Docket No. 2004N-0264From: Bob Ehart [BobEhart@NASDA.ORG] Sent: Friday, August 13, 2004 4:30 PM To: fdadockets@oc.fda.gov Subject: Docket No. 2004N-0264 August 13, 2004 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20850 RE: Docket No. 2004N-0264/ RIN 0910-AF46 Comments submitted by the National Association of State Departments of Agriculture The National Association of State Departments of Agriculture (NASDA) is a nonprofit, nonpartisan association of public officials comprised of the Commissioners, Secretaries and Directors of the fifty states and four territories (Puerto Rico, Guam, American Samoa and the Virgin Islands). NASDA represents its members in the development, implementation and communication of sound public policy and programs, which support and promote the American agricultural industry, while protecting consumers and the environment. NASDA is providing comments on the advance notice of proposed rulemaking (ANPRM) regarding issues affecting FDA’s regulation of animal feed to reduce the potential for cattle to be infected with bovine spongiform encephalopathy (BSE)—Docket No. 2004N-0264/ RIN 0910-AF46—Federal Measures to Mitigate BSE Risks: Considerations for Further Action; Proposed Rule (regarding potential amendments to 21 CFR Part 589). NASDA appreciates the efforts made by the federal government, including FDA, to institute a firewall to protect against the entry of BSE into the country and, in those instances where it may enter, to limit the possibility that it may infect any other cattle. FDA’s feed ban, which went into effect in 1997, is an important part of the existing firewall. NASDA concurs that some additional actions should be taken to further strengthen the feed ban; however, we believe that FDA should conduct risk assessments to determine which actions are justified and best suited to provide an increased degree of protection of public and animal health. NASDA supports basing public policy on strong verifiable, scientific evidence wherever possible. There are instances where public policy may need to go beyond mere science; one of those areas is where the ability to enforce action(s) is/are complicated by merely basing the policy on what is known scientifically. More to the point, the NASDA Board passed a BSE policy in May 2004, requesting FDA to promulgate a rule to further strengthen the feed ban. Our concerns require that any option be scientifically sound, but also be assessed according to its enforceability, which may dictate policy beyond mere science. Specific language from the NASDA policy, which is pertinent to the FDA’s ANPRM, is as follows: Feed Policy: FDA. Immediately publish a rule dealing with issues under its jurisdiction to include, but not be limited to: Risk assessments on various options to expand the feed ban to assure that cattle do not become exposed to products that may contain trace amounts of prohibited products. For example, the risk assessments should address the benefits and consequences of: a.. Prohibiting the use of SRMs in all feed (ruminant and non-ruminant). b.. Prohibiting the use of ruminant protein in all ruminant feed. c.. Requiring renderers, feed manufacturing plants, transportation vehicles and storage areas to be dedicated so as to preclude the commingling of ruminant animal feed with any feed that contains any banned animal proteins. d.. Requiring all feed containing ruminant protein to bear the warning statement “Do Not Feed to Cattle or Other Ruminants.” NASDA also recognizes that some issues will become less significant if certain other actions are taken. For example, if SRMs are banned from all animal feed, the issue of dedicated facilities and equipment is of lesser concern. We support a policy that assures that inadvertent or accidental exposure to possible infected tissue is reduced by eliminating the potential for unknowingly exposing cattle to potentially infected tissue, while also assuring that purposeful violations are able to be swiftly adjudicated. An additional issue included as a part of the NASDA policy in May 2004, is a request that FDA, along with USDA and EPA, develop and implement effective methods for inactivation of transmissible spongiform encephalopathy (TSE) agents. This research is extremely important for finding methods to reduce the impacts from these debilitating diseases. The same is true for the need to identify alternative uses for the SRMs and other material that previously had economic uses. The following are specific comments on some of the questions posed by FDA in the ANPRM: 2. What data or scientific information is available to evaluate the IRT (International Review Team) 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? NASDA response to Q. 2 NASDA supports basing public policy on strong verifiable, scientific evidence wherever possible. There are instances where public policy may need to go beyond mere science, as is the case with this question. Removal of the small intestines is a defensible policy in order to assure removal of potentially infective material, a compromise between removal of the distal ileum and removal of the entire intestine, the latter of which does not seem warranted. The proposed policy to remove the small intestine seems justified on the basis that fewer mistakes will inadvertently, accidentally or purposefully be made, which could result in unacceptable levels of exposure. 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? NASDA response to Q. 3 Justification for further restrictions to reduce the potential of cross-contamination and/or feeding errors is based on developing an effective enforcement strategy. Since some scientific evidence indicates that very small amounts of infected prions fed to cattle are sufficient to cause BSE in susceptible animals, further reducing the potential for exposure may be justified. On-farm feeding errors can and likely will occur whenever different species of animals co-exist. For example, cattle are known to eat dog food when it is available. In addition, farmers seeking economical sources of protein can and do find alternative supplies, perhaps not always originally intended as cattle feed. 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? NASDA Response to Q. 4 Yes. 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? NASDA Response to Q. 6 Some system of permanent marking and/or lab analysis could be developed. SRM-free material could be labeled as containing no SRMs. Further processing of SRMs will likely require dedicated facilities and perhaps specific denaturing requirements to reduce the potential for these materials to be diverted to inappropriate uses. 7. What would be the economic and environmental impacts of prohibiting SRMs from use in all animal feed? NASDA Response to Q. 7 The impacts may be potentially quite significant and these concerns must be adequately addressed, as FDA determines which policy options to impose. These issues are not trivial and should not be taken lightly. If SRMs are prohibited from all animal feed, alternatives uses will need to be found or the tissue disposed of. The more tissue that is included in the SRMs, the greater the potential “disposal” problem the removal of the tissue becomes. On the one hand, adequate tissue should be removed to assure public and animal health objectives are met. On the other hand, until safe, cost-effective alternative uses are developed for the “waste tissue,” disposal costs could be prohibitively expensive, adversely affecting many segments of the industry. Conversely, if on-farm disposal becomes the usual method used to dispose of this tissue, in the long run, environmental risks could become a serious societal concern. 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? NASDA Response to Q. 9 When a facility making cattle or other ruminant feed does not handle prohibited material, the chance of commingling, contamination and accidental mixing or human errors is minimized. In the past, feed manufacturers and ruminant feeders have been encouraged to review, adopt and implement best management practices, such as those suggested by their trade associations which go above and beyond the current requirements and can further minimize the potential of BSE becoming established in the United States. If SRMs are banned from animal feed, less regulation of some facilities, storage and transportation might be warranted. 10. What would be the economic and environmental impacts of requiring dedicated facilities, equipment, storage, and transportation? NASDA Response to Q. 10 The impacts may be potentially quite significant and these concerns must be adequately addressed as FDA determines which policy options to impose. 11. What information, especially scientific data, is available to demonstrate that clean-out would provide adequate protection against cross contamination if SRMs are excluded from all animal feed? NASDA Response to Q. 11 Where dedicated facilities and equipment are not used, the FDA could mandate the validation of written clean-out procedures and record-keeping systems for all segments of the feed manufacturing industry including the distribution and transportation sectors. If scientific data is adequate to support establishing a safe level of BSE agent in ruminant feed, FDA could establish an authorized tolerance level. If the data is inadequate, FDA should not establish a tolerable level of contamination. 12. What information, especially scientific data, supports banning all mammalian and avian MBM in ruminant feed? NASDA Response to Q. 12 We are not aware of specific scientific data that indicates the banning of all mammalian and avian derived proteins will reduce the spread of BSE. However, a broader ban on animal protein products will reduce the reliance on inefficient analytical methods currently available to verify the sources of animal proteins in ruminant animal diets. 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? NASDA Response to Q. 13 While SRM contain the highest concentration of infectivity, there is scientific data that leads one to believe the misshapen prions may be present in other areas. Furthermore, there is no current analytical method to verify the source of proteins after they have been rendered, making surveillance and enforcement of a ban on prohibited animal proteins more difficult. 14. What would be the economic and environmental impacts of prohibiting all mammalian and avian MBM from ruminant feed? NASDA Response to Q. 14 The impacts may be potentially quite significant and these concerns must be adequately addressed as FDA determines which policy options to impose. 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? NASDA Response to Q. 15 According to the literature, misshapen prions can be identified in blood; however, no infectivity has been identified from blood or blood products. In addition, neither the Harvard Risk Assessment nor the International Review Team indicated blood or blood products to be an issue of concern. Further research on this issue is warranted. 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? NASDA response to Q. 17 If SRMs are removed from animal feed, poultry litter should not be a priority issue in reducing exposure to BSE. 18. What would be the economic and environmental impacts of prohibiting bovine blood or blood products, plate waste, or poultry litter from ruminant feed? NASDA Response to Q. 18 The impacts may be potentially quite significant and these concerns must be adequately addressed as FDA determines which policy options to impose. 20. Can SRMs be effectively removed from dead stock and non-ambulatory disabled cattle so that the remaining materials can be used in animal feed, or is it necessary to prohibit the entire carcass from dead stock and non-ambulatory disabled cattle from use in all animal feed? NASDA Response to Q. 20 It is imperative that any regulations developed to ban the inclusion of these materials be practical and enforceable and provide clear guidance to dead animal collectors and renderers as to the appropriate receipt, processing and disposition of these materials. Since there are no know method of analysis to recognize SRMs from other rendered animal protein, a ban could be considered, if these issues can not be adequately addressed. Identifying other economical uses for “waste” products is also imperative if the regulatory program is to adequately protect human and animal health. 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? NASDA Response to Q. 22 The impacts may be potentially quite significant and these concerns must be adequately addressed as FDA determines which policy options to impose. 26. How can training and educational materials be designed or improved to meet the needs of multiple audiences with variable levels of scientific training? NASDA Response to Q. 26 Training. The training materials produced are generally adequate, however, the timeliness and purpose of the material could sometimes be improved. Material, which is available at the time of program implementation, is effective in building public awareness and fostering a climate conducive to voluntary compliance. Seeking input from partners and some other stakeholders can also assure the material is useful to those using it and/or receiving it. Most issues can be properly described without the need for various documents; in some instances, a technical bulletin and a general education piece may be necessary. 27. How can the Federal Government increase access to these materials? NASDA Response to Q.27 If partners and stakeholders have been involved and the material is available when a “teachable moment” occurs, distribution will be adequate, although seldom if ever ideal. 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? NASDA Response to Q. 30 Yes. Yes. 34. Should FSIS provide an exemption for ``BSE free'' countries or countries with some other low-risk BSE designation (FDA asked for input on this question as well)? NASDA Response to Q. 34 The suggested actions here in the USA are based on “an abundance of caution.” If USA producers are going to be required to adhere to these new precautions, where only one imported cow has been identified as infected with BSE, importers should have to adhere to the same requirements. Sincerely, Gus R. Douglass Chair, Animal & Plant Industries Committee Commissioner, West Virginia Department of Agriculture Washington, DC Address: NASDA, Suite 1020 1156 15th St. NW Washington, DC 20005-1711 202-296-9680