BSE Prevention Information
Index
Background
Renderers
Feed Manufacturers and Blenders
Distributors
Ruminant Feeders
In August 1997 the Federal Food and Drug Administration (FDA) passed a new rule that prohibits feeding cattle and other ruminants (sheep, elk, deer, etc.) some commonly used protein feed ingredients made from certain mammalian tissues. These rules were intended to prevent the establishment and spread in the U.S. of bovine spongiform encephalopathy (BSE), commonly referred to as "mad cow disease." This disease caused tremendous losses in the European cattle herds but has not been diagnosed in the U.S. In March 1996 the British government announced a possible link between BSE and a variant form of Creutzfeldt-Jakob disease (CJD), a disease that affects humans. BSE and CJD are progressive degenerative neurological diseases. The causative agent for these diseases is not known. It is not a bacteria or a virus. These diseases have a long incubation period, 2-8 years for BSE in cattle and approximately 13 years for CJD in humans.
Cattle with BSE display behavioral, gait and postural abnormalities. Early in the disease affected animals may display increased apprehension, be sensitive to sound and touch and have a swaying gait. As the disease progresses the affected animals stumble, fall and eventually cannot stand up. It ends with coma, seizure and death. There is no cure or treatment for this disease and it kills 100% of its victims. Examination of the brains from cattle that died from BSE showed a "sponge-like" pattern in the brain tissue. This is the only way that BSE can be diagnosed. There is no blood or tissue test that can detect it.
BSE was first recognized in the United Kingdom in November 1986. It was not long before it was discovered that the agent was transmitted through feed, and specifically, meat and bone meal. In June 1988 the U.K. banned the feeding of ruminant-derived protein supplements back to other ruminants. Through November 1996, 165,000 head of cattle were diagnosed with BSE in the U.K. The disease has also been confirmed in domestic cattle in Ireland, France, Portugal and Switzerland. This epidemic peaked in January 1993 with nearly 1,000 new cases per week. Currently fewer than 200 cases are diagnosed every week.
In 1989 the USDA restricted the import of cattle. The intent was to prevent the possible entry of BSE into U.S. livestock herds. The USDA has also instituted a BSE monitoring program and has examined over 5,100 brains of U.S. cattle that exhibited abnormal behavior, including neurological symptoms. No evidence of BSE has been found in these specimens.
In research and testing done in the U.K. it was found that a normal animal fed one gram of BSE-infected tissue, one time developed BSE.
In an effort to prevent a BSE outbreak in the U.S., and to better respond to such an outbreak should it occur, the FDA passed the BSE Rule and began inspecting for compliance with the rule shortly thereafter. The USDA has also responded with BSE prevention and monitoring programs. Most states reference the FDA's Federal Food, Drug and Cosmetic Act in their feed laws for determining if a feed is adulterated. Therefore, if a ruminant feed contains a prohibited protein source (by FDA rule), it is adulterated under state law as well.
In Colorado, staff from the FDA Denver District office and the Colorado Dept. of Agriculture, Division of Inspection and Consumer Services (Feed Program), are currently conducting the inspections for compliance with the BSE rule.
The FDA BSE rule went into effect August 4, 1997. What does this mean to the average person making, selling or purchasing animal feed? What requirements are they subject to under this rule?
To review, the BSE rule prohibits feeding protein derived from mammalian body parts, such as muscle, organs, and bones to ruminants. These proteins are commonly referred to as "prohibited materials." Some mammalian proteins are exempted and are referred to as "nonprohibited materials." These "nonprohibited materials," that may be fed to ruminants are, blood and blood products, milk and milk proteins, protein derived from PURE pork or PURE horse sources, human plate waste, poultry, fish and vegetable proteins, grease, tallow, fats and oils, amino acids and dicalcium phosphate. Ruminants are defined as mammals whose stomachs have four chambers, such as cattle, buffalo, sheep, goats, deer, elk and antelopes.
Examples of prohibited materials are meat and bone meal, meat meal, bone meal, animal by-product meal, hydrolyzed hair, and hydrolyzed leather meal that come from ruminant animals (cattle, sheep, goat, deer, elk, etc.) A problem may occur when a labeler uses the collective term "animal protein products" on their feed tags. Both prohibited and non-prohibited proteins are included in this group of animal protein product ingredients. A feed manufacturer must be capable of substantiating the ACTUAL protein source used if the collective term is listed as an ingredient in a particular feed.
The BSE rule applies to renderers, blenders, feed manufacturers, feeders, mixers, distributors and haulers.
Renderers
- Renders who do not separate prohibited and nonprohibited materials must label all products "Do not feed to cattle or other ruminants."
- They must maintain receipt and distribution records for one year and, upon request, provide them to FDA or state regulatory personnel.
- If a renderer does separate prohibited and nonprohibited materials they must, in addition to the requirements listed above, obtain their nonprohibited material from single species slaughter houses, prevent commingling of materials and document their procedures to prevent commingling. To prevent commingling or cross-contamination, the renderer must use separate processing equipment and storage facilities and use clean-out procedures such as sweeping, flushing, or sequencing. Written procedures used by the firm must be maintained on site. Any imported products processed by the renderer must meet the same requirements as domestic products. Export products must be clearly marked "FOR EXPORT ONLY."
Feed Manufacturers and Blenders
The same requirements as listed for renders also apply to feed manufacturers and blenders.
A feed manufacturer or blender that produces feed or feed products that contain prohibited materials must label the end products with the caution statement "Do not feed to cattle or other ruminants." In addition they must have procedures in place to prevent any cross-contamination of a ruminant feed with a prohibited material. These procedures must be in writing and available for review by the FDA or state regulatory inspectors.
Ruminant feeds must not contain any prohibited materials, either in the feed formula or from cross-contamination!
In summary, feed manufacturers and blenders must do the following if they manufacture ruminant feeds and/or handle prohibited materials:
All non-ruminant feeds that contain prohibited materials must contain the label caution statement "Do not feed to cattle or other ruminants." In the case of bulk shipments, the statement should be prominently imprinted on the invoice, bill of lading, or the paperwork that accompanies the shipment.
- When switching from making a non-ruminant feed that contains a prohibited material to a ruminant feed a system clean out or adequate sequencing plan, or a combination of separation and clean out must be followed.
This plan must be documented and maintained on site.
- In the feed mill, any prohibited materials should be kept separate from the mixing/processing area where they may contaminate another feed. If a dog or cat is kept on the premises, their food that may contain prohibited materials should also be kept in an area separate from the mixing/processing area.
- All transport vehicles used to deliver both ruminant and non-ruminant feeds must have a written clean out procedure that is followed. Attention should also be paid to vehicles that deliver feed ingredients to the manufacturer/blender. Have these vehicles hauled any prohibited materials in the past? If so, did the hauler clean out the vehicle before carrying any ingredients intended for use in ruminant feeds?
- Receiving records and/or records for incoming feed materials, and distribution records for products that contain prohibited materials must be maintained for one year. These records must be sufficient to track the materials throughout their receipt, processing and distribution. These records must be made available for inspection and copying and maintained for one year from the shipment date. These records should contain the following information:
- Date of receipt or purchase and sale or delivery
- Name and address of the seller
- Name and address of the consignee (purchaser)
- Identification of the product
- Quantity
*Please note that pet food and food that is clearly labeled as intended for laboratory animals is exempt from the BSE rule requirements for listing a caution statement and record keeping unless it is sold as "damaged" or "distressed" and diverted to another use other than feeding pets or laboratory animals. In this case, it must follow all of the requirements listed above.
- If a non-ruminant feed that contains prohibited material is sold to a livestock feeder that also feeds ruminants, the seller of the product should inform the purchaser that the product must not be fed to ruminants.
Distributors
A distributor is "any person who sells, offers to sell, exchange, or barter commercial feed or to supply, furnish, or otherwise sell commercial feed to a contract feeder." Distributors include transporters of feed and feed ingredients, retail feed stores, feed warehouses, renderers, blenders, feed manufacturers.
Distributors must do the following if they handle prohibited materials or feed that contains a prohibited material:
- All products that contain or may contain a prohibited material must bear the caution statement "Do not feed to cattle or other ruminants."
- Records must be kept to track any prohibited materials or feed containing prohibited material throughout their receipt, processing and distribution. The records should contain:
- Date of receipt or purchase and sale or delivery
- Name and address of the seller
- Name and address of the consignee (purchaser)
- Identification of the product
- Quantity
- These records must be maintained for one year and made available for copying by FDA or state feed control personnel.
A retail feed store should make sure that they know which of the products they sell contain prohibited materials/bear the caution statement. Records regarding the sale of these products must be kept for a period of one year. Customers purchasing a product bearing the caution statement should be reminded that the product must not be fed to ruminants. Feeds containing prohibited material should be stored in area where the chance of cross contamination (broken bags) is minimal. Prohibited materials are most commonly found in poultry, swine and pet foods. Pet food labels are not required to bear the caution statement; so as a rule of thumb, try not to store ruminant feeds next to pet food. Check the poultry and swine feed labels for the caution statement. If they contain prohibited materials, store them in an area that is separate from the ruminant feeds.
It may be helpful if the store makes a list of the products containing prohibited materials and keeps this list by the register so that it can be referred to easily. If a computer sales system is used, products containing prohibited material can be "flagged" in the system for easy identification.
Ruminant Feeders
Establishments and individuals that are responsible for feeding ruminant animals must do the following to be in compliance with the FDA BSE rule:
- Maintain copies of all purchase invoices for all feeds received that contain animal protein.
- Maintain copies of labeling for all feeds containing animal protein products. If the labeling is part of an invoice, as with bulk deliveries, the invoice is the labeling.
- Make copies of invoices and labeling available for inspection and copying by the FDA or state feed control personnel.
- Maintain the records for a minimum of one year from the date of receipt of the products.
Please contact us should you have any questions about the FDA BSE rule or how to comply with it.