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Press Release: Mad Cow Prevention Rules Violated by 300 U.S. Companies
FDA Asked to Take Action to Protect Public Health and Farmers - Oct. 10, 2003

Assessment of the FDA’s Mad Cow Prevention Inspection Records
(Technically known as the BSE/Ruminant Feed Inspection Database)
prepared by Friends of the Earth
October 10, 2003

About the New Database:

The FDA made its updated Mad Cow prevention inspection database (also referred to as BSE/Ruminant Feed Inspection Database) available to the public on October 7, 2003 at http://www.fda.gov/cvm/index/bse/RuminantFeedInspections.htm. This new database records whether each inspected firm handles or distributes prohibited material, whether each inspected firm handles ruminant feed, and whether the FDA has taken any enforcement action to prevent Mad Cow disease. The database lists these actions as OAI (Official Action Indicated), VAI (Voluntary Action Indicated) and NAI (No Action Indicated), but in many cases, the FDA lists no action whatsoever. Regarding these new categories, the FDA seems to record an OAI for what it considers the most serious infractions and a VAI for more technical infractions, however, both represent a violation of law. See notes below for the FDA definitions.

In contrast to the new database, the previous database, utilized by the FDA until April 15, 2002, included more information about the firms out of compliance. It listed all of the categories of violations. Each of the inspected firms had a Y (designating “Yes”) or an N (designating “N”) for each of the following questions:

Does the firm receive/process prohibited material?
Are products labeled with caution statement? (The labeling provisions require that products containing material prohibited for use in ruminants must be labeled with the caution statement "Do not feed to cattle or other ruminants.")
Are records being kept in compliance? (The record keeping provisions require firms to maintain sufficient records to track the materials throughout receipt, processing, and distribution.)
Are they handling prohibited and non-prohibited material?
Do they have a system to avoid commingling?

About the higher number of violations and other concerns raised by the new database:

Of the 11,172 firms inspected as of September 23, 2003:

300 firms are listed as in violation of FDA regulations at their most recent inspection. This new total is almost triple the number of firms (a total of 113) listed as out of compliance in the April 15, 2002 CVM Update. Of this 300, 173 handle or distribute prohibited materials. And 32 of these handle both prohibited materials and ruminant feed, making them the most likely firms to spread Mad Cow disease.
1779 firms have no listing of any action taken by the FDA after it completed its own inspection. In other words, the public has no way to know if there was a decision of no action or of corrective action that could help influence marketplace choices made by farmers who use the FDA’s database to rate local feed mills.
Of the 1779 firms with no FDA action listed, 4 handle prohibited material and also handle ruminant feed, and 18 have no listing as to whether they handle prohibited material and ruminant feed. Thus, there are no publicly listed findings for these firms that are clearly at risk of mixing cattle parts into cattle feed.
3133 firms have no listing of whether the company handles ruminant feed. Thus, for more than a quarter of facilities inspected, a piece of information critical to enforcing the law has not been obtained or not properly recorded by the FDA.

About the Inadequacy of the Current Feed Regulations in Preventing Mad Cow

Even if 100 percent of firms in the U.S. were in 100 percent compliance with the current feed regulations, consumers and cattle in the U.S. would still not be fully protected from the risks of deadly Mad Cow disease. The FDA must tighten the regulations to be consistent with those in the European Union. This would mean removing exemptions that allow for the following to be fed to cattle:

Cattle blood as a milk substitute
Poultry manure which can contain unconsumed feed made with cattle parts
Plate waste from restaurants
Pet food which is often fed to cattle after its retail expiration date passes.
It would also be prudent to prohibit feeding cattle parts to pigs which some science indicates may be susceptible to Mad Cow disease.

Notes:

FDA actions are defined in its September 30, 2003 CVM Update (http://www.fda.gov/cvm/index/updates/BSEInspec03.htm) as follows:

“An OAI inspection classification occurs when significant objectionable conditions or practices were found and regulatory sanctions are warranted in order to address the establishment’s lack of compliance with the regulation. An example of an OAI inspection classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspections classified with OAI violations will be promptly re-inspected following the regulatory sanctions to determine whether adequate corrective actions have been implemented”

“A VAI inspection classification occurs when objectionable conditions or practices were found that do not meet the threshold of regulatory significance, but do warrant advisory actions to inform the establishment of findings that should be voluntarily corrected. Inspections classified with VAI violations are more technical violations of the Ruminant Feed Ban provisions such as minor recordkeeping lapses and conditions involving non-ruminant feeds”

“A NAI inspection classification occurs when no objectionable conditions or practices were found during the inspection or the significance of the documented objectionable conditions found does not justify further actions”