain CattleMaterials that May Carry the Risk of Bovine Spongiform Encephalopathy in HumanFoods and Cosmetics and II. FDA's Proposed Rule on Recordkeeping Requirementsfor Human Food and Cosmetics Manufactured From, Processed With, or Otherwise ContainingMaterial From Cattle 

In response to the finding of an adult cow that tested positive for BSE in  the State of Washington, FDA is taking action to minimize human exposure to  materials that scientific studies have demonstrated to contain the BSE agent  when they come from cattle infected with the disease. This action is consistent  with the interim final rule issued by the U.S. Department of Agriculture (USDA)  prohibiting certain cattle materials from use as human food. It is widely accepted  that consumption of products contaminated with the agent that causes BSE results  in the human illness, variant Creutzfeldt-Jakob disease (vCJD). In conjunction with  the interim final rule (IFR), FDA is issuing a proposed rule to require that  manufacturers and processors of human food and cosmetics that are manufactured  from, processed with, or otherwise contain material from cattle, establish and  maintain records sufficient to demonstrate that the food and cosmetics are in  compliance with the IFR. 

## I. Interim Final Rule

**What action is FDA taking with this interim final rule?**      - specified risk materials small intestine of all cattlematerial from non-ambulatory disabled cattle
- material from cattle not inspected and passed for human consumption mechanically separated (MS) beef
The interim final rule also requires that FDA-regulated food and cosmetic manufacturers and processors make availableto FDA any existing records that may be relevant to their compliance with the prohibitions in the rule.

**What are specified risk materials?** Specified risk materials, from cattle 30 months and older, are the:
- 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) dorsal root ganglia.   Specified risk materials from cattle of any age are the   - tonsils and 
  - distal ileum of the small intestine.  Prohibited cattle materials do *not* include tallow that contains no more than 0.15 percent hexane-insoluble impurities and tallow derivatives.  **What products are covered by the interim final rule?** All FDA-regulated human food and cosmetics, including:   - Dietary supplements and dietary ingredients Infant formulaCanned and frozen foods
- Bakery goods, snack food, and candy (including chewing gum) Food ingredients, including GRAS substancesFood additives, including food-contact substances
- Cosmetics and cosmetic ingredients.  **How can food manufacturers and processors comply?** Manufacturers and processors who currently use prohibited cattle materials will need to switch to alternative ingredients. In addition, the rule requires that manufacturers and processors make existing records related to compliance with the rule available to FDA for inspection and copying.  **When does the rule take effect?** This rule is in effect as of  July 14, 2004, the date of its publication in the *Federal Register*, however, FDA is providing a  90-day comment period on this interim final rule.  The rule applies to human food and cosmetics manufactured from, processed with, or that otherwise contain material, from cattle slaughtered on or after the interim final rule's effective date.  **How to comment on this interim final regulation:**Comments    on this interim final regulation, (Docket Number 2004N-0081), will be accepted    until October 12, 2004. Written comments can be sent to the Dockets Management    Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061,    Rockville, MD 20852. Comments can be sent electronically to www.fda.gov/dockets/ecomments    or as an e-mail to fdadockets@oc.fda.gov. **Please ensure that you include in your submission the docket number that applies    to your comment: Prohibited Cattle Materials--Docket No. 2004N-0081.**  II.Proposed Rule  **What would be required in the companion recordkeeping proposal?** Manufacturers and processors of FDA-regulated human food and cosmetics that use cattle material in their products would be required to keep records demonstrating that these materials do not contain prohibited cattle materials.  The proposal also would require that manufacturers and processors make these records available to FDA for inspection and copying.  **What types of records would be required?** Generally, FDA would expect a manufacturer or processor to have a signed and dated affirmation, including contact information, from the slaughter establishment stating that cattle material supplied by the establishment in a particular shipment does not contain prohibited cattle materials.  For human food and cosmetics containing tallow, a manufacturer or processor would need  to maintain records (signed, and dated, with contact information) either from the slaughter establishment affirming that the tallow was produced from material containing no prohibited cattle materials, or from the tallow supplier affirming that the tallow contains no more than 0.15 percent insoluble impurities. **How long would the records have to be retained?**  FDA is proposing that these records be retained for two years. **Where would the records have to be maintained?**  Records would have to be maintained at the manufacturing or processing establishment or at a reasonably accessible location.  Electronic records would be acceptable and are considered to be reasonably accessible if they are accessible from an onsite location.  **What about imported human food and cosmetic products containing cattle materials?** Importers would be required to electronically affirm their compliance with these recordkeeping requirements at the time the products enter the U.S. and would have to provide the required records to FDA within a reasonable time, if requested.  **How to comment on proposed regulations:** FDA invites comments    on this proposal, e.g., suggestions to make the proposal more effective or    less burdensome, questions regarding the agency's data or assumptions, submission    of information the agency may not have. The agency is especially interested    in comments on other ways in which the proposed recordkeeping requirements    might be satisfied, as well as comments on whether existing recordkeeping    practices include the required information and, if not, what changes the proposal    would necessitate.    Comments on this proposed regulation, Recordkeeping Requirements    for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise    Containing Material from Cattle, Docket Number 2004N-0257, will be accepted    until  August 13, 2004. Written comments on the proposal can be sent to the Dockets    Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane,    Room 1061, Rockville, MD 20852. Comments can be sent electronically to www.fda.gov/dockets/ecomments    or as an e-mail to fdadockets@oc.fda.gov. **Please ensure that you include in    your submission the docket number that applies to your comment: Recordkeeping    - Docket No. 2004N-0257.**            CFSAN Home |CFSAN Search/Subject Index |CFSAN Disclaimers & Privacy Policy |CFSAN Accessibility/HelpFDA Home Page |Search FDA Site |FDA A-Z Index |Contact FDA
FDA/Center for Food Safety & Applied NutritionHypertext updated by ear/dms/cjm July 9, 2004