From: Eric Jonas [EricJ@peta.org] Sent: Tuesday, October 12, 2004 12:59 PM To: fdadockets@oc.fda.gov Subject: People for the Ethical Treatment of Animals; Comments for Docket No. 2004N-0081 RIN-0910-AF47 October 11, 2004 Division of Dockets Management Docket No. 2004N-0081 5630 Fishers Lane Rm. 1061 Rockville, MD 20852 Re: Docket No. 2004N-0081 To Whom It May Concern: People for the Ethical Treatment of Animals (PETA) is an international nonprofit organization with more than 800,000 members and supporters dedicated to ending animal suffering. Please accept the following comments on behalf of our members regarding the proposed rule on “Use of Materials Derived From Cattle in Human Food and Cosmetics,” as described in a Federal Register notice dated July 14, 2004 (DOCID: fr14jy04-9). In the notice, “nonambulatory disabled cattle” are defined as “cattle that cannot rise from a recumbent position or that cannot walk, including, but not limited to, those with broken appendages, severed tendons or ligaments, nerve paralysis, fractured vertebral column or metabolic conditions.” As made abundantly clear, there is ample evidence showing that downed cattle have a greater incidence of bovine spongiform encephalopathy (BSE) than ambulatory cattle due to the fact that cows afflicted with BSE are more likely to go down than other cows. The studies undergone in the European Union and Switzerland mentioned in Section H of the Supplementary Information in the notice demonstrate this fact very well. Because this makes the products of nonambulatory cattle a potential avenue by which humans could become afflicted with the fatal variant Creutzfeldt-Jacob disease (vCJD), the presence of products of nonambulatory cattle in commodities is a serious human health concern. Moreover, downed animals suffer greatly on factory farms and at slaughterhouses. Since they cannot move, they often die agonizingly just a few feet from feed and water troughs. And when taken to slaughter, they are often excessively prodded, hoisted and dragged by the leg or neck, or cruelly pushed by tractors and forklifts towards the killing floor. As a result of this inhumane handling, downed animals incur broken bones, torn tendons and lacerations in addition to the injuries and illness they already suffer from. To make matters worse, most downed animals are fully conscious during the process. We are encouraged by the FDA’s commitment to make sure that the products of nonambulatory cattle be declared unsuitable for use in human food or other products, such as cosmetics, both to improve human health and to decrease animals suffering. On behalf of our members, we ask that this measure remain in place. We also respectfully request that the following recommendations be enacted in the final rule: Prohibit downed cattle from entering the food supply for animals as well as humans In addition to prohibiting downed cattle from becoming food for humans, the final rule should also not allow products of nonambulatory animals to be fed to farmed animals, companion animals or any other animals. Allowing potentially diseased animal products to become food for other animals poses potential health risks to humans and all other animals. A recent World Health Organization statement stipulates that that “All countries… must exclude tissues that are likely to contain the BSE agent from any animal or human food chain.” (emphasis ours). Prohibit specified risk materials from cattle of all ages from entering the food supply We encourage the FDA to prohibit Specified Risk Materials from cattle younger than thirty months of age to enter the food supply. The Federal Register notice states that in both the UK and in Japan the presence of BSE in cattle younger than thirty months of age has been confirmed on several occasions. It is also noted that cattle as young as twenty and twenty-one months of age have been found to have BSE. Because of this, it seems only responsible to require that the Specified Risk Materials of these cattle be treated no differently than those from older cattle. Prohibit all nonambulatory animals, not just cattle, from entering the food supply The American public would surely agree that allowing nonambulatory, potentially diseased animals, or parts of these animals, into the food supply would pose an additional, avoidable risk to human health—especially with other forms of spongy brain diseases having been found recently in various animals in North America, including in sheep, deer, and elk. Prohibiting all downed animals from entering the food supply (including as food for farmed and companion animals would also ensure that downed animals other than cattle—who are just as capable of suffering through the horrors of being kept alive with broken bones, severe injuries, or debilitating illness—do not suffer needlessly. Restrict the feeding of protein derived from mammalian tissues to all farmed animals Spongy brain diseases have been found recently in several species of animals in North America, including deer, elk, sheep, cattle and humans. According to the WHO, materials which are at risk for carrying the agents of spongy brain diseases in any form are not to be present in the food for any animals. The presence of mammalian protein in the food of farmed animals therefore presents an easily avoidable and unnecessary risk. Keep Specified Risk Materials out of all commodities over which you have jurisdiction We support the FDA’s commitment to keeping Specified Risk Materials out of human food, dietary supplements and cosmetics. For safety and consistency, the FDA should similarly ensure that Specified Risk Materials be prevented from entering other products regulated by your agency, such as medical drugs of all varieties and foods for farmed and companion animals. It is essential for human and animal health that the FDA eliminate as many potential paths of spongy brain diseases as possible. In summary, we are requesting that the final rule prohibits the inclusion of any products or derivatives of nonambulatory animals of any species into any food or other products, including food, dietary supplements, cosmetics and drugs for humans as well as food and other products for farmed animals. We recommend that the FDA cease to determine whether certain body parts are Specified Risk Materials based on the age of the animal being slaughtered, and treats all such materials as equally dangerous, regardless of age. It is also necessary that no mammalian-derived protein enter the food supply of any farmed animal. We believe that these steps will ensure a significantly higher degree of prevention of the spread of the various spongy diseases than is presently provided by the rules as proposed in the Docket. Finally, we strongly urge the FDA to continue prohibiting the use of nonambulatory cattle in any products it regulates. We appreciate the opportunity to comment on this very important issue. Sincerely, Eric Jonas, Assistant Campaigner International Grassroots Campaigns Department