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Public Health Service |
| Rockville MD 20857 |
July 9, 2004
Dear Colleague:
On July 9, 2004, the U.S. Food and Drug Administration (FDA), Department of Health and Human Services, issued an interim final regulation, entitled "Use of Material Derived from Cattle in Human Foods and Cosmetics" and a companion proposal entitled Recordkeeping Requirements for Human Food and Cosmetics Manufactured from, Processed with, or Otherwise Containing, Material from Cattle." FDA is issuing the interim final rule and the proposal to put in place measures intended to minimize human exposure to materials, collectively referred to as prohibited cattle materials," that scientific studies have demonstrated are most likely to contain the bovine spongiform encephalopathy (BSE) agent in cattle infected with the disease. It is widely accepted that consumption of products contaminated with the agent that causes BSE can result in the human disease, variant Creutzfeldt-Jakob disease.
FDA is issuing the interim final rule to ban the use of prohibited cattle materials, which may contain the BSE agent, in human food, including dietary supplements, and cosmetics. Prohibited cattle materials include "specified risk materials," small intestine of all cattle, material from non-ambulatory disabled cattle, material from cattle not inspected and passed for human consumption, and mechanically separated (MS) beef. "Specified risk materials" are defined as certain materials from animals 30 months of age or older and include 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 dorsal root ganglia. "Specified risk materials" also are defined as tonsils and distal ileum of the small intestine from cattle of all ages.
Prohibited cattle materials do not include tallow that contains no more than 0.15 percent hexane-insoluble impurities and tallow derivatives.
The scope of the interim final rule includes food (dietary supplements, dietary ingredients, infant formula, and exempt infant formula), food ingredients including generally recognized as safe (GRAS) substances, food additives including food-contact substances, and cosmetics and cosmetic ingredients. The interim final rule also requires manufacturers and processors of FDA-regulated human food and cosmetics to make available to FDA, upon request, any existing records relevant to their compliance with the interim final rule.
FDA is taking this action in response to the finding of an adult cow that tested positive for BSE in the U.S. State of Washington. This action is consistent with the recent interim final rule issued by the U.S. Department of Agriculture (USDA) declaring these materials to be inedible, unfit for human food regulated by USDA, and prohibiting their use as human food regulated by USDA.
As a companion proposal to this interim final rule, FDA is proposing to require that manufacturers and processors of human food that is manufactured from, processed with, or otherwise contains material from cattle establish and maintain records sufficient to demonstrate that the food is in compliance with this IFR. It is proposed that these records be retained for 2 years, and be available to FDA for inspection and copying.
Importers must electronically affirm, at the time of entry into the United States, their compliance with the recordkeeping requirements and, if requested, provide the records within a reasonable time.
FDA is proposing recordkeeping requirements because records documenting the absence of BSE risk materials are needed by manufacturers and processors of human food and cosmetics that contain bovine material to ensure that these products do not contain BSE risk materials. In addition, such records are necessary to help FDA ensure compliance with the requirements of the interim final rule.
In addition, FDA and USDA have published an advance notice of proposed rulemaking (ANPRM) that requests comment and scientific information on additional measures under consideration to help prevent the spread of BSE. FDA is requesting public comment and scientific information on several measures related to animal feed under consideration. Some of these measures include:
In addition, FDA has tentatively concluded that it should propose to remove SRMs from all animal feed and is currently working on a proposal to accomplish this goal.
If you have any questions regarding this matter, please contact Beverly Corey, D.V.M., Director, International Relations, Office of International Programs, FDA. Dr. Corey may be reached at (301) 827-0855. Additional information can also be found at FDAís website www.fda.gov.
Sincerely,
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Department
of Health and Human Services