When the US Food and Drug Administration proposed more restrictive rules in 2004 to keep ruminant materials out of animal feed, it seemed like overkill to many in the feed and rendering industries. At the time, the couple of Canadian cases of bovine spongiform encephalopathy and the sole American case all came from cows born before the 1997 ruminant feeding bans in the USA and Canada. Despite the apparent extremely low incidence of BSE and high level of compliance with the 1997 rule, the FDA proposed to prohibit brains and spinal cords from cattle 30 months of age or older from being used in all feed, including for non-food animals. They also proposed to ban all dead and downer animals, "cattle not inspected and passed for human consumption," from any feed unless the brains and spinal cords are removed. They termed these materials "cattle materials prohibited from animal feed" or CMPAF, a subset of "specified risk materials" or SRMs.

The FDA's comment period on the proposed amendments to the feed regulation extended from October into December last year. Now the agency is considering comments received from all affected groups, including the feed and rendering industries.

If finalized, the proposed rule would also require:

  • Tallow derived from CMPAF and used for feed to meet the OIE (World Organization for Animal Health) standard for global trade of 0.15% maximum insoluble impurities;
  • Require separate equipment or containers to handle prohibited material once it has been separated from other cattle materials;
  • Require labeling of CMPAF with the statement "Do not feed to animals";
  • Require marking of CMPAF with dye; and
  • Require renderers to establish and maintain records sufficient to track the prohibited materials.

The FDA still permits plate waste, blood and blood product, gelatin, milk and milk products, and poultry litter in cattle feed. The proposed changes did not address these items, but FDA asked for comments on them also.

All of agriculture united on disposal problem

Feed and rendering industry groups commented in detail on the proposed FDA rule change since 2004. There were various different levels of concern with what was proposed by FDA, but all of agriculture was united in telling FDA that the disposal problem was not adequately addressed.

As for the National Renderers Association (NRA), we found a number of discrepancies in the FDA's estimates of the proportion of US cattle entering the rendering process and the volumes of prohibited materials. The biggest discrepancy was in the amount of CMPAF material that would need to be disposed of under the proposed rule. NRA has maintained that renderers would be able to remove brains and spinal cord from very few dead and downer cattle, so almost all of them would be diverted to alternate disposal methods. NRA disagreed with FDA's statement that the proposed rule will "not trigger wider, rippling effects through the renderers' situation."

NRA commissioned Informa Economics, formerly the Sparks Companies, to provide a comprehensive analysis of the FDA's assumptions and predictions about the impact of the proposed feed rule. In 2002, the Informa analysts had studied the rendering industry in depth, and, in 2004, they conducted an economic analysis of the proposed rule changes. Their 2005 study included a survey of the rendering industry to collect essential data on the volumes of ruminant material now processed, and what impact further restrictions would have on this essential public health service.

New findings from Informa estimated the direct economic impacts faced by the rendering industry and livestock producers because of the loss of existing channels for cattle and calf dead stock processing to be more than $127.7 million per year. In addition, costs for slaughter facilities to handle and dispose of CMPAF and the significant capital investment that must be made by renderers and meat processors to handle, process and dispose of all material identified by this rule would almost certainly exceed $150 million per year.

The Informa analysis revealed that the proportion of dead stock cattle and calves rendered in the USA far exceeds the 17% assumed by FDA. The 45 firms collecting dead cattle in 2005 process more than half of all adult cattle mortalities and nearly 40% of calf mortalities, accounting for about 45% of all dead and downer cattle in the country. Moreover, the independent analysis projected a severe reduction in the number of dead or downer cattle and calves entering the rendering process because renderers would accept fewer and producers would be less willing to pay higher collection fees.

One of the most worrying impacts is the potential environmental impact, which the Informa analysis also addressed. Faced with collection fees that could double or triple overnight, even the best-intentioned livestock producers will likely be tempted to overlook some environmental concerns in order to save thousands or tens of thousands of dollars. Without enforceable regulation of mortality disposal, unapproved and dangerous methods could find widespread use. The Alabama cow recently confirmed to be infected with BSE illustrates the point: the carcass had been buried on-farm and had to be exhumed to determine the animal was at least 10 years old.

Disposal of CMPAF generated by meatpackers and renderers will be costly, too. No universally appropriate methods of handling and disposal have been identified. Because state regulations often prohibit disposal of this type of material in landfills, and since many other landfills would likely refuse to accept it even if regulations allowed, there is a high likelihood that all of this material will ultimately need to be rendered prior to disposal, greatly increasing the overall cost of disposal beyond FDA's estimate.

Complying with the proposed rule would cost renderers significant amounts, around $11.3 million in annual capital expenditures, plus some $15.7 million from lower sales of meat-and-bone meal and tallow with the lost rendering volume. For the complete NRA response to the FDA, see: http://www.renderers.org/economic_impact/index.htm.

No additional regulation needed

The NRA maintains that no additional regulation is needed. Removing cattle brains and spinal cord and rendered dead animals from all animal feed is not warranted. This action aimed at removing a very minute risk of BSE will increase risks from other diseases, cause environmental degradation, and cost much more than can be justified.

NRA continues to emphasize that the 1997 feed rule is working well and compliance with existing regulations is extremely high. The US Department of Agriculture's enhanced surveillance testing program has found only two indigenous cows to have tested positive for BSE, demonstrating that the incidence of BSE in the USA is near zero.

Moreover, because the impact of the rule would be more than $150 million per year, the impact would exceed the current threshold under Unfunded Mandates Reform Act of 1995, thus requiring an assessment of anticipated costs and benefits before the proposed regulation can be finalized. If FDA is forced to comply with this law, it could delay final implementation of the rule, or better yet, the assessment could expose that the benefit of the proposed rule is tiny compared to the cost.

Keeping regulation based on science

As feed manufacturers and livestock producers have known and relied upon for more than a century, when animals and offal are rendered, their basic protein, fat, and mineral components become safe and useful in feed. The rendering process inactivates virtually all harmful bacteria, viruses, and parasites. Compared with landfills and burial, rendering is effective at controlling biological hazards, including food pathogens (such as E coli, listeria, salmonella, and campylobacter bacteria), organisms that cause diseases (such as anthrax, botulism, leptospirosis, bovine tuberculosis, plague, and tetanus) and surface and ground water pathogens (such as cryptosporidium and giardia bacteria).

NRA continues to support scientifically-based animal feeding regulations to restrict the use of certain animal proteins derived from mammalian tissues used in ruminant feeds, and agrees that animal feed regulations need to be reviewed from time to time if new risks are identified or new, relevant science is brought to light. However, to overreact to very few US cases, especially in light of a massive testing program that shows BSE to not be a problem, nvites tremendous expense to the rendering, feed manufacturing, and animal producing sectors. Eventually, it would lead to poorer animal health, higher food prices, and possibly even public health problems.

Animal, feed, and rendering industries must remain strong on the position that any time regulation strays from scientific risk-benefit analysis, it is on shaky ground.