The rule prohibits the use of cattle-derived materials that can carry the infectious agent for bovine spongiform encephalopathy (BSE) in human foods, dietary supplements, and cosmetics. Based on the scientific information provided during the interim final rule’s comment period, which demonstrated that a part of the cow’s digestive tract called the distal ileum can be consistently and effectively removed from the other sections of the small intestine, it is no longer necessary to designate the entire small intestine as a prohibited cattle material.
As a result, FDA is amending the rule to allow use of the small intestine in human food and cosmetics, provided that the distal ileum has been removed. The U.S. Department of Agriculture (USDA) published a similar amendment to its interim final rule on BSE.
The amendments also clarify that milk and milk products, hides and hide-derived products, and tallow derivatives are not prohibited for use in human food and cosmetics.
Finally, in response to information submitted to the agency, FDA has reconsidered the recommended method for determining insoluble impurities in tallow and will allow the American Oil Chemists’ Society (AOCS) method for measuring insoluble impurities in tallow. The July 2004 interim final rule required that the method described in the fifth edition of the Food Chemicals Codex (FCC) be used to measure hexane-insoluble impurities in tallow.
Comments to FDA from such organizations as the National Renderers Association and Animal Protein Producers Industry stated that the domestic tallow industry primarily uses the AOCS method to measure insoluble impurities in tallow. The AOCS method is also less expensive, requires less solvent, has lower solvent disposal costs, and does not require specialized equipment or supplies compared to the FCC method. The amended interim final rule does not exclude use of the FCC method. Any testing method may be used that is equivalent to the AOCS method and it is not necessary that FDA approve the use of an alternate test.
FDA issued the interim final rule to minimize human exposure to materials that studies have shown are highly likely to contain the BSE agent in cattle with the disease. The amended interim final rule provides the same level of protection against the agent that causes BSE as the original provisions.
The amendments to the interim final rule are effective on October 7, 2005, and comments are being accepted on the amendments through November 7, 2005.
Investigation Shows Firewalls are Working
The USDA’s Animal and Plant Health Inspection Service (APHIS) and the FDA have completed their investigations regarding a cow that tested positive for BSE in June 2005. The agencies conducted these investigations in collaboration with the Texas Animal Health Commission and the Texas Feed and Fertilizer Control Service.
Results indicate that the positive animal, called the index animal, was born and raised on a ranch (termed the “index farm”) in Texas. It was a Brahma cross approximately 12 years old at the time of its death. It was born prior to the implementation of the 1997 feed ban instituted by FDA to help minimize the risk that a cow might consume feed contaminated with the agent thought to cause BSE. The animal was sold through a livestock sale in November 2004 and transported to a packing plant. The animal was dead upon arrival at the packing plant and was then shipped to a pet food plant where it was sampled for BSE. The plant did not use the animal in its product, and the carcass was destroyed in November 2004.
APHIS attempted to trace all adult animals that left the index farm after 1990, as well as all progeny born within two years of the index animal’s death. Together, these animals are called animals of interest.
During the course of the investigation, USDA removed and tested a total of 67 animals of interest from the farm where the index animal’s herd originated. All of these animals tested negative for BSE. Two hundred adult animals of interest were determined to have left the index farm, of which 143 had gone to slaughter, two were found alive (one was determined not to be of interest because of its age and the other tested negative), 34 are presumed dead, one is known dead, and 20 have been classified as untraceable. In addition to the adult animals, APHIS was looking for two calves born to the index animal. Due to record keeping and identification issues, APHIS had to trace 213 calves, of which 208 entered feeding and slaughter channels, four are presumed to have entered feeding and slaughter channels, and one calf was untraceable.
To determine whether contaminated feed could have played a role in the index animal’s infection, FDA and the Texas Feed and Fertilizer Control Service conducted a feed investigation with two main objectives: (1) to identify all protein sources in the animal’s feed history that could potentially have been the source of the BSE agent; and (2) to verify that cattle leaving the herd after 1997 were identified by USDA as animals of interest and were rendered in compliance with the 1997 ruminant feed rule.
The feed history investigation identified 21 feeds or feed supplements that were used on the farm since 1990. These feed ingredients were purchased from three retail feed stores and were manufactured at nine feed mills. This investigation found that no feed or feed supplements used on the farm since 1997 contained prohibited mammalian protein. Due to this finding, FDA has concluded that the animal was most likely infected prior to the 1997 ruminant feed ban.
The investigation into the disposition of herd mates from this farm involved visits to nine slaughter plants and eight rendering plants. The investigation found that all of the rendering plants were operating in compliance with the ruminant feed rule and had no previous violations of the rule.
APHIS and FDA have announced they are very pleased with the results of their investigations, which show the animals of interest did not present a threat to livestock and that the ruminant feed rule is being followed. The United States maintains an interlocking system of safeguards designed to prevent BSE from entering the human and animal food chain. USDA also remains vigilant in its attempt to find BSE in the United States. As of September 1, 2005, there had been more than 450,000 animals tested in the previous 14 months with only two BSE positive animals found in the United States.
For more information on USDA’s epidemiological investigation and a copy of the report, visit the APHIS Web site at www.aphis.usda.gov/lpa/issues/bse/bse.html or www.aphis.usda.gov/lpa/issues/bse/epi-updates/bse_final_epidemiology_report.pdf.
For more information on FDA’s feed investigation, visit the FDA Web site at www.fda.gov/cvm/texasfeedrpt.htm.
Animal Identification to be Joint Venture
USDA Secretary Mike Johanns has acknowledged livestock industry concerns about the National Animal Identification System (NAIS) and said the system will be a public-private partnership.
“We are eager to work closely with industry as they develop and maintain databases that contain animal movement information,” Johanns said. “After hearing the confidentiality concerns of producers, we envision a system that allows these databases to feed a single, privately held animal-tracking repository that we can access.”
The National Cattlemen’s Beef Association (NCBA) applauded USDA’s announcement. This summer, NCBA selected a team led by BearingPoint, Inc., as a lead technology consultant for its voluntary, industry-based animal identification program in an effort to protect producer rights and confidentiality. The association expects to have their program fully operational by January 1, 2006.
USDA’s guiding principles for the NAIS are as follows:
• The system must be able to allow tracking of animals from point of origin to processing within 48 hours without unnecessary burden to producers and other stakeholders.
• The system’s architecture must be developed without unduly increasing the size and role of government.
• The system must be flexible enough to utilize existing technologies and incorporate new identification technologies as they are developed.
• Animal movement data should be maintained in a private system that can be readily accessed when necessary by state and federal animal health authorities.
USDA solicited public input on the NAIS through a variety of means including the formation of a special subcommittee under the Secretary’s Advisory Committee on Foreign Animal and Poultry Diseases, a series of listening sessions across the country in 2004, and a thinking paper published for public comment in May 2005. Public response indicates there is widespread support for a system to rapidly trace potentially exposed animals in the event of an animal disease outbreak. A majority of producers who responded also favored a system that allows the animal movement data to be privately held.
USDA officials will be scheduling a stakeholder meeting this fall to clarify expectations for the private tracking system and discuss user requirements and system specifications. Once fully implemented, NAIS will enhance U.S. efforts to respond to intentionally or unintentionally introduced animal disease outbreaks more quickly and effectively. More information about NAIS is available at www.usda.gov/nais.
Newsline - October 2005 Render