It was nearly six months in the making, but the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) have finally released a long anticipated proposed feed rule that could potentially have far-reaching effects on the rendering industry.
The joint USDA/Animal and Plant Health Inspection Service (APHIS), USDA/Food Safety and Inspection Service (FSIS), and FDA advanced notice of proposed rulemaking (ANPR) requests comments and scientific information on several additional measures under consideration related to animal feed to help prevent the spread of bovine spongiform encephalopathy (BSE) in the United States. Some of these measures include:
• Removing specific risk materials (SRMs) from all animal feed, including pet food, in order to control the risks of cross contamination throughout feed manufacture, distribution, and on the farm;
• 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.
Along with the 53-page ANPR, FDA also issued a 75-page interim final rule that prohibits SRMs, the small intestine of all cattle, material from non-ambulatory disabled cattle, material from cattle not inspected and passed for human consumption, and mechanically separated beef from use in FDA-regulated human food, including dietary supplements, and cosmetics. SRMs are defined by USDA as 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), and dorsal root ganglia of cattle 30 months of age and older, and the tonsils and distal ileum of the small intestine of all cattle. Prohibited cattle materials do not include tallow that contains no more than 0.15 percent hexane-insoluble impurities and tallow derivatives.
The agency also released a proposed rule on record keeping requirements for the interim final rule. All these actions follow previous rules published in January after the discovery of BSE in an imported cow in the state of Washington (see “Newsline” in the February 2004 Render) and are based on recommendations by an International Review Team convened by USDA.
The ANPR allows for a comment period, although different by each agency. FDA will consider all comments received on or before 30 days after date of publication in the Federal Register, which was anticipated to be July 14, 2004. APHIS and FSIS request comments be received no later than 60 days after publication. FDA’s interim final rule took effect immediately upon publication; however, the agency is asking for public comment.
Of concern among industry members is the ANPR’s elimination of SRMs in all animal feed – how this will be carried out and how the material will be disposed of if it is excluded from feed. In its ANPR, FDA is asking various questions about this exclusion, including what scientific data is available that sup-ports or refutes the removal of SRMs to effectively reduce the risks of cross contamination, and the economic and environmental impacts of prohibiting SRMs from all animal feed.
In another effort to avoid possible cross contamination, FDA is reexamining in the ANPR the removal of previous exemptions placed in the 1997 ruminant feed rule – blood and blood products, plate waste, and poultry litter – and the prohibition of all meat and bone meal, including avian, in ruminant feed. The ANPR also questions the feasibility of SRM removal from dead stock and non-ambulatory cattle so the remaining material can be utilized, or whether the entire carcass will be prohibited from animal feed.
As for possible disposal methods of these materials prohibited in feed, one option announced in May by USDA’s Rural Business-Cooperative Service, and mentioned in the ANPR, is a pilot program that would provide loan guarantees to rural small businesses for developing renewable energy systems primarily through use of SRMs, non-ambulatory cattle, or other cattle deemed to be at risk of BSE. In a letter to USDA Secretary Ann Veneman after the announcement in May, the National Renderers Association expressed concern that the program “effectively and totally eliminates the rendering industry from participation.” The ANPR is seeking comments on other “innovative solutions” of disposal.
In all, the ANPR poses 30 questions seeking comments. With a quick response deadline to FDA of 30 days, the rendering industry will be busy gathering the necessary data to ensure their future remains viable.
For more on the ANPR and interim final rules, log onto www.fda.gov/bbs/topics/news/2004/NEW01084.html.
August 2004 Render