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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM Releases Draft Guidance on New BSE Rule

by Jon Scheid, Editor
FDA Veterinarian Newsletter 2008 Volume XXIII, No IV

The Food and Drug Administration has developed a draft compliance guide for renderers to answer questions raised by the rendering industry about a rule written to enhance protections against bovine spongiform encephalopathy (BSE).

The draft compliance guide includes topics such as the requirement for removing certain materials from cattle that can no longer be rendered for feed use, methods for determining the age of cattle, liability issues, and requirements for recordkeeping.

The final rule was announced in April 2008. The rule defines “cattle material prohibited in animal feed,” or CMPAF, and prohibits it from any animal feed or pet food. (Text of the rule can be accessed at www.fda.gov/cvm/bsetoc.html.)

Cattle material prohibited from all animal feed as defined by this rule includes brains and spinal cords from cattle 30 months of age or older. Therefore, properly removing the brain and spinal cord and carefully determining the age of cattle are key steps for complying with the rule.

Also included in the definition of cattle material prohibited from all feeds are the carcasses of any BSE-positive cattle, and carcasses of cattle defined as “not inspected and passed for human consumption” (commonly referred to as “deads”) that do not have the brain and spinal cord removed or are not demonstrated to be less than 30 months of age.

The rule also prohibits tallow (defined as fat from cattle) for use in ruminant feed that contains more than 0.15 percent insoluble impurities. And it prohibits the use of mechanically separated beef derived from material that falls under the definition of CMPAF.

The rule places significant responsibility on renderers, who in most cases are the first handlers of animal protein used in feed. Since the rule was published, rendering companies have asked for guidance to make sure they know how to be in compliance, especially with the provisions about adequate removal of the brain and spinal cord. Renderers are also concerned with liability issues, because they receive material, including dead cattle, from many sources over which they have no direct control.

Representatives of the rendering industry have met with Center for Veterinary Medicine officials to discuss the requirements of the rule, according to Shannon Jordre with CVM’s Division of Compliance. In those meetings, and through an ongoing series of email messages and phone calls, the rendering industry has presented its questions and concerns.

CVM initially addressed the industry’s concerns in July 2008 when it issued a document presenting a series of questions and answers about implementing the rule. (www.fda.gov/cvm/bse_QA.htm)

The new draft guidance (#195, “Small Entities Compliance Guide for Renderers – Substances Prohibited From Use in Animal Food or Feed), issued on November 25, 2008 offers more information.

The guidance was published as draft and represents FDA’s current thinking on the topic. Interested parties may comment on the guidance document before it is finalized.

The draft guidance defines CMPAF and states that if “you (i.e., renders) receive, manufacture, blend, process, or distribute any of these materials, you must comply with the provisions of this regulation.”

Removing brain, spinal cord

The draft guidance says that no single method is best for removing the brain and spinal cord, saying instead that companies can select the method that would work the best based on the layout of their plant, the cost of equipment, the skill level of employees, and the availability of alternative means of disposing of tissue surrounding the brain and spinal cord.

Some options for brain removal include using suction equipment to remove the brain through the foramen magnum, which is a large hole at the base of the skull through which the spinal cord passes; opening the skull and removing the brain; or leaving the brain in the skull and treating the entire head as CMPAF.

Options for removing the spinal cord include removing the hide, eviscerating the carcass, and using a saw to split the carcass down the midline to expose the spinal canal; cutting out the spinal cord with surrounding vertebral column; or removing the skeletal muscle or other parts and leaving the remaining carcass - which would contain the spinal cord in place - and treat it as CMPAF.

The approaches presented in the draft guidance are only suggestions. FDA encourages the industry to be innovative in developing better alternatives, according to Dr. Burt Pritchett, a member of CVM’s animal feed safety team and a specialist in BSE.

Cattle aging

Because material taken from cattle under 30 months of age will not be considered CMPAF, the draft guidance explains what methods are acceptable for determining the age of (or “aging”) cattle. The best evidence of age, according to the guidance, is documentation from the current owner, which should include the owner’s name and address and the date and location of the animal’s birth. This documentation should be linked to a marking on the animal, such as an ear tag, implant, or tattoo.

Renderers can also rely on an examination of the animal’s teeth (dentition) to determine age. In cattle, the third and fourth permanent incisors come through the gum line between ages of 24 and 30 months. “Therefore,” the draft guidance says, “cattle would be considered to be less than 30 months of age if the third permanent incisor has not yet come through and grown above the gum line.” The draft guidance includes diagrams of teeth in the mouth of an animal to show what to look for.

Recordkeeping, liability

The draft guidance says renderers can rely on certification from the livestock producer about the age of the animals, or about the fact that CMPAF was separated from other material at a slaughter facility, for example. It further states that the government considers the “knowing and willful making of any false, fictitious or fraudulent statements or representations” about such matters covered by the regulation potentially a criminal offense.

Under the rule, recordkeeping requirements apply to any company that renderers cattle material. In general, the re-cords must indicate that CMPAF was not used to produce animal feed. Often, normal business records are sufficient, the draft guidance said.

Renderers can use third-party certification to verify that a supplier effectively kept CMPAF out of material shipped to the renderer.

Records must be kept for 1 year after they were created. The draft guidance urges renderers to tell their suppliers about the recordkeeping requirement and the requirement to keep the records for 1 year.

Compliance, implementation

The requirement for compliance with the rule begins when the rule goes into effect.

CVM has been taking other steps besides developing the draft guidance to help industry get ready. For example, CVM had participated in two “Webinars” (a seminar held using the Internet and a conference call) with industry to explain the requirements for compliance by the end of 2008. One of the Webinars was for members of the National Renderers Association (NRA) and the American Meat Institute, the National Meat Association, and the American Association of Meat Processors. It was sponsored by the NRA. Another Webinar was with and for members of the NRA, the National Cattle-men’s Beef Association, and the National Milk Producers Federation. This Webinar was also sponsored by the NRA.

The draft guidance is not “prescriptive” in its requirements for compliance, Mr. Jordre said. Instead, it gives companies the flexibility to comply with the intent of the rule.

An important aspect of being in compliance is the documentation of procedures a company uses to keep CMPAF out of animal feed, Mr. Jordre said. Companies should have written procedures they use to determine the age of cattle, remove the brain and spinal cord, and sample tallow for the level of impurities. Companies will also be expected to show that they are following their own written procedures.

State and Federal inspectors have received some preliminary information about the requirements of the rule, Mr. Jordre said. CVM will conduct additional training for inspectors before the rule goes into effect, explaining in detail what to look for during an inspection. Although inspections under the new rule will not begin until after the rule goes into effect, State and Federal inspectors doing inspections at rendering facilities this winter will likely be asking those firms if they are aware of the rule and if they have begun to plan how it will affect their operations.