(Condensed from an article in Render Magazine, Dec. 2008, http://www.rendermagazine.com )

Renderers, meat packers, feed manufacturers, farmers, and other related industries are trying to sort out exactly how the new Food and Drug Administration (FDA) enhanced feed rule will affect them starting April 27, 2009.

The new rule expands safeguards against bovine spongiform encephalopathy (BSE) already put in place by FDA's 1997 feed rule, and used Canada's investigation of that country's thirteenth BSE case discovered in June 2008 as an example of why further safeguards are needed. The Canadian Food Inspection Agency determined cross-contaminated feed was most likely the reason a cow born in 2003 became infected with the disease. The United States has diagnosed only two native animals with the disease in June 2005 and March 2006, both of which were atypical cases. A third case diagnosed in December 2003 was in an imported animal from Canada.

The new rule requires certain cattle material be prohibited in animal feed (CMPAF), and defines the material as:

• brains and spinal cords from cattle over 30 months of age;

• entire carcasses of cattle not inspected (ante mortem) and passed for human consumption - unless shown to be less than 30 months of age, or brain and spinal cord are removed;

• entire carcasses of BSE-positive cattle;

• tallow derived from BSE-positive cattle;

• tallow from CMPAF if containing impurities greater than 0.15 percent; and

• mechanically separated beef made from CMPAF.

Currently, under 21 Code of Federal Regulations (CFR) 589.2000, mammalian material is prohibited in ruminant feed but can be used in other animal feeds and that rule will still apply going forward. The 2008 rule adds a new section to the CFR,589.2001.

Cattle slaughterers already remove the brain and spinal cord in accordance with existing U.S. Department of Agriculture regulations that require removal of specified risk materials (SRMs) in cattle 30 months of age and older processed for human food. Under the new FDA feed rule, slaughter facilities will need to separate the brain and spinal cord from the rest of the SRMs if the animal is 30 months of age or older and the material is going to be rendered. Even though slaughter facilities are not regulated and inspected by FDA, renderers should require their suppliers to have procedures and records in place to meet the new FDA requirements to ensure they are in compliance.

Downer animals are prohibited from entering the food chain but can continue to be rendered under the new rule, provided they are either under 30 months of age or the brain and spinal cord have been removed if 30 months of age and older. The same applies to dead stock received from farms. As for methods to determine the age of cattle, again FDA is not prescribing a particular method, just what industry standards are in place, such as animal identification, dairy herd records, dentition, body weight, or feedlot origin. Hodges said the packing industry primarily uses dentition to determine an animal's age. Again, written procedures will need to be in place so renderers are assured suppliers are in compliance with the FDA rule. If suppliers prefer not to separate CMPAF, renderers must consider all material collected as CMPAF.

Under the new rule, all tallow from non-CMPAF sources may be used in non-ruminant feed, whereas tallow from non­CMPAF sources can only be used in ruminant feed if it contains no more than 0.15 percent insoluble impurities. Tallow from CMPAF can only be used in ruminant and other animal feed if it contains no more than 0.15 percent insoluble impurities. Specific analytical methods to determine those insoluble impurities include the American Oil Chemists' Society Ca 3a­46, or another method equivalent in accuracy, precision, and sensitivity. The rule states that tallow should be sampled at the point where it is ready to go into distribution.

The rule allows foreign countries such as Australia and New Zealand who are declared "negligible" for BSE by international organizations to petition the FDA for exemption from the rule requirements. Otherwise, all countries must comply with FDA's new rule for those rendered products being exported to the United States. All countries must continue to comply with the 1997 feed rule.

FDA expects 28 million pounds of CMPAF from slaughter facilities will initially be disposed of in landfills. The agency is forecasting a 26 to 41 percent decrease in cattle mortalities being sent to rendering, translating to 363 million to 577 million pounds of material being disposed of by means other than rendering. This translates to a tremendous economic impact to the rendering industry, estimated by FDA to be anywhere from $64 million to $80.5 million per year. The agency estimates the cost to cattle producers will be from $28 million to $39 million per year due to lower cattle prices to offset segregation and disposal costs at slaughter, loss for cattle no longer rendered, and increased dead stock collection fees. The new rule also raises a big concern among the livestock industry about improper carcass disposal, which FDA does not regulate.

FDA estimates that less than 150 U.S. rendering facilities in about 30 to 32 states will be subject to the new rule.

So how do renderers comply with the rule, especially since there is no practical way of testing for brain and spinal cord in raw material, rendered products, or finished feed? Documentation, documentation, documentation. Under the new rule, renderers who collect cattle material for animal feed must have documentation from each supplier that CMPAF has been removed and separated. Renderers should request a copy of a supplier's written procedures to determine age of cattle and procedure to remove CMPAF. They should also ask suppliers how CMPAF or SRMs are being disposed of if not being collected for rendering - just for their own records. Suppliers need to be aware that they could be held criminally liable for false information provided to renderers.

How frequently raw material documentation needs to be updated will depend on the supplier's operation and type of supplier, but documents should be updated at least once a year. Renderers who collect dead stock should request documentation on each collection. Documentation will provide renderers a "warranty" that suppliers are complying with the new regulation. The rule allows and even encourages use of a third-party certification, especially for slaughter facilities supplying to renderers.

The new rule also puts in place "marking" procedures intended to make clear to feed manufacturers that material containing CMPAF cannot be fed to any animals. Raw material that contains CMPAF must be marked by an agent visible to the naked eye, unless the material is to be rendered for the tallow. If the material is rendered, tallow exceeding 0.15 percent insoluble impurities and meat and bone meal must be marked. FDA is recommending one of several marking procedures used in Europe and Canada. Product intended for export must be labeled and marked in compliance with the importing country's regulations.

For more information on the new rule, log on to: www.fda.gov/cvm/bsetoc.html