From: Mark Myers [Mark.Myers@nbyprod.com] Sent: Friday, August 06, 2004 9:33 AM To: fdadockets@oc.fda.gov Subject: "Docket No. 2004N-0264 National By-Products, LLC PO Box 615 Des Moines, IA 50303 515-288-2166 July 30, 2004 Docket No. 2004-N-0264 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 We are writing in response to Docket No. 2004-N-0264 and the FDA's (Agency) solicitation for comments on the Advanced Notice of Proposed Rulemaking, "Federal Measures to Mitigate BSE Risks; Considerations for Further Action". National By-Products, LLC (NBP) is one of the largest dead stock renderers in the United States. Almost all of our finished rendered proteins contain some ruminant material so are considered restricted materials and are governed by the present FDA feed rule, 21 CFR 589.2000. The following comments represent our current thinking and recommendations regarding the questions posed by the Agency as published in the Federal Register, Volume 69, Number 134, on July 14, 2004. We have also included a response to a question posed by the Animal and Plant Health Inspection Service (APHIS) where it seemed appropriate. 1. Would there be value in establishing a specialized advisory committee or standing subcommittee on BSE? NBP believes establishing a standing subcommittee on BSE makes sense in light of the recent discovery of a BSE case in the US and the more aggressive BSE surveillance initiative. A standing subcommittee would provide ready expert industry and academic advice as issues emerge during this dynamic period of surveillance and regulatory adjustments. NBP encourages the Agency include an individual from the independent rendering industry who can provide that type of expert advice. 2. What data or scientific information is available to evaluate the IRT recommendation described above, including that aspect of the recommendation concerning what portion of the intestine should be removed to prevent potentially infective material from entering the human food and animal feed chains? No comment. The US cattle packers have the expertise to best answer this question. 3. What information, especially scientific data, is available to support or refute the assertion that removing SRMs from all animal feed is necessary to effectively reduce the risks of cross-contamination of ruminant feed or of feeding errors on the farm? What information is available on the occurrence of on-farm feeding errors or cross contamination of ruminant feed with prohibited material? Removal of SRMs is a necessary supportive restriction when there has been sufficient failure in the primary restriction, that being the prevention of feeding ruminant materials back to ruminants. But contrary to this notion is the Agency's own record of inspections that demonstrate the animal feeding industry has an extraordinarily high compliance rate with the Feed Rule (21 CFR 589.2000). By analogy, we argue that if the suspenders are working there should not be a need to also wear a belt. Nevertheless, if the Agency is compelled to ban SRMs from animal feed, we suggest the Agency consider steps to minimize the volume for disposal. This would help sustain a rendering infrastructure that is necessary to help government conduct BSE surveillance, protect the environment, and safeguard animal and human health. These steps are discussed in our responses to questions #7 and #22. 4. If SRMs are prohibited from animal feed, should the list of SRMs be the same list as for human food? What information is available to support having two different lists? As APHIS suggests, a staged approach may be necessary to permit the development of an infrastructure capable of disposing of the raw materials from which prohibited finished proteins are generated. In order to further minimize the quantity of materials requiring alternative disposal while still reducing risk to a minimum, focus should be directed towards removing only those materials carrying the greatest potential risk. It is well accepted that the brain and spinal cord carry about 90% of the potential infectivity while the trigeminal ganglia, dorsal root ganglia, and eyes carry the other 10%. The small intestine and tonsils carry less than 0.5%. Nevertheless, the Agency has suggested the removal of proteins derived from the small intestine and tonsils of cattle of all ages from animal feed. NBP suggests that proteins derived from these low-risk materials from cattle under 30 months of age be permitted in feed for the following reasons: a. There is very little potential infectivity associated with proteins from these materials especially after rendering. b. These animals were all born well after good compliance with the FDA feed rule had been established and therefore should have experienced little to no exposure to the BSE agent even if present in the US at the time. c. It will reduce the amount of SRMs from slaughter cattle requiring alternative disposal by more than half (Table 2, Appendix A, FDA Environmental Assessment, IFR on Use of Materials Derived from Cattle in Human Food and Cosmetics). 5. What methods are available for verifying that a feed or feed ingredient does not contain SRMs? Although a testing procedure exists for verifying whether central nervous system (CNS) tissue is present in raw materials prior to rendering, it is not known whether the ELISA based test could detect these same materials after they have been cooked during rendering. In addition, not all SRMs contain CNS tissue (small intestine and tonsils). However, if small intestines and tonsils from cattle <30 months of age are not included in the list, that only leaves those from cattle >30 months of age. This would represent only a small percentage of their SRM mix. With this approach the CNS tissue test may be an effective verification tool. If not, verification can be accomplished by real-time inspection of the process of SRM removal. Just as USDA employees currently inspect slaughter processes and the resulting products, the process of SRM removal could be inspected as well. 6. If SRMs are prohibited from animal feed, what requirements (labeling, marking, denaturing) should be implemented to prevent cross-contamination between SRM free rendered material and material rendered from SRMs? If SRMs are removed, NBP agrees that a SRM containing rendered proteins should be labeled or dyed, but in a fashion that will not interfere with their final use. For example, if the proteins were to be combusted for energy generation, dyes should not interfere with that use. However, if they were to be used to generate plastic films or adhesives, a dye might hinder those processes. It would also be useful to denature SRM-containing raw material to help prevent cross-contamination prior to rendering. But the denaturant should only impart a color change that affects the protein meal and not the fat once rendered. A noticeable color change to the fat would stigmatized it and result in a reduced value in the market place, contrary to the Agency's intention to not restrict the trade of fat resulting from an SRM source as long as it contains less than 0.15% hexane insoluble impurities. At this time, NBP is not aware of a source of denaturant with those properties. 7. What would be the economic and environmental impacts of prohibiting SRMs from use in all animal feed? The economic and environmental impacts will be influenced by at least a couple of factors. First, will the FDA permit independent renderers to remove SRMs from the cattle mortalities and non-ambulatory disabled cattle and use the remaining materials to generate feed ingredients? If they allow SRM removal, only a small proportion of those cattle carcasses would be considered SRMs. Within the Appendix A of the FDA's Environmental Assessment for the Interim Final Rule on Use of Materials Derived from Cattle in Human Food and Cosmetics, July 9, 2004, they estimated the total amount of SRMs potentially generated from slaughter cattle, dead stock cattle, and non-ambulatory disable cattle to be 2,115,194,000 pounds. The FDA also estimated this material would yield 25% protein and 25% fat upon rendering. This would amount to 528,798,500 pounds each of protein meal and fat. As long as the rendered fat contained less than 0.15% hexane insoluble impurities, it could be traded normally. However, the protein meal would represent lost revenue of $66 million to the industry (@$250/ton). At least in the short term or until new uses are developed, this quantity of protein meal would most likely be disposed of in suitable landfills. Sparks Company (2001) estimated the average tipping fee and transportation costs to be $75/ton. So in addition to the loss in revenue, the industry would also incur an additional $20 million in tipping and transportation costs for a total loss of $86 million. If renderers are not allowed to remove SRMs from cattle mortalities, they will most likely suspend the collection of these carcasses so they must be included in any discussion of the economic and environmental impacts. In Appendix A the FDA estimated an annual weight of 5,581,250,000 pounds of deads and downers. The FDA also estimated a 25% yield each of protein meal and fat on this material resulting in 1,395,312,500 pounds of each generated. This represents $174 million in potential lost protein revenue and $251 million (@$0.18/lbs) in lost fat revenue to the industry. In addition, the chance to salvage hides from these carcasses has also been lost. The FDA estimated the annual number of deads and downers to be 4,465,000 cattle. Approximately 60% of the hides associated with these carcasses can be salvaged. This amounts to another $96 million in lost revenue using an average value of $36.00 a hide. SRMs removed at slaughter may still be rendered to recover the fat. If so, only the protein meal will result in another $44 million in lost revenue from the 1,423,044,000 pounds of SRMs. Finally, the landfill and transportation cost to dispose of the protein meals generated from the SRMs adds another $13 million. Conversely, if the SRMs are not rendered but disposed of directly in landfills it would add $53 million in transportation and tipping fees. The total economic impact of not allowing the removal of SRMs from dead stock and non-ambulatory disabled cattle including lost revenue, tipping fees, and transportation would range from $578 million to $618 million compared with $86 million when SRM removal is allowed. In addition to the economic impact, the disposal of non-rendered dead stock cattle, non-ambulatory disable cattle, and SRMs removed at slaughter would create a major environmental impact. Placing these infectious tissues in landfills will greatly increase the amount of infectious waste received by landfills. Haas (1996) estimated the primary load of infectious waste received in landfills was 126,500 tons per year composed primarily of human feces from disposal diapers and pet feces. As indicated earlier, if the removal of SRMs from deads and downers are not allowed, renderers will likely not collect these tissues. If they were all disposed of in landfills this would amount to 3.5 million tons annually. If this material could be disposed of in any landfill, it would increase the load of infectious waste by over 27 times. By comparison, if SRMs could be removed from deads and downers, this amount would be reduced by 70% to 1.06 million tons per year. In actuality, the number of landfills capable of handling this material would be limited since they would have to be compliant with 40 CFR Part 258 requirements. This includes requirements to construct disposal cells separated by heavy poly liners and leachate collection systems. More recently, the EPA published recommendations for the disposal of CWD carcasses and wastes (April 6, 2004). NBP anticipates the EPA would view wastes from SRMs, deads, and downers similarly. For these wastes the EPA recommends that the leachate be recycled where practical and use a foot of absorbent material to cover every layer that is two carcasses deep. This requirement would expand the weight of 3.5 million tons to 4.66 million tons or 3.64% of the total solid waste currently placed in landfills, (EPA, 2002). Other disposal methods such as carcass abandonment are not attractive and in most States illegal for obvious human and animal health reasons. On-farm burial is limited in most States by the quantity one can bury per acre as well as the depth and location in relation to surface and ground water sources. Composting has not proven to be a good disposal option either. While a well-controlled composting process may destroy many of the conventional pathogens present in these materials, conditions are not extreme enough to eliminate spore forming bacterial and there is little information to suggest composting reduces the level of BSE infectivity. In the poorly managed composting operations that NBP observes everyday, few if any provisions are made to control seepage or run-off from the piles or access by scavenger. In addition, the volume of compost created is much more than the original volume due to the amount of carbon material that must be added. Using composting guidelines published by the National Pork Producers Council, the combined amount of composting and carbon material storage space needed to compost 3.5 million tons of deads, downers, and SRMs would amount to 4,480,000 acres or 7,000 square miles. This would cover 20% of the state of Iowa in a layer five feet deep. That leaves incineration and chemical digestion as acceptable means of disposal. While both have been shown to eliminate conventional pathogens and TSEs, they are currently limited in their capacity to handle such volumes. Both are relatively expensive in relation to rendering and both create waste streams requiring disposal. Incineration at least holds the promise of generating some value in the form of steam or electricity. However, there is little interest on the part of cement kiln operations or municipal power generators to utilize raw or cooked animal tissues. Any interest they do have is contingent upon receiving excessive tipping fees of about $100/ton (Animal Tissue Biomass Workshop, Penn State, July 22, 2004). NBP views the need to uniformly regulate the disposal of these infectious tissues as a primary issue in our response to the Agency's proposals. To consider expanding the list of prohibited feed ingredients containing cattle material without addressing the disposal of these tissues in their raw form is disingenuous at the least. Further comments regarding a potential remedy can be found in our response to question #22. PLEASE NOTE: Within Appendix A of the FDA's Environmental Assessment for the Interim Final Rule on Use of Materials Derived from Cattle in Human Foods and Cosmetics, July 9, 2004 - The information provided states that there are 4,465,000 cattle mortalities per year, consisting of deads and downers with an estimated weight of 5,581,250,000 lbs. The information further states that the rendering industry collects 768,000 of these cattle mortalities weighing 960,000,000 lbs., leaving 3,697,000 head or 4,621,250,000 lbs. to be disposed of my some other LEGAL method of disposal. Based on the information provided in Appendix A, the 960,000,000 lbs. collected and processed by renderers would yield 25% animal proteins, or 240,000,000 lbs. of MBM. HOW CAN THE AGENCY NARROW ITS SCOPE OF FOCUS on 240,000,000 lbs. of MBM COMING FROM AN INDUSTRY THAT HAS DEMONSTRATED IT IS 99%+ COMPLIANT WITH THE FEED BAN RULE, HAS A PROCESS THAT PROVIDES A REDUCTION IN BSE INFECTIVITY BY 1 to 2 LOGS, ALLOWS THE AGENCY TO MAINTAIN COMPLETE REGULATORY CONTROL, YET TOTALLY DISREGARD WHERE AND HOW THE REMAINING 4.4 BILLION LBS. OF RAW RUMINANT PROTEINS ARE BEING DISPOSED OF? 8. What data are available on the extent of direct human exposure (contact, ingestion) to animal feed, including pet food? To the degree such exposure may occur, is it a relevant concern for supporting SRM removal from all animal feed? No comment. NBP feels the pet food industry has better expertise to answer this question. 9. What information, especially scientific data, is available to show that dedicated facilities, equipment, storage, and transportation are necessary to ensure that cross contamination is prevented? If FDA were to prohibit SRMs from being used in animal feed, would there be a need to require dedicated facilities, equipment, storage, and transportation? If so, what would be the scientific basis for such a prohibition? If FDA were to prohibit SRMs from animal feed and feed ingredients, there would be no need to require the handling of these materials through dedicated facilities, equipment, storage, and transportation. The Agency will have shifted regulatory control from the use and handling of finished feed ingredients to controlling the source of those ingredients. Changing the focus of control should improve the efficiency of control since there will be far fewer facilities and processes to regulate. By this we mean the focus will be on the sourcing of tissues at cattle packing and rendering plants rather than the thousands of feed mills and on-farm feeders. Although not stated in the question, we assume this is in fact one of the intents of the FDA in proposing the removal of SRMs from animal feed. As the rule pertains to rendering, dedicated lines should be defined as the equipment used for receiving, grinding, cooking, pressing, storage, and conveyance of rendered or renderable materials. Separate dedicated lines, such as one used for SRM material and one for SRM-free material should be allowed within the same facility. Closed systems that do not share common equipment should not require additional physical barriers to ensure adequate separation of materials. This approach carries the advantage of using common facilities, utilities, odor control, and wastewater treatment systems to help sustain the current rendering industry infrastructure. Solids recovered from a common wastewater system should be treated as prohibited material. The current FDA "feed rule" (CFR21 589.2000) allows renderers to use an approved clean-out procedure for rendering lines used to produce both prohibited and non-prohibited materials. Most independent rendering facilities in the U.S. employ single processing lines. It is critical FDA consider extending this clean-out option or some modified form of it, for the following reasons: 1. Without a mechanism to safely process both categories of materials, fewer facilities will handle prohibited materials. This will further erode APHIS's access to targeted cattle populations for surveillance. It will also encourage further expansion of the improper and illegal disposal of prohibited materials. Renderers have documented this emerging trend and have provided FDA with this evidence over the past two years. 2. In order for renderers to participate in government sponsored disease eradication efforts, renderers need an approved procedure for converting back to non-prohibited material after processing prohibited materials. A good example is the seasonal opportunity for renderers to participate in the disposal of deer harvested in Wisconsin as a part of that state's strategy to control chronic wasting disease (CWD) in its deer population. 3. A rendering facility that historically processes SRM material and wishes to convert to all SRM-free material needs an approved procedure for doing so. 4. In the event a rendering facility processes material it later learns contains TSE infective material, an approved clean-out procedure is needed to resume production. The recent BSE event in Washington State required such a government approval for two rendering companies. We propose that independent renderers work with FDA through the rulemaking process to reevaluate the currently approved clean-out procedure to develop a Standard Operating Procedure (SOP). This procedure would be implemented by a facility before SRM-free materials could be produced following the rendering of SRMs. A log could be kept that would monitor and document this procedure and be available to the FDA for inspection and review. Although there are relatively few independent rendering facilities in the US, this industry has demonstrated its commitment to mitigating BSE risks by its exemplary compliance with FDA regulatory measures. Therefore, in our opinion, the resources needed for regulatory oversight of clean-out procedures would be minimal. The issue of dedicated transport should be investigated for both raw materials and finished products shipped to and from rendering facilities. The segregation of raw material during collection will be dictated by their source. SRM containing materials should be collected and transported in vehicles that are designed to prevent co-mingling with SRM-free materials. Although these types of vehicles are currently in use by independent renderers, we anticipate a significant increase in the need for more of these vehicles under this scenario. We also anticipate the need to be able to have an approved clean-out procedure. There will be times a vehicle will be used to haul SRM-containing material followed by a load of SRM-free material. Requiring dedicated vehicles for each type of raw material is not economically feasible. A good example for the application of an approved clean-out procedure occurs when a company ships SRM-containing and SRM-free raw materials between two rendering plants. One location processes SRMs and the other SRM-free materials. However, the raw materials collected in the areas surrounding each location will contain both types and must be segregated and hauled to the appropriate location. Therefore there will be transfers of SRMs in one direction and SRM-free materials in the other. An approved clean-out procedure for vehicles will avoid having vehicles deliver loads of one type of material and have to drive back empty rather than with loads of the other type of material. NBP has estimated the costs of requiring dedicated vehicles to handle segregated dead stock cattle and small locker plant cattle offal/bones. NBP's first year capital costs for additional trucks and trailers for dead stock cattle is estimated to be $4.35 million with another $1.86 million for locker plants. The additional operational costs for redundant routes and transfers are estimated at $7.12 million for dead stock cattle and $1.88 million for locker plants. The total first year capital costs for NBP would be $6.21 million with $9.00 million more in operational costs that would reoccur each succeeding year. By our estimates, this would add over $80 per 1000 pound-animal in collection fees to breakeven. NBP has a good estimate of our share of the national quantity of dead stock cattle and locker plant material. Based upon this estimate, we can extend the economic impact we would expect to experience to that for the entire industry. For dead stock cattle we estimate first year capital costs at $200 million and for locker plant materials another $10.3 million. The additional operational costs that would reoccur each year would be $255 million for deads and another $10.5 million for locker plants. These are insurmountable costs in and of themselves, but would be in addition to lost market revenue for some or all of the finished products generated from these materials. Independent renderers would not be able to recover these additional costs through collection fees. So we propose that independent renderers work with FDA through the rulemaking process to develop a SOP for an acceptable clean out of vehicles used to transport SRM-containing material. This procedure would be implemented by the facility before SRM-free materials could be hauled on the same vehicle. This SOP could include the physically washing and visually inspection of vehicles to ensure no carryover of materials. A log could be kept that would monitor and document this procedure and be available to the FDA for inspection and review. The transport of finished rendered proteins by railcar and truck is another issue. The use of dedicated railcars for transporting prohibited proteins is already a common industry practice. However, dedicating trucks for the transport of SRM-containing finished proteins is not economically feasible, logistically practical or environmentally sound. The feed ingredient and agricultural commodity industries use a network of independent trucking firms to transport a variety of bulk commodities throughout North America. The efficiency of this system depends upon the ability to arrange backhauls in close proximity to prior delivery points. The operation of this network is based upon the ability to haul a wide variety of commodities in each truck. This obviously supports the efficient use of petroleum resources and reduces the number of trucks on the nations roadways. The cost of transporting prohibited proteins will more than double if dedicated trucks are required. The current average freight rate for prohibited proteins averages $20 per ton. We estimate most of the SRM-containing rendered proteins would be transported by truck for final disposal. If the entire 3.5 million tons of deads, downers, and SRMs each year were rendered and the resulting 875,000 tons of MBM were transported by truck for disposal, the impact of requiring dedicated vehicles would exceed $17.5 million. Since most independent renderers do not have their own truck fleets for finished products and there would be limited financial incentive for contract haulers to maintain dedicated fleets, renderers would most likely be burdened with the cost of establishing their own private truck fleets as well. An approved clean-out SOP for vehicles is consistent with the FDA's intent of preventing cross-contamination of prohibited from non-prohibited materials without creating a new category of "toxic waste" for the federal government, the insurance world, the transportation industry to deal with. We caution the FDA that requiring dedicated vehicles could result in such unintended consequences as requiring separate DOT placards when hauling these materials, insurance companies disallowing coverage when hauling these products, pollution exclusions kicking in, hazmat teams needing to be involved in clean-up of spills, etc. 10. What would be the economic and environmental impacts of requiring dedicated facilities, equipment, storage, and transportation? See response to question #9. 11. What information, especially scientific data, is available to demonstrate that cleanout would provide adequate protection against cross contamination if SRMs are excluded from all animal feed? Assume the clean-out procedure results in a 5% carry over of potentially infectious tissue into the following SRM-free material. Assume also that although unlikely, the last load of SRMs in the cooker before clean-out contained the tissues from a cow having a full-blown case of BSE with a level of 10,000 ID50. The amount of carry-over would be: 10,000 ID50 x 0.05 = 500 ID50 doses. The 500 ID50 doses are then diluted with the rest of the day's production of SRM-free material of 600,000 pounds that produces 150,000 pounds of MBM. This material is conveyed and then cooled by recirculation in the storage unit. This helps to equally distribute the 500 ID50s throughout the 150,000 pounds of MBM. That results in a concentration of 0.0033 ID50s per pound. If indeed this product was not further diluted by another days production or by inclusion in a feed supplement but fed directly to a dairy cow at two pounds per head per day in violation of the current FDA Feed Rule, the cow would receive 0.0067 of an ID50 dose per day. In other words, the cow would have to consume 300 pounds of this MBM to receive a single ID50 dose. This simple calculation argues that a suitable clean-out procedure can be devised to adequately protect against cross-contamination of SRM-free material with SRMs at the rendering level. 12. What information, especially scientific data, supports banning all mammalian and avian MBM in ruminant feed? See response to question #13. 13. If SRMs are required to be removed from all animal feed, what information, especially scientific data, is available to support the necessity to also prohibit all mammalian and avian MBM from ruminant feed, or to otherwise amend the existing ruminant feed rule? If the potentially infectious tissues in the form of SRMs are removed from all animal feed, the resulting SRM-free MBM will replace the current SRM-containing MBM in the diets of pigs and chickens. With no potential exposure of these animals to the BSE infective agent, the pork or poultry meals created from the rendering of by-products from these animals would also be SRM-free. There would be no risk in continuing the practice of feeding pork or poultry meals to ruminants. To ban the feeding of these meals to ruminants would not be necessary. 14. What would be the economic and environmental impacts of prohibiting all mammalian and avian MBM from ruminant feed? NBP directs the Agency to review the National Renderers Association's comments regarding this question. 15. Is there scientific evidence to show that the use of bovine blood or blood products in feed poses a risk of BSE transmission in cattle and other ruminants? No comment. The blood and plasma producers have the expertise to respond to this question. 16. What information is available to show that plate waste poses a risk of BSE transmission in cattle and other ruminants? The USDA published an interim final rule (IFR) in January of this year requiring the removal of SRMs from human food. The FDA followed by publishing a similar IFR in July. The list of SRMs for removal are those that could potentially harbor the BSE infective agent. Consequently, the remaining cattle meat available for food has little risk of carrying any relevant infectivity. Plate waste would have a similar negligible risk to cattle and other ruminants since it is composed of discarded food that meets the requirements of these two IFRs and was presented to humans for consumption. It is also important to note that used cooking oils collected from restaurants and snack food manufactures by renderers are not plate waste. There is no risk associated with this product since it does not contain any SRMs and should be exempt from the proposed rule. 17. If FDA were to prohibit SRMs from being used in animal feed, would there be a need to prohibit the use of poultry litter in ruminant feed? If so, what would be the scientific basis for such a prohibition? If the potentially infectious tissues in the form of SRMs are removed from all animal feed, the resulting SRM-free MBM will replace the current SRM-containing MBM in poultry diets. With no potential exposure of these animals to the BSE infective agent, the feces and litter generated by poultry fed this MBM would also be SRM-free. There would be no relevant risk of exposure to the BSE agent in continuing the practice of permitting the use of poultry litter in ruminant diets. To ban the use of poultry litter in ruminant diets would not be necessary. 18. What would be the economic and environmental impacts of prohibiting bovine blood or blood products, plate waste, or poultry litter from ruminant feed? No comment. NBP does not have the experience to respond to this question. The blood and plasma producers and poultry producers and processors have the experience to make these estimates. 19. Is there any information, especially scientific data, showing that tallow derived from the rendering of SRMs, dead stock, and non-ambulatory disabled cattle poses a significant risk of BSE transmission if the insoluble impurities level in the tallow is less than 0.15 percent? Both the international organization for animal health (Office International des Epizooties, OIE) and the USDA concur that tallow derived from rendering animal tissues, regardless of its origin, does not pose significant risk of BSE transmission if the insoluble impurities level is less than 0.15%. Article 2.3.13.8 of the OIE Terrestrial Animal Health Code, 11th Edition, 2003, states the for protein-free tallow (having less than 0.15% insoluble impurities) and its derivatives that, "Regardless of the BSE status of the exporting country, Veterinary Administrations should authorize without restriction the import or transit through their territory..." On March 12, 2004, the USDA submitted comments to the OIE supporting this norm by stating, "This standard as it currently exists enjoys widespread international support and use, is accepted by all Member countries, and is supported by science. Epidemiological studies have failed to find any association between the occurrence of BSE and the consumption of tallow by cattle. Also, the BSE-spiked rendering studies show no infectivity in crude unfiltered tallow produced by a rendering procedure that produced MBM with almost as much infectivity as was present in the untreated spiked-materials." There is however, a major issue that must addressed regarding the method for measuring the "hexane-insoluble matter" as stipulated in the FDA IFR for the "Use of Materials Derived From Cattle in Human Food and Cosmetics". The method sited from "Food Chemicals Codes", 5th Edition (2004) is not the method used by the laboratories that service the animal production, rendering, feed production, or oleochemical industries in the US. These labs commonly use the American Oil Chemist Society (AOCS) method Ca 3a-46. The differences between the two methods are substantial. In addition, the method stipulated by the FDA would be burdensome to perform. The FDA stipulated method uses a sample size of 100gm, 1500ml of hexane per sample, and a fritted porcelain filter funnel. The AOCS method requires 2 grams of sample, 100ml of kerosene and a small amount of pet ether, and uses glass-fiber filter paper. Keeping the pores in the porcelain filter funnels from plugging and changing the filtering dynamics from sample to sample is problematic. Commercial labs would be reluctant to use these filters as they would either have to discard and replace them at $120 each or invest the labor to clean and verify their efficiency from sample to sample. In addition, the volume of hexane required per sample is also economically and environmental unsound compared with the volume of solvents required by AOCS method. The increase in the cost of the solvents used in the FDA stipulated method is roughly four times higher. The cost of properly disposing of the solvent wastes is about 15 times higher. We would strongly recommend the FDA reconsider the method approved for measuring insoluble impurities and adopt the AOCS method currently employed by commercial labs and the industry. 20. Can SRMs be effectively removed from dead stock and non-ambulatory disable cattle so that the remaining materials can be used in animal feed...? NBP has supplied frozen meat to pet food canners since the 1960s and the greyhound racing industry since the early '80s. With timely, efficient collection capabilities, NBP is able to salvage suitable meat from cattle mortalities during the cooler seasons of the year. The removal of SRMs take place in NBP pet food facilities that are completely separate from NBP rendering facilities. The major muscle cuts are hand deboned, chopped, and frozen. Other suitable parts of the carcass are converted into mechanically deboned beef (MDB) and frozen. The remaining bones and tissues are sent to inedible rendering. USDA veterinarians inspect these meats and the NBP facilities that produce them. Some of NBP's facilities have been removing brains, eyes, tonsils, spinal cords, and intestines since 1998 at the request of some pet food manufacturers. One facility also removes the vertebral column. Other than during the hottest months of the year, this procedure can be performed. Based upon our experience, NBP could remove the list of SRMs proposed by the FDA from cattle mortalities of all ages. The primary change to our current procedures would be to extend the removal of the vertebral column to all of our pet food facilities. 21. What methods are available for verifying that a feed or feed ingredient does not contain materials from dead stock and non-ambulatory disabled cattle? At NBP's pet food facilities, carcasses are hung individually for processing. SRM removal proceeds in a fashion so as not to cross-contaminate non-SRM materials. Each day's production of chunk meat or MDB is considered a lot and assigned a unique number which identifies all boxes or tubes of each product and their date of production. Quantities of each product are recorded for accurate inventory control. Inventory and shipping records document the movement of both SRM and SRM-free materials. Such an arrangement lends itself to inspection for verification of compliance much like that occurring at USDA inspected cattle slaughter facilities. NBP would not be opposed to more frequent inspections by USDA veterinarians if deemed necessary by the FDA. 22. What would be the economic and environmental impacts of prohibiting materials from dead stock and non-ambulatory disabled cattle from use in all animal feed? Historically, NBP has not handled non-ambulatory disabled cattle. So other than the following comment, we will restrict our discussion to dead stock cattle. Following the prohibition of non-ambulatory disabled cattle from human food by the USDA earlier this year, it was assumed that independent renderers would begin receiving them and the USDA would have access for BSE surveillance. NBP has received one animal thus far in 2004. This should alert the Agencies that similar restrictions to prohibit the use of the entire dead stock carcass in feed will create the same unintended consequence. Without the ability to salvage most of the value of dead stock cattle by removing the prohibited materials, most independent renderers will likely discontinue collection service. This will greatly reduce access to cattle mortalities for BSE surveillance and aggravate the loss of regulatory control over the disposal of these infectious tissues. If renderers are not allowed to remove SRMs from cattle mortalities the value of entire carcass would be lost. As illustrated in our response to question #7, this would represent a loss of $174 million in protein value, $251 million in fat value, and $96 million in hide value for a total of $521 million in lost annual revenue to independent renderers. Without dead stock collection service, the owners of these carcasses must find alternative methods of disposal. Alternatives such as carcass abandonment, on-farm burial, composting, and incineration appear to offer cheaper means of disposal. Unfortunately, they are cheaper because they do not offer the same level biosecurity, environmental protection, and traceability that rendering disposal does, as well as being largely unregulated or under-regulated. NBP views the poor regulation of disposal of these infectious tissues as a serious threat to animal and human health and the environment when dead stock collect ceases. In attempts to remedy this emerging threat over the past two years, NRA members alerted the USDA, the FDA, State Departments of Agriculture and Departments of Natural Resources, as well as the US Animal Health Association (USAHA) to this potential outcome. NRA offered the following resolution in October 2002 to the Food Safety and Feed Safety Committees of USAHA: That APHIS and/or other appropriate federal agencies address this sanitation issue and develop 1. Regulations requiring that raw animal by-products and mortalities be properly disposed of by federally licensed operators. 2. Federal licensing standards requiring that all options used for the disposal of animal by-products and mortalities meet uniform levels of traceability, biosecurity, and environmental protection. In a further attempt in January 2004, NBP and Darling International provided the USDA and the FDA with a model interim final rule. This model IFR provided the Agencies with a roadmap for federally regulating the safe collection, processing, and final disposition of cattle materials in the event they were deemed unsuitable for inclusion in animal feed. Requiring safe and responsible disposal of these materials in their raw form is consistent with the Agencies' stated objective of reducing the risk of human and animal exposure to the agent responsible for BSE in these same materials after they have been rendered. It would also help sustain the rendering infrastructure the Agencies have depended upon daily for decades to break the disease cycle of conventional pathogens inherent in these tissues. If the FDA prohibits SRMs in animal feed, APHIS must prohibit their indiscriminant disposal throughout the environment. In summary, unless independent renderers are able to salvage enough value from the carcasses or from collection fees, they will have to discontinue offering dead stock cattle collection service. Raising collection fees in an attempt to shift a portion of the economic loss to the generators of these mortalities will only result in most cattle mortalities not coming to rendering. Consequently the efficiency of the USDA BSE surveillance initiative will be greatly diminished and regulatory control over these tissues will be lost. On the other hand, permitting renderers to remove SRMs from cattle mortalities would greatly mitigate lost revenue. NBP estimates the value of the remaining SRM-free materials and hides from cattle mortalities at $435 million ($521-$86 million). This amount would restore over 80% of the potential lost revenue associated with the prohibition of entire dead stock cattle carcasses and help sustain continued dead stock collection service, an efficient BSE surveillance, and regulatory control over the disposition of these tissues. 23. What other innovative solutions could be explored? No comment. 26. How can training and educational materials be designed or improved to meet the needs of multiple audiences with variable levels of scientific training? Assuming the Agency will try to achieve a uniform understanding among inspectors and those being inspected regarding SRM removal, NBP would recommend a video be created that demonstrates acceptable practices. 27. How can the Federal Government increase access to these materials? Making this type of material available on the Internet provides rapid and widespread dissemination. 28. Should FDA include exemptions to any new requirements to take into account the future development of new technologies or test methods that would establish that feed does not present a risk of BSE to ruminants? Yes. NBP is aware of research that is currently underway that could treat these materials in a way that makes them once again suitable for inclusion in animal feed. This endeavor involves the enzymatic hydrolysis of raw materials by a novel keratinase enzyme to degrade prions and eliminate potential infectivity. If successful this could prove to be the most practical and economic approach to handling these materials. Dr. Jason Shih at North Carolina State University, the discoverer of this novel enzyme, has so far demonstrated the degradation of the infectious prion protein so that it was undetectable by Western blot analysis (J. Animal Science, Vol. 82, Suppl. 1, p78, Abstract #2, 2004). Biological tests in transgenic mice are currently in progress to confirm the destruction of infectivity. Such a solution would render these materials free of potential infectivity and once again suitable for inclusion in all animal feed and pet food. While we acknowledge there would be some additional processing cost associated with this approach, restoring the feed value would most likely make it feasible for renderers to continue the collection and processing of cattle mortalities and SRMs. 29. If so, what process should FDA use to determine that the technologies or test methods are practical for use by the feed industry and ruminant feeders and provide scientifically valid and reliable results? Dr. Shih has also developed a surrogate protein that could serve as a marker when these materials are hydrolyzed and whose presence or absence could be confirmed by ELISA testing technology. The surrogate protein and ELISA test could be used not only to verify the effectiveness of the enzymatic treatment, but could also verify the efficiency of a clean-out procedure used for rendering systems. 30. Do FDA's existing authorities under the Federal Food, Drug, and Cosmetic Act (that address food adulteration and misbranding) and under the Public Health Service Act (that address the prevention and spread of communicable diseases) provide a legal basis to ban the use of SRMs and other cattle material in nonruminant animal feed (e.g., feed for horses, pigs, poultry, etc.) notwithstanding that such materials have not been shown to pose a direct risk to nonruminant animals? More specifically, under FDA's existing legal authorities, would the potential occurrence of on-farm feeding errors, of cross contamination of ruminant feed with SRMs and other cattle material, or of human exposure to nonruminant feed (including pet food) provide a basis to ban SRMs and other cattle material from all animal feed? No comment. 31. Are there other, related legal issues on which FDA should focus? We want to remind the Agency again that steps to further restrict the use of certain cattle proteins in animal feed should not be implemented without coordinating with APHIS the disposal of the raw materials from which they are generated. Unilateral steps by FDA to expand control over the use of finished rendered proteins will result in the unintended consequences of lost control over the disposal of these infectious tissues in their raw form and the elimination of access to these mortalities for BSE surveillance. National By-Products thanks the FDA for the opportunity to make comments as it examines measurers to further mitigate BSE risks. We can't emphasis enough the urgency facing APHIS regarding the safe disposal of any cattle tissues proposed to be removed from animal feed by the FDA. Absent regulations and economic conditions that make dead stock collection sustainable, NBP will discontinue this service. Please feel free to contact us if we can be of further assistance in crafting a workable approach to both further mitigating BSE risks while continuing to manage the conventional public and animal health risks associated with the disposal of these tissues and carcasses. Respectfully, Mark A. Myers David D Kirstein CEO & President Director of Technical Services