These high-risk cattle materials prohibited in the new proposed rule include:
• the brains and spinal cords from cattle 30 months of age and older;
• the brains and spinal cords from cattle of any age not inspected and passed for human consumption;
• the entire carcass of cattle not inspected and passed for human consumption if the brains and spinal cords have not been removed;
• tallow that is derived from the materials prohibited by this proposed rule if the tallow contains more than 0.15 percent insoluble impurities;
• mechanically separated beef that is derived from the materials prohibited by this proposed rule.
Dr. Stephen Sundlof, director, FDA’s Center for Veterinary Medicine, estimates the amount of proposed prohibited material to be “relatively small,” about 64.3 million pounds. In an advanced notice of proposed rulemaking (ANPR) released jointly by FDA and the U.S. Department of Agriculture (USDA) in July 2004, the agency proposed banning an estimated 2.1 billion pounds of specified risk materials (SRMs) in all animal feed. SRMs are defined differently by the USDA than the “cattle materials prohibited from animal feeds” addressed in this new proposed regulation.
In the July 2004 ANPR, FDA asked for comments on banning SRMs in all animal feed and also on other feed control measures such as prohibiting the use of all mammalian and poultry protein in ruminant feed. The agency also asked for comments on the set of measures that the agency had announced in January 2004, including the elimination of the exemptions for blood and blood products and “plate waste” from the 1997 ruminant feed rule, a prohibition on the use of poultry litter in ruminant feed, and a requirement for dedicated equipment and facilities to prevent cross-contamination.
After analyzing the comments it received on the 2004 ANPR, FDA concluded that the other feed control measures discussed previously are not needed if the high-risk tissues identified in this proposed rule are excluded from all animal feed. Sundlof said the proposed rule released in October will remove 90 percent of infectivity possible in animal feed and apply mostly to renderers.
The proposed regulation builds on a series of firewalls that include FDA’s 1997 feed regulation that prohibits the use of certain mammalian proteins in ruminant feed, but allows these materials to be used in feed for non-ruminant species. According to FDA, the removal of high-risk materials from all animal feed – including pet food – will protect against the transmission of the BSE agent that could occur either through cross-contamination of ruminant feed with non-ruminant feed or feed ingredients during feed manufacture and transport, or intentional or unintentional misfeeding of non-ruminant feed to ruminants on the farm.
Comments on the proposed rule, which can be found on Render’s Web site at www.rendermagazine.com under “In the News,” are due December 20, 2005.
Industry Responds
While preparing to comment on the FDA proposal to change the 1997 feed rule, the National Renderers Association (NRA) released an early rebuttal, stating that if brains and spinal cords are not removed from dead and downed cattle before rendering, these entire carcasses will also be banned from all animal feed.
Independent renderers now pick up many dead and downer cattle and calves from beef and dairy operations, as well as poultry, swine, and horses. Since the 1997 restrictions on feeding of ruminant proteins, the decrease in value of by-products from dead animals has necessitated pick-up charges to farmers and feedlots.
According to NRA, under the proposed rule, renderers would have to invest in equipment to remove and keep brains and spinal cords separate. In hot or cold weather, or in remote locations, many dead cattle will not be in a condition good enough to achieve the required brain and spinal cord removal.
The NRA believes that FDA has underestimated the effects of the proposed rule – that additional regulatory restrictions will have important negative environmental and economic impacts. New rules will likely:
• cause many renderers to cease pick up of dead cattle;
• cause renderers to increase pick-up charges, causing farmers to seek alternative disposal;
• increase the incidences of inappropriate disposal;
• cause the economics of many pick-up routes to be so poor that other species will also cease to be picked up.
Renderers also collect offal from custom slaughter and locker plants as well as small packing plants. NRA has said that new rules will likely:
• require these operations to separate brains and spinal cord from offal going to rendering;
• cause renderers to increase pick-up charges, causing plant operators to seek alternative disposal;
• increase the incidences of inappropriate disposal.
“The increased inappropriate disposal of dead animals and offal will lead to environmental and animal health problems that are not accounted for in the FDA proposal,” said NRA President Tom Cook. “In trying to rid the United States of an extremely small risk of spreading BSE in cattle, the proposed FDA regulation could increase the real risk of many other animal diseases.”
Using the assistance of Informa Economics, NRA conducted a survey of their members to ensure the most up-to-date and credible statistics on quantity of prohibited material and the economic impact are presented to FDA. The association will be submitting their comments on the proposed rule by the December 20, 2005, deadline and encourages others to also respond.
State Vets Echo Industry’s Concerns
While some industry associations support the FDA proposed feed rule, such as the Pet Food Institute and National Grain and Feed Association, one group is concerned the rule could have unintended consequences.
The U.S. Animal Health Association (USAHA), an organization comprised of state and federal animal health officials, veterinarians, livestock producers, and other organizations concerned with animal health, including the NRA, often has considerable influence with policy at the regulatory agencies, more so with USDA than with FDA. As timing would have it, the USAHA held their 109th annual meeting in early November where the FDA proposed feed rule was discussed in length, resulting in the group adopting several pertinent resolutions.
1. The USAHA urges FDA to more thoroughly evaluate the unintended consequences of changes in the rule so that reducing a very small risk from BSE does not lead to a carcass disposal crisis in many parts of the country.
2. The USAHA urges the Secretary of Agriculture to create a national SRM task group to develop a viable national plan with state and affected industry stakeholders to utilize and/or dispose of SRMs to be prohibited from entering the animal feed supply if the FDA proposed rule of October 4, 2005, is adopted. The plan should:
• minimize the potential economic impact upon cattle producers and the rendering industry;
• maintain economical on-farm dead stock recovery by the rendering industry and enhance animal disease surveillance by USDA and the states;
• develop value added markets for nonambulatory and dead stock that cannot be utilized in the feed supply, and develop safe utilization and disposal options that minimize public health and environmental concerns.
The USAHA’s National Assembly, which consists of all the state veterinarians, adopted a resolution encouraging state veterinarians, state departments of agriculture, and livestock health commissions to work with their livestock and rendering industries to gather accurate carcass disposal data for their state and to provide the information to FDA before the comment period of the proposed feed rule ends December 20, 2005.
They are also encouraged to educate their state environmental agencies on the potential impact of the rule and support policies that encourage other potential uses of meat and bone meal not eligible for animal feed, such as biofuels. The National Assembly also encourages FDA and USDA to thoroughly review all comments and additional data provided during the comment period and assess the probability for a carcass disposal crisis in many states before implementation of the rule.
NRA credited the actions of USAHA and its National Assembly to NRA members, who were encouraged to contact their state veterinarians prior to the meeting and voice their concerns about the FDA proposed feed rule.
December 2005 Render