Long awaited measures to enhance bovine spongiform encephalopathy (BSE) safeguards were announced on Friday. The USDA, FDA and HHS have released a notice the requests public comment on several preventative actions including banning specified risk materials (SRM) from all feeds, including pet food.
An interim rule, a proposed rule and an advance notice for proposed rulemaking (ADPRM) were all announced on Friday. One is a joint USDA Food Safety & Inspection Service (FSIS), USDA Animal and Plant Health Inspection Service (APHIS) and Food and Drug Administration (FDA) notice that asks for public comment on additional preventive actions that are being considered concerning BSE. An interim final FDA rule prohibits the use of certain cattle-derived materials in human food (including dietary supplements) and cosmetics. And a proposed FDA rule on recordkeeping requirements for the interim final rule relating to this ban.
The ANPRM requests comment on the following measures related to animal feed, which is regulated by FDA:
- removing specified risk materials (SRM's) from all animal feed, including pet food, to control the risks of cross contamination throughout feed manufacture and distribution and on the farm due to misfeeding;
- requiring dedicated equipment or facilities for handling and storing feed and ingredients during manufacturing and transportation, to prevent cross contamination;
- prohibiting the use of all mammalian and poultry protein in ruminant feed, to prevent cross contamination; and prohibiting materials from non-ambulatory disabled cattle and dead stock from use in all animal feed.
FDA Director Steve Sundlof explains that one key question the advanced notice asks is whether the proposed measures made by the international review team and comments received over the past few months have scientific information to support changing the firewalls. Sundlof says that in considering some of the other measures, if SRM is removed, is it still necessary to remove poultry litter from ruminant feed to prevent cross contamination?
Individuals will have 30 days to comment on the FDA related rules. Sundlof explains that those comments will then be used to provide a proposed rule which will likely be released before the end of the year.
Canada announced that it intends to require the removal of bovine SRM from the animal feed chain. Sundlof says that the United States has been in close contact with Canada in deciding how the North American approach can be harmonized.
Other rules announced
USDA's Food Safety Inspection Service (FSIS) continues to seek and address comments on actions taken in relation to the BSE mitigation measures and put in place in January 2004. FSIS is also specifically seeking comments on whether a country's BSE status should be taken into account when determining whether a country's meat inspection system is equivalent to the U.S. regulations including the provisions in the FSIS interim final rules.
USDA's 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.
FDA today also issued an interim final rule that prohibits the use of cattle-derived materials that can carry the BSE-infectious agent in human foods, including certain meat-based products and dietary supplements, and in cosmetics. These high-risk cattle-derived materials include SRM's that are known to harbor concentrations of the infectious agent for BSE, such as the brain, skull, eyes, and spinal cord of cattle 30 months of age or older, and a portion of the small intestine and tonsils from all cattle, regardless of their age. Prohibited high-risk bovine materials also include material from non-ambulatory disabled cattle, the small intestine of all cattle, material from cattle not inspected and passed for human consumption, and mechanically separated beef.
This action is consistent with the recent interim final rule issued by USDA declaring these materials to be inedible (unfit for human food) and prohibiting their use as human food.
FDA's interim final rule, in conjunction with interim final rules issued by FSIS in January 2004, 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. Consumption of products contaminated with the agent that causes BSE is the likely cause of a similar disease in people called variant Creutzfeldt-Jakob disease.
Although FDA's interim final rule has the full force and effect of law and takes effect immediately upon publication in the Federal Register, FDA is also asking for public comment on it. In conjunction with the publication of the interim final rule, FDA is also proposing to require that manufacturers and processors of FDA-regulated human food and cosmetics containing cattle-derived material maintain records showing that prohibited materials are not used in their products. FDA is taking this action because records documenting the absence of such materials are important to ensure compliance with requirements of the interim final rule.
Publication of this USDA-FDA notice, as well as the two FDA documents, is scheduled for July 14th in the Federal Register.
Comments should be submitted as directed in the addresses section of each document. Each document also provides information about how and where comments received may be viewed.