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From: TSS ()
December 20, 2005 Division of Dockets Management (HFA – 305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Docket No. 2002N – 0273 (Formerly Docket No. 02N-0273) RIN 0910 – AF46 Substances Prohibited From Use in Animal Food or Feed Comments by R-CALF USA Dear Administrator: The Ranchers-Cattlemen Action Legal Fund, United Stockgrowers of America (R-CALF USA) appreciates this opportunity to provide comments on the proposed rule by the Food and Drug Administration, Health and Human Services (FDA) to amend the regulations governing substances prohibited from use in animal food or feed (Proposed Rule). R-CALF USA is a non-profit association that represents over 18,000 U.S. cattle producers in 47 states and approximately 60 state and local affiliated cattleproducer associations. R-CALF USA’s membership consists primarily of cowcalf operators, cattle backgrounders, and feedlot owners. R-CALF USA’s concerns encompass trade and marketing issues that affect the health and welfare of the U.S. cattle herd, the economic welfare of U.S. cattle producers, the health and safety of U.S. beef consumers, and the sustainability of the environment. INTRODUCTION R-CALF USA previously submitted comments concerning the subject matter covered by this Proposed Rule on September 13, 2004. Specifically, RCALF USA’s comments were in response to the Animal and Plant Health Inspection Service (APHIS) Docket No. 04-047-1, Food Safety Inspection Service (FSIS) Docket No. 04-021 ANPR, and FDA Docket No. 2004N-0264 (RIN 0910 – AF46). R-CALF USA’s September 13, 2004 comments to the aforementioned agencies under the combined agency heading, “In the Matter of Federal Measures to Mitigate BSE Risks: Consideration for Further Action,” and are filed herewith and incorporated herein as Attachment A. 2 R-CALF USA appreciates the FDA’s efforts to eliminate the potential pathways of BSE infectivity by strengthening the U.S. feed ban. However, although a step in the right direction, the Proposed Rule to prohibit only brains and spinal cords from cattle over 30 months of age, the brains and spinal cords from cattle of any age not inspected and passed for human consumption, the entire carcass of cattle not inspected and passed for human consumption if the brains and spinal cords have not been removed, tallow that is derived from prohibited tissues that contain more than 0.15 percent insoluble impurities, and mechanically separated beef that is derived from the prohibited materials falls well short of addressing the increased risk of bovine spongiform encephalopathy (BSE) in several respects. A. The Proposed Rule Does Not Comply With Even The Minimal Standards Recommended By The World Organization for Animal Health (OIE) For Managing The Human And Health Risks Associated With The Presence Of BSE. 1. The Proposed Rule does not prohibit tonsils and distal ileums for use in feed as recommended by the OIE The 2005 recommendations of the OIE clearly state that tonsils and distal ileums should not be traded for the preparation of food, feed, or fertilizers if such tissues are derived from cattle of any age originating from a country defined as a “Controlled BSE risk.”1 The United States Department of Agriculture - Animal and Plant Health Inspection Service (APHIS) considers Canada a “Controlled BSE risk.”2 Because the United States allows the importation of cattle from Canada and does not propose to restrict the use of tonsils and distal ileums derived from these imported cattle in the production of animal feed, the Proposed Rule does not comport with OIE recommendations and will likely exacerbate problems associated with fully reopening U.S. beef export markets that have remained fully or partially closed since the discovery of a BSEinfected Canadian cow imported into the U.S. in 2003. Given that APHIS likewise considers the United States a “Controlled BSE risk,”3 the aforementioned problem will be further compounded unless FDA bans the use of tonsils and distal ileums from animal feed in its final rule. 2. The Proposed Rule does not prohibit eyes, skulls, or vertebral columns from all animals over 30 months of age for use in feed as recommended by the OIE The 2005 recommendations of the OIE clearly state that eyes, skulls and vertebral columns, in addition to brains and spinal cords, and any commodity contaminated by them, should not be traded for the preparation of food, feed, or fertilizer if such tissues are derived from cattle that were over 30 months of age originating from a country defined as a “Controlled BSE risk.”4 Inasmuch as the United States considers both the U.S. and Canada a “Controlled 1 Office International des Epizooties (OIE) 2005 Terrestrial Animal Health Code, Bovine Spongiform Encephalopathy, Chapter 2.3.13, at 2.3.13.13(1). See also Article 2.2.13.4. 2 See R-CALF USA v. USDA, CV-05060-BLG-RFC, Third Declaration of Lisa Ferguson, D.V.M., at ¶ 5, attached hereto as Attachment B. 3 Ibid. 4 Office International des Epizooties (OIE) 2005 Terrestrial Animal Health Code, Bovine Spongiform Encephalopathy, Chapter 2.3.13, at 2.3.13.13(2). See also Article 2.2.13.4. 3 BSE risk,” the failure of the United States to follow the international science-based recommendations of the OIE will further add to the United States’ ongoing difficulty of fully reopening U.S. beef export markets that have remained fully or partially closed since 2003. In addition, the Proposed Rule will subject the United States to the unnecessary and avoidable risks that the OIE’s recommendations are intended to address. Moreover, the USDA has recently restated its intention to resume imports of Canadian cattle over 30 months of age.5 This future action in combination with the Proposed Rule which does not comport with minimal OIE recommendations will obviously exacerbate the United States ongoing difficulty of fully restoring lost export markets and will further subject the U.S. to the unnecessary and avoidable risks that the OIE’s recommendations are designed to address. 3. The Proposed Rule does not prohibit eyes, skulls, and vertebral columns for use in feed from cattle over 12 months of age that originate in a country that does not meet the criteria of a “Controlled BSE risk” country as recommended by the OIE Notwithstanding APHIS’s assertion that Canada is a “Controlled BSE risk” country, Canada has not established that it is testing a sufficient number of cattle to comport with the OIE’s “Type A Surveillance” requirements.6 Based on the OIE’s Type A Surveillance recommendations found at Tables 1 and 2 of the OIE code, Canada would need to test 187,000 consecutive targeted cattle (with a BSE risk equal to that in the “Casualty slaughter, age between 4 and 7 years” subpopulation in Table 2), in order to comply with the OIE’s minimal recommendation for countries that (unlike Canada) have not identified any cases of BSE. However, Canada has only tested 54,481 cattle from January 1, 2005 through December 15, 2005, and it tested only 23,550 cattle in 2004.7 Because Canada has not established that it is testing sufficient numbers of cattle to maintain a “Controlled BSE risk” designation, Canada should be considered a country with an “Undetermined BSE risk.”8 As such, the OIE recommends that eyes, skulls and vertebral columns, in additions to brains and spinal cords, from cattle over 12 months of age not be traded for the preparation of food, feed, and fertilizer.9 Because Canada is testing an insufficient number of cattle to maintain a “Controlled BSE risk” designation, and because the United States is currently importing Canadian cattle under 30 months of age, the Proposed Rule would need to prohibit eyes, skulls and vertebral columns, in addition to brains and spinal cords, from Canadian cattle over 12 months of age in order to meet the minimal standards recommended by the OIE. Failure to meet the OIE’s minimal standards will further complicate the United States ability to fully reopen its lost export markets. 5 Federal Register, Vol. 70, No. 239, December 14, 2005, at 73915. 6 See Office International des Epizooties (OIE) 2005 Terrestrial Animal Health Code, Bovine Spongiform Encephalopathy, Chapter 2.3.13, at 2.3.13.4(2). 7 BSE Enhanced Surveillance Program, Canadian Food Inspection Agency, available at http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/surv/surve.shtml#num, downloaded on December 19, 2005. 8 See Office International des Epizooties (OIE) 2005 Terrestrial Animal Health Code, Bovine Spongiform Encephalopathy, Chapter 2.3.13, at 2.3.13.4(5). 9 See Id. at Article 2.3.13.13(3). 4 B. The Proposed Rule Fails To Close The Direct Pathways Of BSE Infectivity Left Open When USDA Resumed Importation of Canadian Cattle Unlike the United States, which has confirmed BSE only in a cow approximately 12 years of age, Canada has detected multiple cases of BSE in cattle averaging only 6 years and 10 months of age, with the youngest less than 6 years of age.10 This evidence suggests that the BSE agent has been amplifying in Canada for several generations, including the generation of cattle born after the implementation of Canada’s 1997 feed ban.11 Further evidence shows that the BSE agent has entered the Canadian feed supply as recently as 2003. 1. Canadian cattle were exposed to contaminated feed in 2003 A BSE infected cow was rendered into pet food and animal feed in Canada in 2003.12 The feed was distributed to 1800 farms but the Canadian government only surveyed 200 of these farms.13 The Canadian government found that ruminants may have been exposed on 1 percent of the 200 farms surveyed and it destroyed 63 cattle that may have eaten contaminated poultry feed on 3 of the surveyed farms.14 2. Only a fraction of potentially exposed cattle were destroyed Because the Canadian government found that exposure likely occurred in 3 out of 200 farms surveyed, exposure likely occurred on 27 farms total (3/200 = 27/1800). But, only 3 were mitigated. Therefore, it is likely that cattle on approximately 24 additional farms were exposed to contaminated feed in 2003, and no mitigation measures were reported to have been implemented on these farms. 3. Canadian cattle that were exposed to BSE infectivity and under 30 months of age are eligible for export to the United States. BSE infectivity has been confirmed in the distal ileum of cattle as early as 6 months postexposure and in the tonsils, where infectivity was confirmed at 10 months post-exposure.15 Thus, Canadian cattle born in 2003 and exposed to the contaminated feed may well be harboring BSE infectivity. The United States presently allows the importation of Canadian cattle under 30 months of age. 4. Tonsils and distal ileums from potentially infected Canadian cattle under 30 months of age may be lawfully rendered into poultry feed in the United States. 10 See R-CALF USA v. USDA, CV-05060-BLG-RFC, Statement of Facts in Support of Defendants’ Opposition to Plaintiff’s Motion for a Preliminary Injunction, at ¶ 41, Footnote 5, attached hereto as Attachment C. 11 Id. at ¶ 41. 12 Regulations Amending Certain Regulations Administered and Enforced by the Canadian Food Inspection Agency, Canadian Gazette, Vol. 138, No. 50, December 11, 2004, available at http://gazetteducanada.gc.ca/partI/2004/20041211/html/regle2-e.html, downloaded on December 20, 2005. 13 Ibid. 14 Ibid. 15 Federal Register, Vol. 70. No. 2, January 4, 2005, at 483. 5 The Proposed Rule does not prohibit the tonsils and distel ileums derived from Canadian cattle under 30 months of age that may be harboring BSE infectivity to be used in poultry feed in the United States. This presents a direct pathway of BSE infectivity into the United States poultry feed supply. 5. The Proposed Rule understates the lowest minimum infectious dose for BSE The Proposed Rule acknowledges that the minimum infectious dose for BSE may be lower than previously thought, citing a study in which infectivity was transmitted to an animal after ingesting only 0.01 gram of brain tissue from a BSE-infected animal.16 However, APHIS has cited a scientific study that indicates the infectious dose for BSE is many times lower than that reported in the Proposed Rule. APHIS claims that the lowest infectious dose for BSE is only 0.001 gram and BSE was orally transmitted to an animal after consuming this minute amount within a 68-month incubation period.17 This new scientific evidence belies the assumption within the Proposed Rule that the risk of spreading BSE to cattle via the consumption of spilled poultry feed contained in poultry litter poses “only a small baseline risk of BSE for ruminants.”18 The evidence instead shows that because the infectious dose is so minute, any direct pathway of BSE infectivity to cattle is significant and must be mitigated. 6. The Proposed Rule is inadequate because it does not prohibit the feeding of poultry litter containing spilled poultry feed infected with BSE to be lawfully fed directly to U.S. cattle. Given that the Canadian border was reopened in July 2005 to Canadian cattle that may have been exposed to BSE-infected feed, and because the infectious dose is much lower than the FDA originally believed, the Proposed Rule must be amended to block the direct pathways of BSE infectivity from Canada by prohibiting the practice of feeding poultry litter to cattle and prohibiting the use of tonsils and distal ileum from cattle of all ages in all animal feed. 7. The FDA’s assumption that reducing 90 percent of infectivity by the removal of only brains and spinal cords from animal feed does not adequately mitigate the remaining risk associated with a direct pathway of BSE infectivity from poultry feed to cattle. Until and unless the FDA conducts scientific studies to determine that the actual infectious dose for BSE from contaminated tissues, including but not limited to tonsils and distal ileums, entering poultry feed is significantly less than that associated with the consumption of brains and spinal cords, the FDA must not assume that poultry feed does not present a direct and unacceptable pathway of BSE infectivity for the U.S. cattle herd. 16 Federal Register, Vol. 70, No. 193, October 6, 2005, at 58577. 17 See R-CALF USA v. USDA, CV-05060-BLG-RFC, Declaration of William D. Hueston, Guy H. Loneragan, and Srinand Sreevatsan, at ¶ 10.4, Table 2, attached hereto as Attachment D. 18 Federal Register, Vol. 70, No. 193, October 6, 2005, at 58594. 6 C. The Proposed Rule Mistakenly Assumes, And Is Predicated On The Assumption, That The United States Has Implemented A Scientifically Valid Surveillance Program That the decision by FDA not to prohibit all tissues known to harbor BSE infectivity from all animal feed is dependent on the scientific validity of the current BSE surveillance program is evidenced by the FDA’s listing of U.S. surveillance results as one of four major factors underpinning the Proposed Rule.19 However, the current U.S. surveillance program has been audited by the USDA Office of Inspector General in 2004 and was found lacking in several critical areas that severely undermine the scientific validity, and therefore the utility, of the surveillance program for making decisions regarding additional measures needed to adequately protect U.S. cattle, and by extension, consumers, from BSE.20 1. The Office of Inspector General (OIG) raised concerns regarding the integrity of the surveillance data The Office of Inspector General (OIG) concluded that the U.S. surveillance program contained several limitations including that the surveillance program was not truly random because participation in the program was voluntary and that APHIS’s sampling plan assumes BSE is confined to the high-risk cattle population while other studies show that healthy-looking animals may also have BSE.21 The OIG also identified several challenges inherent to the operations of the surveillance program as it conducted prior to June 2004 and stated that such challenges still exist under the expanded program. These challenges include that cattle condemned at slaughter plants for CNS symptoms were not always tested for BSE.22 Most significantly, the OIG found that APHIS’s sampling and collection processes raise questions about the integrity of the surveillance data.23 2. The United States and Canada are the only BSE-affected countries in the world that have not implemented a mandatory testing program, even for high-risk animals The United States’ will continue to be challenged in its efforts to fully restore lost export markets so long as the U.S. refuses to adopt internationally practiced and accepted testing protocols for BSE.24 Further complicating this dilemma is that the U.S. continues to accept Canadian cattle and beef produced under the least stringent BSE risk mitigation measures recommended by the OIE, including a testing regime that does not comport to recommendations 19 Federal Register, Vol. 70, No. 193, October 6, 2005, at 58579. 20 See Audit Report, USDA Office of Inspector General, Great Plains Region, Report No. 50601-9-KC, August 2004, attached hereto as Attachment E. 21 Id. at i-ii. 22 Id. at ii. 23 Id. at 32. 24 John A. Fox, Hikaru Hanawa Peterson, Risks and Implications of Bovine Spongiform Encephalopathy for the United States: Insights from Other Countries, Kansas State University, at 53 (All casualty animals over 24 months tested for BSE in the European Union), at 54 (Japan BSE tests all slaughtered cattle for human consumption), attached hereto as Attachment F. 7 for “Controlled BSE risk” countries as stated above. No other BSE-affected countries are satisfied with these least stringent measures and have opted, instead, for the more stringent measures in order to ensure the eventual eradication of BSE.25 The FDA governs the most important control measure for preventing the amplification of BSE – an effective feed ban. Until and unless the USDA begins implementing BSE risk mitigation measures comparable to those implemented elsewhere in the world where BSE is known to exist, e.g., significantly increased testing particularly for high-risk cattle and full SRM removal at 12 months of age, the FDA must implement more stringent measures than are currently proposed in the Proposed Rule to ensure that BSE can not spread if introduced into or present in the U.S. feed system. D. The Proposed Rule Assumes The Existing Ruminant Feed Ban Has Provided Strong Protection Against BSE Despite Findings By The Government Accountability Office (GAO) That Compliance Was Uncertain Until Recently In a report released in 2002, the General Accountability Office (formally General Accounting Office) (GAO) stated that FDA did not take prompt enforcement action after the 1997 implementation of the existing U.S. feed ban to compel firms to comply with the feed ban.26 The report indicates that although the FDA reported hundreds of firms out of compliance prior to April 2001, FDA enforcement action was limited.27 The GAO found also that in light of the long incubation period for BSE (up to 8 years) the possibility that some contaminated animals or products have entered the United States cannot be ruled out.28 Based on these combined findings, the FDA should not assume that the feed ban has provided adequate protection against the recycling of BSE within the U.S. feed system during the early years of its implementation. Unfortunately, without significant improvements in USDA’s testing program as described above, there is insufficient scientific data to support a conclusion that only limited tissues known to harbor BSE infectivity need to be excluded from the animal feed supply. Even the more recent GAO report published in 2005 stated that program weaknesses continued to limit the effectiveness of the FDA feed ban.29 Moreover, the GAO found that claims regarding a high level of compliance with the feed ban cannot be supported. The GAO concluded in its study: Given these [program] weaknesses and the fact that FDA does not include all violations in its estimates, we believe FDA is overstating industry’s compliance with the animal feed ban and understating the potential risk of BSE for U.S. cattle in its reports to Congress and the American people. Despite the problems in FDA’s calculation, some in the feed industry claim that overall compliance with 25 See Appendix 1. 26 Mad Cow Disease, Improvements in the Animal Feed Ban and Other Regulatory Areas Would Strengthen U.S. Prevention Efforts, General Accounting Office, GAO-02-183, January 2002, at 23. 27 See Id. at 23-26. 28 Id. at 14. 29 Mad Cow Disease: FDA’s Management of the Feed Ban has Improved but Oversight Weaknesses Continue to Limit Program Effectiveness, GAO, GAO-05-101, February 2005. at 16. 8 the feed ban is nearly 100 percent—a claim that FDA’s compliance information does not support.30 The conclusion of the GAO belies the FDA’s assumption that the existing ruminant feed ban has provided adequate protection against BSE. When combined with the OIG’s strong critique against the validity of USDA’s current testing program discussed above, three of the four factors underpinning the FDA’s decision to allow tissues known to harbor BSE into the animal feed supply and to not require dedicated feed facilities are shown to be unjustified.31 Contrary to FDA’s fourth listed factor underpinning the Proposed Rule, i.e., that the Proposed Rule should be considered a “secondary level of protection,” the evidence shows that circumstances in the U.S. call for the implementation of the most robust and stringent feed ban rules that will ensure that any undetected or underlying BSE infectivity, spread during the period when mitigation measures were lacking, is completely arrested. The relaxation of such robust and comprehensive feed ban measure should not be considered until after a scientifically valid and internationally accepted surveillance program in the United States, and in countries that export beef and cattle to the United States, demonstrates that the BSE agent is no longer circulating in the animal feed chain. E. Even With The Proposed Rule The United States Will Continue To Have An Inferior Feed Ban When Compared To Countries That Have Proven Track Records For Reducing The Spread Of BSE The European experience provides the only empirical evidence of the effectiveness of various BSE risk mitigation measures. Europe first implemented a ruminant-to-ruminant feed ban comparable to the current U.S. feed ban in 1988.32 This early feed ban resulted in a 67 percent reduction of BSE cases in animals born in the first 12 months after the feed ban was implemented.33 However, these results were considered inadequate and Europe upgraded its feed ban in 1990 to exclude ruminant brain, spinal cord, thymus, tonsils, spleen, and intestines in all animal feed (including pet feed).34 This upgrade further reduced the hazard of the disease for cattle born in the first 12 months after its implementation by 46 percent.35 The Proposed Rule by FDA is less restrictive than this early European upgrade. But by 1994, Europe reported almost 10,000 BSE cases born after the 1988 feed ban, suggesting serious problems with cross- 30 Id. at 30. 31 See Federal Register, Vol. 70, No. 193, October 6, 2005, at 58579. 32 John A. Fox, Hikaru Hanawa Peterson, Risks and Implications of Bovine Spongiform Encephalopathy for the United States: Insights from Other Countries, Kansas State University, at 53, attached hereto as Attachment F; See also Prince, M.J., et. al., Bovine Spongiform Encephalopathy, Revue Scientifique et Technique, OIE, 22(1), 37-60, at 49. 33 Prince, M.J., et. al., Bovine Spongiform Encephalopathy, Revue Scientifique et Technique, OIE, 22(1), 37-60, at 49. 34 John A. Fox, Hikaru Hanawa Peterson, Risks and Implications of Bovine Spongiform Encephalopathy for the United States: Insights from Other Countries, Kansas State University, at 48, attached hereto as Attachment F; See also Prince, M.J., et. al., Bovine Spongiform Encephalopathy, Revue Scientifique et Technique, OIE, 22(1), 37-60, at 49; See also Brown, Paul, et. al., Bovine Spongiform Encephalopathy and Variant Creutzfeldt-Jakob Disease: Background, Evolution, and Current Concerns, Emerging Infectious Diseases 7(1): 6-16 (2001). 35 Prince, M.J., et. al., Bovine Spongiform Encephalopathy, Revue Scientifique et Technique, OIE, 22(1), 37-60, at 49. 9 contamination both in feed mills and on farms.36 In response to the continuing epidemic Europe upgraded its feed ban for the second time in 1994, expanding its feed ban to exclude all mammalian protein in ruminant feed.37 From 1990 to 2004 Europe experienced 12,000 cases of BSE in cattle born after the 1990 ban on SRMs in all animal feed.38 In response to this disappointing result, Europe upgraded its feed ban for a third time in 1996, prohibiting all mammalian meat-and-bone meal from all animal feed and fertilizer.39 And Europe upgraded its feed ban for the fourth time in 2001 by expanding the feed ban to include meat-and-bone meal and blood meal in feed for any farmed animal species.40 In Great Britain, where the epidemic was known to be severe, the number of BSE cases born during the year the 1st feed ban was implemented was 22,265.41 In 1990, the year of the 1st feed ban upgrade, 5,745 BSE cases were born.42 In 1994, the year of the 2nd upgrade, 2,150 new cases were born.43 In 1996, the year of the 3rd upgrade, only 65 new cases were born.44 In 2001, the year of the 4th upgrade, only 2 new BSE cases are known to have been born.45 As revealed by the foregoing discussion, new cases of BSE continued to occur after the implementation of the first European feed ban and after each of the four upgrades made over the course of 13 years. The United States can either learn from the European experience by adopting the most comprehensive measures arrived at by the application of the latest scientific evidence and trial and error, or the United States can risk repeating the European experiment by basing decisions on assumptions and wishful thinking, which could result in devastating consequences for the U.S. cattle industry. R-CALF USA urges the FDA to proceed with an abundance of caution by adopting a more comprehensive feed ban that is comparable to the feed ban now practiced in Europe. Such a feed ban should remain in effect until FDA has sufficient surveillance data to definitively determine whether the BSE case identified in the U.S. was indeed a rare occurrence and whether the BSE epidemic in Canada, or in any other BSE-affected country that imports cattle or beef into the United States, has subsided. 36 John A. Fox, Hikaru Hanawa Peterson, Risks and Implications of Bovine Spongiform Encephalopathy for the United States: Insights from Other Countries, Kansas State University, at 50, attached hereto as Attachment F. 37 John A. Fox, Hikaru Hanawa Peterson, Risks and Implications of Bovine Spongiform Encephalopathy for the United States: Insights from Other Countries, Kansas State University, at 50, attached hereto as Attachment F; see also Brown, Paul, et. al., Bovine Spongiform Encephalopathy and Variant Creutzfeldt-Jakob Disease: Background, Evolution, and Current Concerns, Emerging Infectious Diseases 7(1): 6-16 (2001). 38 John A. Fox, Hikaru Hanawa Peterson, Risks and Implications of Bovine Spongiform Encephalopathy for the United States: Insights from Other Countries, Kansas State University, at 50, attached hereto as Attachment F. 39 John A. Fox, Hikaru Hanawa Peterson, Risks and Implications of Bovine Spongiform Encephalopathy for the United States: Insights from Other Countries, Kansas State University, at 50, attached hereto as Attachment F; see also Brown, Paul, et. al., Bovine Spongiform Encephalopathy and Variant Creutzfeldt-Jakob Disease: Background, Evolution, and Current Concerns, Emerging Infectious Diseases 7(1): 6-16 (2001). 40 Ibid. 41 BSE: Statistics – Confirmed Cases of BSE Reported Worldwide, Year of Birth, DEFRA, available at http://www.defra.gov.uk/animalh/bse/statistics/bse/worldwide.htm, downloaded on December 19, 2005. 42 Ibid. 43 Ibid. 44 Ibid. 45 Ibid. 10 F. The Proposed Rule Ignores The Most Recent Scientific Research On BSE That Has Found Infectivity In Tissues Not Previously Known To Harbor The Disease The underlying assumption of the Proposed Rule is that FDA knows which tissues harbor BSE infectivity and at what levels. This assumption is no longer valid. Researchers in Germany have now found additional peripheral nervous system tissues, including the facial nerve and the sciatic nerve, which contain sufficient BSE infectivity to cause BSE infection.46 Before FDA decides to ban only the limited high-risk tissues from animal feed that it is presently proposing it should explain what additional mitigation measures are needed to reduce the risks that these new tissues present if they are allowed to enter the feed system where they may be inadvertently fed to cattle. It is important to note that the German study involved a cow naturally infected with BSE and various tissues of the infected cow were inoculated into transgenic mice. Thus, the outset of BSE infectivity in the subject mice demonstrated that the infectivity originated from the various tissues. In this study, the distal ileum, retina, optical nerve, facial nerve, and sciatic nerve, in addition to the brain stem and spinal cord, of the naturally infected cow all demonstrated infectivity.47 With this recent empirical evidence, it would not be prudent for FDA to allow the distal ileum into the animal food chain. According to a scientific abstract located on the website of the USDA-Food and Safety Inspection Service (FSIS), the recent finding of BSE infectivity in peripheral nerves by German researchers has been corroborated by researchers in Japan.48 The abstract points out that because detailed PrPSc distribution is obscure in BSE-infected cattle, the researchers set out to reassess the definitions of SRMs. Their findings included the detection of BSE in tissues previously known to harbor BSE and in previously unknown tissues including the sciatic nerve, tibial nerve, and vagus nerve.49 The FDA states that it does not have evidence that BSE is transmitted to cattle via blood or blood products.50 However, a recent scientific research paper published in August 2005 reveals how nascent the research surrounding BSE infectivity in blood has been by the announcement of the scientific advancement of biochemically detecting prions in blood for the first time.51 The researchers, from the U.S. (University of Texas) and Spain (Madrid) stated: We are currently studying the detection of prions in blood from infected animals during the presymptomatic phase as well as detection of PrPSc [prions] in plasma 46 See Anne Buschmann and Martin H. Gruschup, Highly Bovine Spongiform Encephalopathy–Sensitive Transgenic Mice Confirm the Essential Restriction of Infectivity to the Nervous System in Clinically Diseased Cattle, The Journal of Infectious Diseases, 192:934-42, September 1, 2005, Attached hereto as Attachment G. 47 Id. at 938. 48 See Abstract from the Priori Disease Research Center, National Institute of Animal Health, available at http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf, downloaded on December 20, 2005. 49 Ibid. 50 Federal Register, Vol. 70, No. 193, October 6, 2005, at 58596. 51 Joaquin Castilla et al., Detection of Prions in Blood, Nature Medicine, doi:10.1038/nm1286, August 28, 2005, Attached hereto as Attachment H. 11 and other blood fractions. The implementation of a similar blood-detection procedure for human and cattle samples will undoubtedly contribute to minimizing the risk of infection . . . and will have a tremendous impact on the beef industry. . .”52 Given the seriousness of this disease, i.e., it is incurable and always fatal, and based on this latest scientific discovery, the FDA should at least act with reasonable caution by instituting the reasonable safety measure of banning blood from cattle feed as is the current practice in both Europe53 and Japan.54 G. The Proposed Rule Continues to Ignore The Recommendations Of BSE Experts Regarding Appropriate Measures The United States Must Implement To Provide Adequate Protection Against The Potential Spread Of BSE 1. The Proposed Rule dismisses and ignores key recommendations made by Canada’s expert international team which included a BSE expert from the USDA. In response to its 2003 BSE case, Canada convened an “expert international team comprised of distinguished representatives from three continents.”55 Members of the team included Prof. Kihm, Switzerland, Prof. W. Hueston, USA, and Dr. D. Heim, Switzerland. This expert international team of scientists specifically recommended the following measures after Canada had detected only one indigenous case of BSE: a. “Measures to ensure that SRM are not included in human food and animal feed should be implemented, enforced and audited for compliance.” (Emphasis in original.)56 b. “The review team strongly endorses the exclusion of Specified Risk Materials from the feed chain as an effective means to reduce infectivity in meat and bone meal (MBM). The difficulty in distinguishing ruminant derived MBM from other mammalian and poultry derived MBM must be considered. Inclusion of any ruminant-derived MBM in ruminant feed rations should be avoided and opportunities for possible cross contamination eliminated. Whether this can be guaranteed by introduction of a mammalian MBM ban to ruminants or other specific measures has to be evaluated.”57 52 Joaquin Castilla et al., Detection of Prions in Blood, Nature Medicine, doi:10.1038/nm1286, August 28, 2005, at 3, Attached hereto as Attachment H. 53 Consolidated Text, Office for Official Publications of the European Communities, CONSLEG: 2001/R0999 – 01/07/2004, at 27, available at http://europa.eu.int/eur-lex/en/consleg/pdf/2001/en_2001R0999_do_001.pdf. 54 APHIS’ Consideration of Japan in Light of the World Organization for Animal Health’s (OIE) Guidelines, Veterinary Services, Animal and Plant Health Inspection Service, USDA, at 16. 55 Narrative Background to Canada’s Assessment of and Response to the BSE Occurrence in Alberta, Canadian Food Inspection Agency, July 2003, at 11, available at http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/evale.shtml, downloaded on December 20, 2005. 56 Report on Actions Taken by Canada in Response to the Confirmation of an Indigenous Case of BSE, Canadian Food Inspection Agency, at 5, available at http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/internate.shtml, downloaded on December 20, 2005. 57 Ibid. 12 Canada did not follow the scientific advice of its international review team. As a result, the BSE risk in Canada was not adequately or mitigated in a timely manner and the BSE agent may be continually recycling in Canada, through and among the deficiencies identified by the experts. Notwithstanding Canada’s inadequate response to these scientific recommendations, the U.S. has assumed the greater risk associated with Canada’s failure to implement needed measures by resuming imports of Canadian cattle and beef. This circumstance involving increased BSE risk from Canada necessitates a far more aggressive BSE defense than is proposed in the Proposed Rule. The United States has been dilatory in not responding in a timelier manner to the increased risks associated with Canada’s unwillingness to adopt needed measures. 2. The FDA did not timely respond to recommendations made by the United States Transmissible Spongiform Encephalopathy (TSE) Working Group and the Proposed Rule further ignores the recommendations made by this group of experts. In response to the May 2003 detection of a BSE-infected cow in Canada, the United State’s TSE Working Group was convened to make recommendations regarding appropriate measures to protect the U.S. against this new BSE threat. The TSE Working Group issued a report in June 2003 that recommended that significant trade in Canadian Commodities should not resume until “an assessment is completed to determine whether the BSE risk mitigation steps applied by Canada are sufficient. These should include: SRM removal from human and animal food [and] [d]edicated rendering facilities and mills for processing of ruminant byproducts.”58 In addition, the TSE Working Group made the following recommendations regarding specific measures needed to improve the feed bans in both the United States and in Canada: a. The TSE Working Group recommended that significant trade in Canadian commodities should not resume until “[a]dditional BSE risk mitigation steps are put in place in the US to address the handling of waste from edible product and from the byproducts from slaughter animals imported from Canadian [sic] including: • SRM removal from human and animal food • Dedicated rendering facilities and mills for processing of ruminant products • Elimination of the U.S. plate waste exemption by FDA or APHIS.”59 b. The TSE Working Group additionally recommended that FDA strengthen the U.S. feed ban to include: 1. “Dedicated facilities both for rendering and feed mills. Do not allow flushing as a means of separating ruminant and non-ruminant products, 2. remove plate waste and blood exemptions, 3. Prohibit poultry litter in ruminant feed.”60 58 Recommendations of APHIS TSE Working Group for allowing certain commodities from Canada to be imported into the United States, June 16, 2003, at 2, attached hereto as Attachment I. 59 Ibid. 13 c. The TSE Working Group also urged the FDA to take actions to prohibit the feeding of distressed pet food to cattle, “and require labeling to state that the product should not be fed to ruminants given that the highest risk segment of the cattle population (dead and down dairy cattle) is being used in pet food.”61 d. The TSE Working Group recommended that Canada be required to remove SRMs (defined as the brain, spinal cord, intestine, eyes, and tonsils from cattle of all ages) from human food.62 e. The TSE Working Group recommended that only beef from cattle slaughtered before reaching the age of 24 months, and which have had their brain, spinal cord, tonsil, eyes, and intestines removed, should be eligible for importation to the United States.63 f. Cognizant of the potential ramifications resulting from the resumption of trade with a country with BSE, the TSE Working Group recommended that USDA complete an assessment of trade impacts with the rest of the world before resuming trade with Canada.64 Neither the USDA nor the FDA heeded the aforementioned, specific advice of the BSE experts that comprise the TSE Working Group. As a result, for over two years the known risk of BSE has not been adequately mitigated either in Canada or in the United States. This failure to adequately mitigate the known BSE risk while simultaneously subjecting the U.S. to even greater risk by resuming imports of beef and cattle has contributed to the United State’s inability to fully restore lost export markets. The Japan government, for example, had submitted official comments to USDA calling for the segregation of U.S. beef and cattle from Canadian beef and cattle as well as calling upon the U.S. to not establish a “lower level of requirement” than that established in the OIE Code.65 Largely the result of its failure to heed this important advice from its own scientists, the USDA now finds itself in the unenviable position of trying to convince U.S. export countries that they should accept the BSE measures the USDA Final Rule imposed on Canada, which measures are far more lenient than the measures applied by every other BSE-affected country in the world. Because the FDA did not timely respond to the increased risk associated with Canada’s 2003 detection of BSE, the potential pathways of BSE infectivity that the TSE Working Group attempted to address have remained unabated, allowing for the potential amplification of BSE. It is, therefore, necessary to immediately strengthen the FDA feed ban to ensure completely that all 60 Recommendations of APHIS TSE Working Group for allowing certain commodities from Canada to be imported into the United States, June 16, 2003, at 2, attached hereto as Attachment I. 61 Ibid. 62 Id. at 7. 63 Id. at 8. 64 Id. at 2. 65 Comments of Government of Japan on Amendments by the Department of Agriculture of the United States Under Parts 93, 94, and 95 and notified in WTO Notification G/SPS/N/USA828, dated 11 November 3003 (Docket No. 03- 080-1), December 26, 2003. 14 tissues presently known or suspected to harbor BSE infectivity are excluded from the animal feed chain. 4. The Proposed Rule dismisses and ignores key scientific recommendations made by the United States’ International Review Team, which again included a USDA BSE expert, after a Canadian cow with BSE was detected in the United States Convened by the Secretary of Agriculture to review the response to the detection of a BSE case discovered in an imported Canadian cow in December 2003, the Foreign Animal and Poultry Disease Advisory Committee’s Subcommittee (International Review Team or IRT) was asked to review, among other things, the response actions taken by the United States to the BSE case detected in an imported Canadian cow, and to provide recommendations in the areas of SRM removal, slaughter methods, surveillance design and approaches, feed restrictions, feed manufacturing and sales, traceability enhancements, and other areas which could provide meaningful additional public or animal health benefits in light of the “North American” experience. The IRT team consisted of Prof. U.Kihm (Switzerland), Prof. W. Hueston (USA), Dr. D. Matthews (UK), Prof. S.C. MacDiarmid (New Zealand), and Dr. D. Heim (Switzerland).66 This esteemed collection of scientists, most with first-hand experience in managing the BSE epidemic in the U.K and Europe, recommended a number of key science-based risk mitigation measures that the Proposed Rule either ignores or only partially implements. These science-based measures include: a. The IRT urged USDA to give “strong consideration” to the removal of SRMs from both the human food and animal feed supplies.67 b. The IRT recommended that SRMs including brain, spinal cord, skull, vertebral column from cattle over 12 months of age and the intestine (from pylorus to anus) from cattle of all ages be removed “unless aggressive surveillance proves the BSE risk in the USA to be minimal according to OIE standards.” The IRT made its recommendation for a 12-month cut-off in “recognition of the fact that some cattle under 30 months of age may be slaughtered with infectivity present in the tissues described above [SRM tissues, including vertebral column].68 Even for Canada, where limited testing produced 4 cases of BSE within a two-year period, the USDA Final Rule uses a 30-month cut-off for the removal of all tissues except the tonsils and small intestines. This is over twice the age limit recommended by the IRT. Moreover, the 30-month cut-off reflects a dismissal of the scientific determination that infectivity may be present in cattle under 30 months of age. 66 Report on Measures Relating to Bovine Spongiform Encephalopathy (BSE) in the United States, February 2, 2004, at 1, attached hereto as Attachment J. 67 Id. at 5. 68 Ibid. 15 c. The IRT emphatically recommended that all SRM “must be excluded from all animal feed, including pet food.”69 d. The IRT stated the “partial (ruminant to ruminant) feed ban that is currently in place is insufficient to prevent exposure of cattle to the BSE agent” because it doesn’t address the dangers highlighted in Europe from accidental exposure by cattle to prohibited feed. The IRT stated it was “virtually impossible” to prevent cross contamination of unauthorized feed given the small dose of infected tissue required to infect cattle with BSE. Furthermore, the scientists cautioned, allowing protein from porcine or avian intestines, as both the U.S. and Canadian feed bans do, presents a risk from unauthorized protein that may remain in the digestive tracts of such animals and birds at slaughter.70 AR008029. Again, the USDA did not heed this scientific advice. e. The IRT signified the importance of strengthening the feed ban by separately reiterating its recommendation that the current feed ban be extended to exclude all mammalian and poultry protein from all ruminant feeds, “and that this ban as well as measures to prevent cross contamination be strongly enforced.”71 AR008030. CONCLUSION Neither the USDA nor the FDA have timely implemented the aforementioned recommendations made by leading U.S. and international scientists. As a result, the numerous pathways of BSE infectivity mentioned above have remained unabated. This has increased, rather than decreased the United States risk of BSE, particularly given that the U.S. has now resumed imports of cattle and cattle products from countries with an inherently greater risk for BSE. This has also exacerbated efforts to restore lost U.S. export markets. The solution is to immediately correct the known deficiencies of the United States’ BSE protection program. The FDA controls the single most important factor in preventing the spread and amplification of BSE – an effectively enforced feed ban. R-CALF USA urges the FDA to adopt far more comprehensive measures to strengthen the feed ban than those proposed in the Proposed Rule. R-CALF USA recommends the adoption of the measures listed above and recommended by U.S. and international scientists, along with the OIE. Specifically, R-CALF USA urges the adoption of the following measures: 1. Prohibit all SRMs in all animal feed with SRMs defined as brains, eyes, skull, spinal cord, trigeminal ganglia, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum) and dorsal root ganglia of all cattle over 12 months of age and the tonsils and entire intestine (from pylorus to anus) of cattle regardless of age. 69 Report on Measures Relating to Bovine Spongiform Encephalopathy (BSE) in the United States, February 2, 2004, at 8, attached hereto as Attachment J. 70 Id. at 8. 71 Id. at 9. 16 2. Prohibit all mammalian protein and mammalian byproducts in ruminant feed including poultry litter, plate waste, and blood. 3. Require facilities that manufacture ruminant feed to maintain dedicated facilities. As stated previously, these measures are now necessary because of the known deficiencies in the enforcement and effectiveness of the existing feed ban, the delay in implementation of any additional measures designed to address the spread of BSE after the risk became known in 2003, the acceptance of additional BSE risks associated with accepting cattle and beef products from a country where the scope of the risk is not scientifically known, and the need to comport with the OIE recommendations that are applied and practiced elsewhere in the world. These more stringent measures would need to remain in effect at least until the USDA improves its BSE surveillance program to a level that would allow for a scientifically valid and internationally accepted determination of the current status of the BSE epidemic in the United States and within any country that exports cattle and cattle products to the United States. Sincerely, Bill Bullard CEO ================================== ================================== Appendix I BSE Affected Countries Removal of at least brain, skull, vertebral column, etc. Testing High-risk Cattle (Downers, etc.) Testing at Normal Slaughter Meat and Bone Meal (MBM) Ban Ruminant Blood in Ruminant Feed EU > 12 months > 24 months > 30 months (> 24 for Germany) All animal feed No Japan All cattle All cattle All cattle All animal feed No Canada > 30 months Limited testing > 30 months None Ruminant feed only Allowed ==================== TSS
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