From: Bernie Shire [bfshire@aamp.com] Sent: Tuesday, October 12, 2004 4:02 PM To: fdadockets@oc.fda.gov Subject: Docket No. 2004N-0081 (RIN-0910-AF47) October 11, 2004 Department of Health & Human Services Food and Drug Administration (FDA) Division of Dockets Management 5630 Fishers Lane, Room 1061 Rockville, MD 20852 RE: Docket NO. 2004N-0081: RIN-0910-AF47: Use of Materials Derived from Cattle in Human Food and Cosmetics; and Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material from Cattle; Final Rule and Proposed Rule The American Association of Meat Processors is submitting the following comments on two issues: the complete ban on the use of all non-ambulatory disabled animals; and the complete ban of the use of the small intestine from cattle of all ages, and the labeling of the intestines as a Specified Risk Material, particularly in beef casings that are used in sausage and other meat products. AAMP Objects To Complete Ban on Non-Ambulatory Cattle AAMP believes that the complete ban on the use of non-ambulatory disabled cattle as a result of the discovery of a single cow with BSE in Washington State in December, 2003, is not justified. The Agency has levied this ban on all cattle that would enter the food chain, including animals that are under USDA, Aequal to@ state program inspection, and custom slaughter and processing, animals that are not turned into meat to be sold wholesale, but are slaughtered and processed for the animals= owners. The Association can understand that FDA is following USDA in placing restrictions on cattle that exhibit central nervous system (CNS) disorders and other illnesses. But AAMP cannot see or buy the reasoning to place these same restrictions on animals that have injuries such as broken extremities. It is impossible to see any food safety issue connected with animals that cannot walk because they have suffered broken legs or pelvic problems due to birthing. There is no scientific basis or need for such a policy. This is particularly true when animals suffer broken appendages due to injuries that occur in feedlots, in trucks in which they are being transported to slaughter, or to other locations. There is no way to justify the banning of such animals for slaughter just because the injuries took place before ante mortem inspection. An animal that suffers an identical injury after ante mortem inspection on the way to the box is deemed fit for slaughter when presented. Yet there is no difference in the injury to the animal. There is no scientific documentation or evidence for FDA to make this distinction. While a good case could be made for not allowing animals suffering from central nervous system (CNS) disease into the human food supply, there is no way to make a similar argument for animals that have suffered physical injuries, such as broken legs. But there is a solution to this problem that makes much more sense than the total downed cattle ban. Why not allow slaughter plants to test their cattle for BSE and hold them until they get the results of their tests? In the past, there has been a limited amount of testing of animals for BSE B about 20,000 animals annually, with a goal of 40,000 animals. Yet the Department of Agriculture re-designed its testing program, to greatly increase the number of animals to be tested over the next 12 to 18 months to about 268,000 annually. Most of these animals will be those that are already dead or are dying. About 20,000 will be healthy animals who are older (more than 30 months old), and who are headed for slaughter. While APHIS is saying there would be payment for cattle for testing, a spokesman for the Agency said there is no indication as to how much would be paid per animal, or an overall figure from the USDA budget. But if testingBandBholding for BSE were to be allowed, in the end, it will cost the public less in the marketplace. If the test comes back negative, it won=t result in an animal thrown away. If cattle are destroyed, thrown away for no reason, that will cost meat processors about $1,000 per animal. There have been some preliminary guesses as to what the ban on non-ambulatory animals will cost. An economist for the National Cattlemen=s Beef Association puts the cost of the ban on downer animals at $55 million, not including those that would normally have been condemned due to disease or other maladies. The rule prohibiting specified risk materials (SRMs) for animals over 30 months from USDA is estimated to cost between $17 million and $59 million, while the cost of removing these materials is probably $100 million more. So we=re already over $200 million. But we think this is a gross underestimate. In Pennsylvania alone, there is thought to be 25,000 downers a year processed. At a cost of $1,000 an animal, this would be a loss of $25 million in just one state. Slaughter Ban will Result in Fewer AGood@ Tests for BSE The basis for USDA=s BSE testing program, which FDA seems intent on following, had been that non-ambulatory animals with the greatest chance of having the disease are brought to the slaughterhouse to be killed, and then tested. AAMP believes the interim final rule preventing slaughtering of all non-ambulatory animals for food purposes will result in fewer animals being tested for BSE, especially those with the greatest chance of being infected with the disease. The result will be that there will be very little chance of finding animals that might have BSE. The fact that non-ambulatory cattle were being brought to slaughter in the first place, as well as undergoing tests for BSE, had actually helped USDA to find animals that might be sick and not be fit to use as food. The likelihood of animals undergoing tests for BSE back on the farm or ranch, or at the rendering plant is very slight. If the case involving the cow with BSE in Washington State is a good example, we don=t think that producers want to put themselves in the position of having an animal tested there, with a tentative or a definite positive and face a potential Adepopulation@ of their entire herds. USDA should allow cattle to be tested for BSE at the slaughter plant, so that a lot of money won=t be wasted, or lost by the animal=s owner or the slaughter plant, and FDA should support such a policy. As far as we can determine, there is no money in federal budget to compensate slaughterers, processors or producers for animals that can no longer be sent to slaughter because they are non-ambulatory or because they exhibit signs or symptoms of central nervous system (CNS) disease. If there is no compensation for these animals, AAMP is concerned that if no compensation or indemnification is offered, non-ambulatory cattle farms will Afind their way@ elsewhere for burial, without, of course, being tested for BSE. In fact, even if compensation would be offered, we are concerned that non-ambulatory cattle would still be destroyed, so producers may seek to avoid the bad publicity from finding a BSE-infected animal. Restrictions on Custom Animals Can=t Be Defended AAMP also believes that the restrictions being put on using non-ambulatory injured animals in custom slaughter and processing cannot be defended. Again, there are no reasons for this prohibition that can be argued scientifically. According to USDA, the policy against using custom non-ambulatory injured animals in the food supply is based on the adulteration provisions in the Federal Meat Inspection Act. But custom animals are also exempt from the provisions in the Act requiring ante mortem and post mortem inspection. There is no reason for FDA to follow along with that same policy for the products that it regulates. At the same time, a custom-exempt animal, raised by a farmer and brought to a custom-exempt establishment for slaughter or processing, still belongs to the farm, not the establishment. The cattle cannot be condemned because it was injured on the way to the slaughterhouse. This policy would also seem to raise a constitutional issue as to whether the government can confiscate the farmer=s property due to this reason. Also, in designated states, there hasn=t been good communications between Department of Agriculture and custom-exempt plants. There are two kinds of custom-exempt plants: those who also do some slaughtering and processing under inspection, and those who don=t. In the case of custom plants that have no connection to inspection, the Agency hasn=t updated these plants as frequently as state inspection programs do with Atheir@ custom plants. The federal agency hasn=t told custom plants about the ban on the slaughter of non-ambulatory animals for food purposes to the same degree that state inspection programs have. So we wonder who would decide if an injured cow was adulterated, and how would it be decided? AAMP believes that the Agency would have problems enforcing condemnations of recently injured animals in custom plants in designated states. If USDA continues to insist that the provisions of this interim final rule are also applicable to custom plants, we predict that most injured animals will be slaughtered illegally on farms, under unsanitary conditions, and will hinder, rather than help, public health. In fact, Ashade tree@ slaughter operations are taking place right now. We wonder if the government would accept the practice of all Acustom@ animals being tested, with the cost being borne by the owner of the animal who is paying the slaughter plant who is providing the service in killing and processing it. FDA has also aligned itsself with USDA and has made public statements in defense of the ban on non-ambulatory animals due to: (1) Auncertainty@ about what causes BSE in animals and that purely physical injuries, as well as central nervous system (CNS) can=t be ruled out; (2) a Agreat deal of opposition@ to the use of non-ambulatory animals in the food supply even before the BSE cow appeared on December 23 of last year. FDA says that Congress and consumer activist groups have voiced opposition to using such cattle. It is our feeling that Agency regulations are supposed to be based on comments from stakeholder groups, and not on the Agency=s feelings about what certain members of Congress and consumer groups might Athink@, Abelieve@ or Awant.@ AAMP notes that FDA and USDA are supporting a provision in the Federal Meat Inspection Act that allows animals that have been condemned to be set apart and held for treatment. Under this section of the law, non-ambulatory Abob-veal@, for example, can be retained and warmed up until the animals can walk and then be fit for slaughter. AAMP supports this provision and action by the Agency. Plants Need Financial Reimbursement from Government Our Association is also concerned about the lack of financial reimbursement from USDA, FDA and Aequal to@ state inspection programs to producers, slaughterers and processors who experience economic loss as the result of government condemnation of all non-ambulatory injured cattle. By failing to provide financial assistance to such establishments, the slaughter and producing industries are forced to pay a severe monetary penalty for something that has happened that is beyond the control of the firms that are involved. USDA needs to offer financial reimbursement to cover huge additional expenses that plants are incurring, including additional labor costs, handling of the cattle and storage costs. In the state of Washington, legislation has been approved that would offer temporary business and occupation tax breaks for companies there that slaughter cattle for processing and wholesaling. The same thing should be done across the United States for cattle that are inspected by USDA, state programs, or custom slaughter and processing. Designation of Vertebral Column as SRM not Warranted In its comments, the American Association of Meat Processors raised some concerns about the Agency=s designation of the vertebral column in cattle as Specified Risk Materials (SRMs). Our Association believes that FSIS should remove its designation of the major parts of the vertebral column of cattle as an SRM. As we understand it, the reason USDA made this designation initially is that the dorsal root ganglia of cattle are attached to the bones of the vertebral column, and aren=t removed along with the loosely-attached spinal cord. But setting the vertebral column as an SRM because of the attachment of the ganglia is not justified. In our comments to FSIS, we noted the Agency has the authority to require inspected establishments to fully remove the spinal cord and the ganglia next to it before the carcass leaves slaughter. We think that would be better than declaring the major parts of the vertebral column as inedible. Initially, USDA had published information on its web site indicating that steaks could safely be cut and separated from the major parts of the vertebral column, without contamination of the meat as SRM. At the time, that was the best information available, and the USDA-FSIS Technical Service Center in Omaha, NE concurred with the information. But more recently, FSIS says that steaks should not be cut from the vertebral column. So AAMP, other trade associations and university meat science departments, who initially published the same advice and guidelines, are reevaluating the guidance. But that doesn=t mean we think the USDA advice is correct, or scientifically justified. The Harvard Study said that the estimates are likely to overstate true human exposure because they represent the amount of infectivity presented for human consumption but do not take into account waste or actual rate of consumption. For example, the reported quantity for potential exposure to infectivity in bone-in beef reflects the presence of spinal cord and dorsal root ganglia in a fraction of cuts like T-bone steaks, although the spinal cord and the dorsal root ganglia may never be consumed in these cuts of meat. Seven years ago, Great Britain banned bone-in beef after studies indicated that in experimentally-inoculated cattle, the dorsal root ganglia contained the prion that is thought to cause BSE. But two years later, Britain lifted the ban on the sale of bone-in beef because scientists researching how the disease is transmitted concluded that the potential risk to humans from bone-in beef was insignificant. The Harvard study also reported that bone-in beef was a less-likely route for human exposure to BSE. What USDA is saying about this issue is quite unclear and confusing. The elimination of the use of backbones in ground bones will reduce by 50 percent on average the production of ground bones by companies that do this work. Eliminating the use of neck bones for commerce is also costly to companies that are involved in this processing. Why Are Small Processors Forced to AInspect@ Packers? The American Association of Meat Processors had also expressed concerns about USDA policy that is forcing further processors to take steps to make sure that packers and slaughterers are complying with the interim final rules on BSE. According to the way the regulation is written, it is against the law for a packing or slaughtering plant to sell product containing Specified Risk Materials (SRMs) unless the product is marked that it contains such materials, and that there is a means for them to be removed. So it still makes no sense that further processors, including many AAMP members, buy USDA-inspected meat with the mark of inspection on it, and then have to face the possibility that FSIS would mark the product as being Aover 30 months of age@ if the processing plant can=t obtain verification letters. The Agency is directing these processors to obtain verification letters from packers, the same as when processors were forced to verify that suppliers were complying with the E. coli O157:H7 regulations by having verification letters, even though the product carried a mark of inspection. This inspection mark on a meat product says that it has been inspected by a USDA inspector and Apassed,@ which means that the product was produced in accordance with the regulations published by FSIS. So, what is the point of having the mark of inspection if it doesn=t mean what it says it does? There is no justification for requiring the mark of inspection to be Averified@ by a letter stating that the supplier followed the USDA meat inspection regulations. Mark of Inspection Should Not Be ATentative@ AAMP took issue with this policy during one of USDA=s five small/very small plant BSE seminars this past winter when the issue was raised by FSIS policy staff. Dr. Daniel Engeljohn, FSIS Executive Associate for Policy Analysis and Formulation, said that the USDA mark of inspection on some products the Department inspected can be Atentative.@ The new definition of the mark of inspection as Atentative@ came in response to a question posed by AAMP concerning letters processors are being asked to provide from suppliers indicating that the products they receive contain no SRMs. While Dr. Dan Engeljohn from said this policy is necessary because a lot of product over 30 months of age is being shipped from packers to further processors, it is our feeling there is very little over-30-month bone-in product being moved. It seems to us this debate is a way for USDA to avoid the main issue. If the large packers and suppliers are following the rules and the product is passed, then the mark of inspection should be applied, and letters of guarantee would not be needed. In addition to raising this issue in our comments on the interim final rulemaking, AAMP has also asked for a written explanation of what should be an USDA proposal prior to implementation, with a written explanation from FSIS about it, not as a policy change or public policy already carried out. FDA should not follow along and mimick this USDA policy. Carcasses with SRMs Should Not Leave Establishments It is our opinion that carcasses containing SRMs should not be allowed to leave an official slaughter establishment, especially with the marks of inspection on them. That policy is contrary to the whole idea of meat inspection, and raises questions about the significance of the marks of inspection. Does Ainspected and passed@ mean anything anymore? If it doesn=t, then USDA could save inspected establishments a lot of headaches, and the taxpayers of the United States a lot of money, by stopping meat and poultry inspection. The current USDA policy that allows official slaughter establishments to ship carcasses containing SRMs to official processing establishments, under the assumption that the further processing plants will remove the SRMs, is wrong. Since SRMs can=t be eaten under USDA regulation, a carcass containing inedible parts should not carry inspection marks. Otherwise, the confidence of the American public in marks of inspection as an indicator of meat safety, will deteriorate. This kind of vague inspection measure could compromise public health protection. There should be a regulatory provision that would prohibit the shipment of cattle carcasses containing SRMs to another inspected establishment. This would prevent the possibility of SRMs reaching consumers due to error or negligence at a processing plant. We also told FSIS previously that the Agency should also insure that carcasses containing SRMs are not shipped to uninspected establishments, such as retail stores or restaurants. There is nothing in the final rule mentioning such a prohibition. Some FSIS officials have made comments that carcasses containing SRMs could be sent to retail outlets, who would be responsible for removing them. We don=t think that such an expectation is realistic. A huge field force of compliance officers (which doesn=t exist) would be needed to enforce such action by retail stores or restaurants. The prohibition should be included in the final rulemaking. AMR Limitations Hurt Plants The limitations that USDA has placed on Advanced Meat Recovery, such as eliminating the use of backbones in this process, has hurt meat plants that carry it out, including a number of small meat establishments. On average, the amount of finely textured beef (FTB) produced by these plants has been reduced by 65 percent because of the limitations placed by the Agency. We will talk about the cost to such plants in our separate comments on the FSIS Preliminary Regulatory Impact Analysis (PRIA). Concerns About Rulemaking on BSE AAMP also has concerns about the rulemaking process. We notice that notices are more detailed and lengthier than the interim final rules on BSE. Notices carry the weight and power of regulatory requirements. They are only good until early 2005. But we are concerned that for years to come, inspectors will equate them with regulations. Also, interpretations and explanations in notices often go far beyond the regulations, as in the case of the notices relating to BSE. The rulemaking should be more inclusive, that would contain all the permanent regulatory provisions. This approach would eliminate the negative impression that internal documents, such as notices and directives, are being used to circumvent the open notice-and-comment rulemaking process. Concern About the Complete Ban of the Small Intestines In this proposed rulemaking, FDA bans cattle materials from not only the distal ileum of the small intestine of all cattle, but the entire small intestine itself. There is no reason to do this, because only the distal ileum is associated with BSE as a risk material, in the view of numerous international regulatory authorities. But both FDA and USDA ban the entire bovine small intestine, because in the opinion of both agencies, it would be "easier" and "safer" to do that than to take a chance that part of the animal organ might get into product. The American Association of Meat Processors would also like to ask the Food and Drug Administration why there is also a policy banning the importation of the beef casings from countries that are considered to be "BSE free". We understand that instead a political decision has been made to continue the ban until at least after November 2, the date of the general election. Decisions concerning the banning of cattle material should be made based on real science, not "political science." This policy is hurting the small meat processing industry severely, and needs to be changed as soon as possible. Plants that would be especially affected negatively by this FDA policy include those who manufacture sausage and similar products that are enclosed in beef casings. This policy will hurt plants that make such products as ring bologna, knockwurst and other kinds of sausages, especially speciality items. The small plants will be affected severely, because they are the only kinds of establishments that make many of these products. We appreciate the opportunity to comment on these FDA interim final rules concerning BSE. Sincerely, Bernard F. Shire Director, Legislative & Regulatory Affairs American Association of Meat Processors PO Box 269, One Meating Place Elizabethtown, PA 17022 Tel: 717 367 1168 Fax: 717 367 9096 E-mail: bfshire@aamp.com _____ This mailbox protected from junk email by Matador from MailFrontier, Inc.