2002N-0273 Animal Proteins Prohibited in Ruminant Feed
FDA Comment Number : EC219
Submitter : Dr. Calvin Schoulties Date & Time: 12/22/2005 03:12:19
Organization : Clemson University
Category : Academia
Issue Areas/Comments
From reliable survey data, I infer from data that there are likely no bovine populations currently infected with BSE in the United States. Negative surveillance data for nearly 20,000 BSE high-risk cattle of 2001, 2002 and 2003 and the over 28,000 BSE high-risk cattle since June 2004 are sufficient scientific documentation not to make the drastic changes detailed in the Federal Register, Part III, Department of Health and Human Services, Food and Drug Administration, 21 CFR Part 589, Substances Prohibited From Use in Animal Food or Feed; Proposed Rule. Specifically, the Food and Drug Administration then has no scientific cause to prohibit the use of certain cattle origin materials in the food or feed of all animals when there is no evidence of occurrence of BSE in the United States. The 1997 rule is sufficient.

The prohibition against certain cattle origin materials in the food or feed of all animals presents new issues to every aspect of the food animal and companion animal industries. There would be un-established consequences to the economic, ecological and human / animal health status for numerous industries. The epitome of disregard for human and animal health comes in the form of prohibition of materials from non-ambulatory disabled cattle and deadstock from use in all animal feeds. This, in reality, means that some of these dead animals could be unattended or be partially buried and, thus, could be available for various animals to feed upon. This disregard would threaten animal agriculture and would be a public health menace. Scientific evidence is available to document the effectiveness of current rendering practices upon such pathogenic microorganisms that far exceeds that which is proposed for disabled cattle and deadstock.

The purported possibility of cross contamination or feeding errors cited in the Federal Register is based on inferences from BSE experiences in the United Kingdom. It is my understanding that compliance by the rendering, feed and livestock feeders in this country since the 1997 regulations were implemented has been exemplary. Where is your data on non-compliance to cross contamination or feeding errors in the United States?

The proposed rule in the Federal Register does not present any data or scientific evidence that warrants its adoption. Fear of BSE and the spread of the etiological prion is legitimate. However, we should not abandon science in coming to grips with our fears. Scientists at Clemson University are partnering with the Fats and Protein Research Foundation to find alternative uses of rendered products as well as to make the processes / outcomes of rendering safer. Good science will yield better solutions than will succumbing to fear.


Calvin L. Schoulties, Ph.D.
College of Agriculture, Forestry and Life Sciences,
Clemson University,
Clemson, SC 29634