"BSE Rule" Compliance Inspections:
Educational Approach is MDA's Top Priority

A Federal rule that prohibits feeding protein derived from the tissues of animals to ruminant animals such as cattle, sheep, goats, deer, elk, bison, and buffalo became effective on August 4, 1997. The purpose of the regulation is to prevent the establishment and amplification of bovine spongiform encephalopathy (BSE) in the United States, and thereby minimize any risk to animals and humans. Since failure to comply with certain provisions of 21 CFR 589.2000 (the BSE Rule) can cause a feed to be considered adulterated, it is the responsibility of the Michigan Department of Agriculture to assure that anyone subject to the BSE Rule, is in compliance with the regulation. This includes animal protein renderers, commercial feed manufacturers, distributors and transporters, and those who feed ruminant animals.

At the start of the program, renderers and the manufacturers and distributors of commercial feeds were the primary focus of inspection and compliance efforts. An educational inspection approach was employed whenever possible to encourage voluntary compliance. A stricter approach to enforcement is now used when firms that are aware of the requirements fail to follow them. BSE compliance inspections are integrated into MDA's routine inspections of commercial feed mills.

With a very high level of compliance routinely being demonstrated by renderers and commercial feed manufacturers and distributors, emphasis will begin to shift to those firms that produce higher risk feeds and to those segments of the industry subject to the BSE Rule who present a reduced risk, such as ruminant feeders, whose compliance needs to be demonstrated in order to maintain public confidence.

Before conducting an inspection, MDA inspectors will review the regulation (21 CFR 589.2000) and the appropriate "FDA Guidance for Industry" for the type of firm to be inspected. These documents and a wide array of other BSE information are available on the website of the FDA Center for Veterinary Medicine. Inspection findings will be reported on a special form called the Report of Inspection for Compliance with 21 CFR 589.2000, commonly referred to as the "BSE Checklist". Links to the various guidance documents can also be found below, under FDA Compliance Guides.

Completing the "BSE Checklist":

As a result of these inspections, the FDA or MDA may perform either trace-forward or trace-back inspections. Therefore, it is very important that the inspector fill out the entire form completely and accurately.

When starting the report, the inspector will complete the header at the top of the report. It must include the name and title of the person interviewed. (The title of the person interviewed is required to establish that they are a responsible spokesperson for the firm and have the authority to make commitments on its behalf.) The inspector will proceed with the inspection and complete those parts of the report applicable to the type of firm being inspected. 

Upon completion of the inspection, the inspector will:

• List all items of non-compliance along with any commitments made by the firm's management to correct those items. If firm was in compliance, the report will indicate this.
• Show if any additional attachments are included and indicate any expected follow-up or enforcement actions.

FDA Compliance Guides:

The following guidance documents have been prepared to assist in compliance with the BSE feed regulation:

• Guidance for Industry:  The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine. Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use 9/97 (pdf)
• Guidance For Industry 60: Animal Proteins Prohibited From Animal Feed; Small Entity Compliance Guide (replaced by Guidance documents 67 through 70)
• Guidance for Industry 67:  Small Entities Compliance Guide for Renderers 2/98 (pdf)
• Guidance for Industry 68:  Small Entities Compliance Guide for Protein Blenders, Feed Manufacturers, and Distributors 2/98 (pdf)
• Guía de la FDA para la Industria Número 68:  Para Mezcladores de Proteínas, Fabricantes de Alimentos para Animales y Distribuidores 2/98 (pdf)
• Guidance for Industry 69: Small Entities Compliance Guide for Feeders of Ruminant Animals with On-Farm Feed Mixing Operations 2/98 (pdf)
• Guía de la FDA para la Industria Número 69:  Para Alimentadores de Animales Rumiantes con Operaciones de Mezclado de Alimentos en la Granja 2/98   (pdf)
• Guidance for Industry 70: Small Entities Compliance Guide for Feeders of Ruminant Animals without On-Farm Feed Mixing Operations 2/98 (pdf)
• Guía de la FDA para la Industria Número 70:  Para Alimentadores de Animales Rumiantes sin Operaciones de Mezclado de Alimentos en la Granja 2/98  (pdf)
• Guidance for Industry 76:  Questions and Answers BSE Feed Regulation 7/98 (pdf)

Salvaged and Distressed Pet Foods:

Some pet foods and treats contain or may contain animal protein products that are prohibited for use in ruminant feed. Salvaged and/or distressed pet foods are sometimes used as livestock feeds or feed ingredients. There is a concern that salvaged and/or distressed pet food may be diverted for use as feed for ruminant animals.

Because of this risk, all pet food manufacturers need to be aware of the proper handling, labeling and use of salvaged or distressed pet foods. Likewise, all persons that feed ruminant animals need to be aware of the components in any pet foods they acquire for livestock feeding and avoid any containing protein ingredients that are ruminant-derived. Any pet food that has been handled as distressed or salvage feed must bear the label statement, "Caution. Do not feed to cattle or other ruminants." Anyone purchasing salvage or distressed pet food to feed ruminant animals should look for this statement.

The Pet Food Institute has prepared a useful and informative booklet intended to assist in complying with the provisions of the BSE Rule that pertain to "Salvage and Distressed Pet Food".  The full cooperation of feed manufacturers, renderers, protein blenders, and feed distributors, as well as the feeders of ruminant animals is needed to insure the safety of the nation's feed and food supply. To quote former American Feed Industry Association president David Bossman, "Anything short of full compliance has the potential to breach the consumer's confidence in our nation's beef supply. Total commitment on the part of the feed industry will help maintain that confidence and keep our country free of BSE."  Total commitment on the part of all ruminant feeders is equally vital if the ban is to be successful.

Additional Information

In order to educate all those involved in the production of feeds or the feeding of livestock about the importance of this regulation and their responsibilities under it, the Association of American Feed Control Officials has created a free brochure. Please print, copy and distribute this brochure to anyone with an interest in this issue.

Download AAFCO Brochures: 

AAFCO BSE Brochure:  Reduce the Threat of BSE "Mad Cow Disease"

en Español:  Reduce el Riesgo de BSE "Enfiermedad de la vaca locas"

Establishments that feed ruminant animals are subject to inspections to determine their compliance with the Federal ruminant protein feeding ban. MDA has developed a brochure to assist livestock producers with the basic information they'll need to prepare themselves for BSE compliance inspections. 

Download MDA Brochure:

Bovine Spongiform Encephalopathy (BSE) - Preparing for On-Farm Inspections  (pdf)