April 22, 1997

Dockets Management Branch (HFA-305)
Food and Drug Administration
12420 Parklawn Dr.
Rm. 1-23
Rockville, MD 20857

RE: Proposed Rule to Ban Substances in Animal Food [Docket No. 96N-0135]

Dear Madam or Sir:

I am writing on behalf of Farm Sanctuary, a national non-profit organization which works to stop irresponsible agricultural practices.

While we commend the Food and Drug Administration (FDA) for addressing the risk of transmissible spongiform encephalopathies (TSEs) spreading in the U.S., we write today because we believe the agency is taking inadequate action to ameliorate this risk.

RECOMMENDATIONS:

As we have previously stated, we believe it is important to rethink the efficacy of using rendered products in poultry feed, especially since poultry litter is often used in cattle feed. We believe the feed ban should apply to protein recycled through poultry and then fed back to ruminants.

We appreciate the agency's recent proposal to prohibit a broader range of animal proteins from being fed to ruminants. However, we do not believe there is adequate knowledge to justify the agency's excluding "blood and blood products" or "porcine protein" from the ban. A Texas A & M study found that prions are spread from the brain into the bloodstream during mechanical slaughtering procedures. We also oppose excluding "porcine protein" from this ban, especially in light of Dr. Masuo Doi's newly rediscovered study of hogs at an Albany, NY slaughterhouse between 1978 and 1980.

Dr. Doi noticed behavioral symptoms indicating central nervous system (CNS) disorders in slaughterbound hogs, and so he extended his usual two day ante-mortem observation period to three or four days. Based upon his extended examinations, Doi retained over 100 pigs on ante-mortem inspection. Laboratory analysis of pigs retained by Doi raises a very real possibility that U.S. hogs may harbor a TSE of their own. A USDA lab report of one of Doi's hogs (November, 1979) noted:

"Microscopic examination of the barrow tissues revealed an encephalopathy and diffuse gliosis characterized by vacuolated neurons, loss of neurons and gliosis in a confined region (nucleus) of the brain stem (anterior ventral midbrain). Only an empty sometimes divided vacuole was present instead of the normal morphology of a nerve cell. Occasionally a shriveled neuron was seen. According to ...Pathology of Domestic Animals,...'The degeneration of neurons, the reactivity of glia...are the classical hallmarks of viral infection of the central nervous system'...Scrapie of sheep, and encephalopathy of mink, according to the literature, all produce focal vacuolation of the neurons similar to the kind as described for this pig."

There is no reference to BSE (bovine spongiform encephalopathy or "Mad Cow Disease") in this report, because BSE was not discovered until 1986.

INSUFFICIENT INFORMATION IS AVAILABLE TO COMBAT TSE IN THE U.S.:

We believe that current surveillance efforts, including slaughterhouse inspection procedures, are inadequate to detect CNS disease in farm animals. This belief is supported by Dr. Doi's experience.

When Doi extended his ante-mortem observation period to look more carefully for CNS symptoms in pigs, the condemnation rate for CNS rose dramatically. In fact, the slaughterhouse where Doi conducted his observation accounted for more than 70% of all pigs condemned for CNS disease throughout the U.S. during the same time period.

In addition to pigs, other farm animals entering the human food supply may be afflicted with CNS diseases. I have personally visited several slaughterhouses which slaughter downed animals (i.e. animals too sick to stand), and I have been struck by the minimal inspection at these facilities.

Despite the fact that downed animals are considered "suspect" and thus subject to additional observation, ante-mortem inspection of downed animals commonly takes less than 10 minutes. It would be very difficult to identify CNS symptoms in this amount of time, especially since a downed animal's state of immobility makes identifying CNS symptoms even more difficult.

HUMAN CONSUMERS AT RISK:

Every year, tens of thousands of downed cattle, along with countless incapacitated pigs and other farm animals, are slaughtered for human food at U.S. slaughterhouses. These animals are not adequately examined for CNS disease. The reason for the animals' debilitated condition is typically unknown, and we are gravely concerned that some of these animals may be afflicted with a TSE.

If TSE infected animals are being killed and used for human food in the U.S., the consequences could be devastating. We cannot afford to take this risk.

Thank you very much for you concern and thoughtful attention to this matter.

Sincerely,

Gene Baur (formerly Bauston) ,
Executive Director
Farm Sanctuary, Inc.