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July 9, 2004
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.
The interim final rule also requires that FDA-regulated food and cosmetic manufacturers and processors make available to 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:
Specified risk materials from cattle of any age are the
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:
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.
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.
