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From: TSS ()
The comments will be filed before the comment period closes Tuesday. In general, AFIA agrees that the proposed rule will reduce the already very small risk of BSE in the U.S. AFIA thinks the agency should not require the removal of brains and spinal cords from animals 30 months of age or younger that are dead or non-ambulatory, since FDA is not requiring such removal from animals that are slaughtered. Moreover, BSE is not found in animals under 30 months of age. AFIA recommended to FDA that renderers only should keep records of brain/spinal cord removal, that tests should be developed for brain/spinal cord presence and that the federal government must address the excess disposal of carcasses likely to result from the proposed rule. The affected industries should be part of the disposal discussions. FDA’s economic impact analysi is a matter of some dispute, and AFIA believes the agency should review additional analyses that are submitted for comment. Finally, AFIA applauded the agency and industries’ actions to maintain a near perfect rate of compliance and agreed to continue to support education, surveillance, compliance and enforcement actions regarding this rule. A copy of AFIA’s comments is available on the association’s web site at http://www.afia.org/img/assets/30/AFIA_BSE_comments12-15-05.pdf. http://www.world-grain.com/feature_stories.asp?ArticleID=77151 Division of Dockets Management VIA ELECTRONIC MAIL (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: Docket No. 2002N-0273, Proposed Rule Substances Prohibited From Use in Animal Food or Feed Dear Sir/Madam: The American Feed Industry Association (AFIA) is the national trade association representing feed and pet food manufacturers, ingredient manufacturers and suppliers, equipment manufacturers and other firms which supply goods and services to the feed industry. AFIA’s nearly 600 corporate members manufacture more than 75% of the nation’s primary feed. In addition, AFIA’s membership includes 21 state and eight national trade associations representing feed manufacturers and ingredient suppliers. Many AFIA members are subject to the current BSE feed regulation (21 CFR § 589.2000), and AFIA offers these comments on their behalf. AFIA believes there is no FDA regulation with a higher level of industry compliance than this BSE feed rule, and applauds the agency’s continuing industry education and compliance efforts. Continuing programs to promote education about, compliance with, surveillance for and enforcement of this rule are essential to insuring BSE does not establish and amplify in the U.S., as well as for maintaining high level of confidence in the U.S. beef supply by consumers and global trading partners. AFIA renews its commitment to support FDA’s efforts, and to seek adequate funding for continued education and compliance efforts at the state and federal levels. Only through this cooperative industry-government effort can we be effective in assuring the consuming public and our trading partners of the safety of the U.S. beef supply, while insuring continued animal health. AFIA Supports FDA’s Proposed Rulemaking; But Believes One Change is Needed AFIA generally supports the proposed changes to the BSE feed rule (21 CFR §589.2000) and creation of a new subsection 21 CFR § 589.2001. The approach proposed significantly reduces the already very low risk of BSE in the U.S. and is less costly than the approach proposed by FDA in January 2004. American Feed Industry Association Comments to FDA on Docket 2002N-0273 2 December 19, 2005 However, AFIA remains very concerned about the costs of carcass disposal from animals excluded from this proposed rule, as well as carcasses and materials that must be disposed of due to the consequences of this rule, i.e. significant changes in the rendering industry brought on by the proposed brain/spinal cord (B/SC) exclusions, including B/SC from all dead and nonambulatory animals regardless of age to be legal for rendering and feeding. AFIA agrees with FDA’s proposal to remove from the entire feed supply chain a limited list of certain tissues from cattle to prevent the inadvertent commingling of prohibited mammalian protein with ruminant feed. The rationale FDA puts forward for making this proposal is scientifically defensible -- with one exception. AFIA urges the agency to reduce the potential amount of unrenderable product that will likely result from the exclusion of SRMs and nonambulatory and dead animals for which B/SC is impractical or impossible. We believe the agency is being inconsistent in its application of risk reduction science by proposing to require the removal of B/SC in all dead or nonambulatory cattle, while allowing the feed use of B/SC from cattle less than 30 months of age for cattle which have been inspected and slaughtered. AFIA asserts the even-handed application of science dictates the retention of the B/SC in the feed chain from cattle less than 30 months of age provided the age of the animal can be verified. This approach is consistent with the generally accepted principle that cattle under 30 months of age have been rarely, if ever, diagnosed with BSE. This position, however, is dependent on a verifiable method of determining age. For dairy operations, we believe herd records would justify that requirement. Feedlot calves would also clearly meet this requirement. Amending this portion of the proposal will further reduce the expected amount of material to be disposed of with no expected risk elevation. The cost savings would be significant and is detailed in comments by the National Renderers Association. A Federal Government Task Force Should be Developed to Address Carcass Disposal AFIA’s primary concern, however, is the lack of a coordinated federal program -- or even guidance to industry for carcass and SRM disposal resulting from this proposal. FDA can reduce a significant amount of this material by amending the proposal to adopt AFIA’s suggestion allowing use in non-ruminant feed of B/SC from dead and nonambulatory cattle less than 30 months of age. At the same time, AFIA strongly urges the federal government to form a high-level state-federal task force to address the disposal issue. At the very least, this task force should include veterinary public health officials from each state. The task force should develop disposal options, and identify funding mechanisms to effect these options. The affected industries would be pleased to host roundtables, technical conferences or other meetings to address this issue. The failure of the federal government to address responsible and environmentally responsible disposal of the increased amount of cattle material and animals requiring options American Feed Industry Association Comments to FDA on Docket 2002N-0273 3 December 19, 2005 may lead to potential zoonootic disease transmission and further possibility of contamination of soil and water. AFIA believes FDA should promulgate a rule with the least amount of disposal issues and the maximum amount of risk reduction and the Federal Government agencies responsible for these issues should begin work when or if FDA finalizes this rule. Lack of a B/SC Test Method is a Concern, as Well as FDA’s Potential for Using PCR FDA raises the issue of a lack of analytical tests for detecting B/SC in rendered product. AFIA shares this concern, and believes if and when FDA finalizes this rule, it should fund analytical method development. Although recordkeeping is an important tool, the development of a definitive, sensitive test for cattle B/SC will greatly assist in compliance efforts. AFIA is aware the agency has developed an enhanced polymerase chain reaction (PCR) analytical test for bovine material in feed product. Of concern is the relative sensitivity of such a test that detects bovine protein that is airborne in or near feed milling operations. Before, FDA implements the regulatory testing of feed products, the agency needs to seriously consider the impact of airborne particles on the detection limits of this test method. AFIA does not support the use of such extremely sensitive methods that could result in positive findings for feed mills which do not handle prohibited mammalian protein in their manufacturing operations. Additional Recordkeeping Should be Required Only for Rendering Operations FDA asks for comments on extending recordkeeping requirements for this proposed regulation to industry segments beyond rendering operations. FDA explained the agency believes this would be redundant and therefore of little use. This proposed rule would require the removal of B/SC in certain cattle prior to rendering any tissue. The documentation (or testing, if developed) to insure this action has been taken must necessarily be done at the rendering operation. After the product is rendered, it would seem of little value to require records downstream from rendered product customers. Therefore, AFIA supports FDA’s position that recordkeeping at the rendering operation should be required to document the removal of B/SC from applicable cattle, and no other operations should be required to maintain additional, new records. FDA Should Compare Any Submitted, Relevant Comprehensive Economic Analysis Against FDA’s Published Ones To Insure the Full Magnitude is Addressed The economic impact of the proposed regulation on the rendering and animal production industries may be significant. AFIA believes the FDA should reevaluate the economic analysis of this rule prior to finalizing. Such an analysis should consider the overall economic impact of the proposed rule on all affected parties and be based on submitted, relevant data derived from a broad segment of the affected industries. Finally, AFIA cannot stress strongly enough that this and future notices and rulemaking should be directed to animal health, as USDA and FDA have removed as many human health American Feed Industry Association Comments to FDA on Docket 2002N-0273 4 December 19, 2005 concerns as are scientifically justified through previous actions banning the use of SRMs and downers in the food supply and related products. In summary, AFIA generally supports FDA’s proposed rule, but believes the proposal should be amended to allow in animal feed brains and spinal cords from dead and non-ambulatory cattle less than 30 month of age. FDA should pursue testing methodologies to detect B/SC in feed. The rendering industry should be required to keep additional records, and rendering industry customers should not have a duplicative recordkeeping burden. FDA and other federal agencies, in concert with state and industry interests, must address and develop practical and responsible alternatives and funding for disposal of additional carcasses and SRM material produced under this proposal. AFIA appreciates the opportunity to offer these comments. Sincerely, Richard Sellers Vice President, Feed Control & Nutrition American Feed Industry Association 1501 Wilson Blvd., Suite 1100 Arlington, VA 22209 703/524-0810 http://www.afia.org/img/assets/30/AFIA_BSE_comments12-15-05.pdf >>>AFIA thinks the agency should not require the removal of brains and spinal cords from animals 30 months of age or younger that are dead or non-ambulatory, since FDA is not requiring such removal from animals that are slaughtered. Moreover, BSE is not found in animals under 30 months of age.<<< the youngest age of BSE case to date is 20 months old; As at: 31 May http://www.defra.gov.uk/animalh/bse/bse-statistics/bse/yng-old.html http://www.defra.gov.uk/animalh/bse/index.html http://www.sare.org/htdocs/hypermail/html-home/28-html/0359.html snip... https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed Muscle tissue has recently been detected with PrPSc Yoshifumi Iwamaru, Yuka Okubo, Tamako Ikeda, Hiroko Hayashi, Mori- Priori Disease Research Center, National Institute of Animal Health, 3-1-5 Abstract Bovine spongiform encephalopathy (BSE) is a disease of cattle that causes The specified risk materials (SRM) are tissues potentially carrying BSE The 11th BSE case in Japan was detected in fallen stock surveillance. PrPSc was detected in brain, spinal cord, dorsal root ganglia, trigeminal Our results suggest that the currently accepted definitions of SRM in 179 T. Kitamoto (Ed.) The hardback book title is 'PRIONS' Food and Drug Safety We have to be careful that we don't get so set in the way we do things that Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't Dr. Keller: Tissues are routinely tested, based on which tissue provides an Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't The BSE enhanced surveillance program involves the use of a rapid screening test, followed by confirmatory testing for any samples that come back "inconclusive." The weekly summary below captures all rapid tests conducted as part of the enhanced surveillance effort. It should be noted that since the enhanced surveillance program began, USDA has also conducted approximately 9,200 routine IHC tests on samples that did not first undergo rapid testing. This was done to ensure that samples inappropriate for the rapid screen test were still tested, and also to monitor and improve upon IHC testing protocols. Of those 9,200 routine tests, one test returned a non-definitive result on July 27, 2005. That sample underwent additional testing at NVSL, as well as at the Veterinary Laboratories Agency in Weybridge, England, and results were negative. ... there is no increase in access to either the Japanese or South Korean markets, the result would be a net loss of $17.50 (the estimated cost of testing) per head. Alternatively, if full access to the Japanese and South Korean markets is regained without implementing a broad based BSE testing program, the potential revenue gain ranges from about $45 to $66 per head (Figure 1). nothing like 'sound science' in this administration, to hell with human health. Note: On Dec. 23, 2003, the U.S. Department of Agriculture reported that a cow in Washington state had tested positive for bovine spongiform encephalopathy (BSE, or mad cow disease). As a result, information on this Web page stating that no BSE cases had been found in the United States is now incorrect. However, because other information on this page continues to have value, the page will remain available for viewing. FDA ANNOUNCES TEST RESULTS FROM TEXAS FEED LOT FDA has determined that each animal could have consumed, at most and in total, five-and-one-half grams - approximately a quarter ounce -- of prohibited material. These animals weigh approximately 600 pounds. It is important to note that the prohibited material was domestic in origin (therefore not likely to contain infected material because there is no evidence of BSE in U.S. cattle), fed at a very low level, and fed only once. The potential risk of BSE to such cattle is therefore exceedingly low, even if the feed were contaminated. According to Dr. Bernard Schwetz, FDA's Acting Principal Deputy Commissioner, "The challenge to regulators and industry is to keep this disease out of the United States. One important defense is to prohibit the use of any ruminant animal materials in feed for other ruminant animals. Combined with other steps, like U.S. Department of Agriculture's (USDA) ban on the importation of live ruminant animals from affected countries, these steps represent a series of protections, to keep American cattle free of BSE." Despite this negligible risk, Purina Mills, Inc., is nonetheless announcing that it is voluntarily purchasing all 1,222 of the animals held in Texas and mistakenly fed the animal feed containing the prohibited material. Therefore, meat from those animals will not enter the human food supply. FDA believes any cattle that did not consume feed containing the prohibited material are unaffected by this incident, and should be handled in the beef supply clearance process as usual. FDA believes that Purina Mills has behaved responsibly by first reporting the human error that resulted in the misformulation of the animal feed supplement and then by working closely with State and Federal authorities. This episode indicates that the multi-layered safeguard system put into place is essential for protecting the food supply and that continued vigilance needs to be taken, by all concerned, to ensure these rules are followed routinely. FDA will continue working with USDA as well as State and local officials to ensure that companies and individuals comply with all laws and regulations designed to protect the U.S. food supply. Statement on Texas Cow With Central Nervous System Symptoms FDA, which is responsible for the safety of animal feed, immediately began an investigation. On Friday and throughout the weekend, FDA investigators inspected the slaughterhouse, the rendering facility, the farm where the animal came from, and the processor that initially received the cow from the slaughterhouse. FDA's investigation showed that the animal in question had already been rendered into "meat and bone meal" (a type of protein animal feed). Over the weekend FDA was able to track down all the implicated material. That material is being held by the firm, which is cooperating fully with FDA. Cattle with central nervous system symptoms are of particular interest because cattle with bovine spongiform encephalopathy or BSE, also known as "mad cow disease," can exhibit such symptoms. In this case, there is no way now to test for BSE. But even if the cow had BSE, FDA's animal feed rule would prohibit the feeding of its rendered protein to other ruminant animals (e.g., cows, goats, sheep, bison). FDA is sending a letter to the firm summarizing its findings and informing the firm that FDA will not object to use of this material in swine feed only. If it is not used in swine feed, this material will be destroyed. Pigs have been shown not to be susceptible to BSE. If the firm agrees to use the material for swine feed only, FDA will track the material all the way through the supply chain from the processor to the farm to ensure that the feed is properly monitored and used only as feed for pigs. To protect the U.S. against BSE, FDA works to keep certain mammalian protein out of animal feed for cattle and other ruminant animals. FDA established its animal feed rule in 1997 after the BSE epidemic in the U.K. showed that the disease spreads by feeding infected ruminant protein to cattle. Under the current regulation, the material from this Texas cow is not allowed in feed for cattle or other ruminant animals. FDA's action specifying that the material go only into swine feed means also that it will not be fed to poultry. FDA is committed to protecting the U.S. from BSE and collaborates closely with the U.S. Department of Agriculture on all BSE issues. The animal feed rule provides crucial protection against the spread of BSE, but it is only one of several such firewalls. FDA will soon be improving the animal feed rule, to make this strong system even stronger. #### Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog, Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe Deslys 100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg Primate (oral route)* 1/2 (50%) Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%) 1/15 (7%) RIII mice (icip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%) PrPres biochemical detection The comparison is made on the basis of calibration of the bovine inoculum used in our study with primates against a bovine brain inoculum with a similar PrPres concentration that was inoculated into mice and cattle.8 *Data are number of animals positive/number of animals surviving at the time of clinical onset of disease in the first positive animal (%). The accuracy of bioassays is generally judged to be about plus or minus 1 log. icip=intracerebral and intraperitoneal. Table 1: Comparison of transmission rates in primates and cattle infected orally with similar BSE brain inocula http://www.thelancet.com/journal/journal.isa It is clear that the designing scientists must also have shared Mr Bradley’s surprise at the results because all the dose levels right down to 1 gram triggered infection. 6. It also appears to me that Mr Bradley’s answer (that it would take less than say 100 grams) was probably given with the benefit of hindsight; particularly if one considers that later in the same answer Mr Bradley expresses his surprise that it could take as little of 1 gram of brain to cause BSE by the oral route within the same species. This information did not become available until the "attack rate" experiment had been completed in 1995/96. This was a titration experiment designed to ascertain the infective dose. A range of dosages was used to ensure that the actual result was within both a lower and an upper limit within the study and the designing scientists would not have expected all the dose levels to trigger infection. The dose ranges chosen by the most informed scientists at that time ranged from 1 gram to three times one hundred grams. It is clear that the designing scientists must have also shared Mr Bradley’s surprise at the results because all the dose levels right down to 1 gram triggered infection. [BBC radio 4 FARM news] http://www.maddeer.org/audio/BBC4farmingtoday2_1_03.ram http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm To cattle: 1 gram of infected brain material (by oral ingestion) http://www.inspection.gc.ca/english/sci/bio/bseesbe.shtml GAO October 11, 2005 http://www.gao.gov/cgi-bin/getrpt?GAO-06-157R Issued by: 03-025IFA From: Terry S. Singeltary Sr. [flounder9@verizon.net] Sent: Thursday, September 08, 2005 6:17 PM To: fsis.regulationscomments@fsis.usda.gov Subject: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Disabled Cattle Greetings FSIS, I would kindly like to submit the following to [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Disabled Cattle THE BSE/TSE SUB CLINICAL Non-Ambulatory Disabled Cattle Broken bones and such may be the first signs of a sub clinical BSE/TSE Non-Ambulatory Disabled Cattle ; snip...FULL TEXT ; AND WHOM HAVE THE FEEDERS PROTECTED IN THE PAST FROM MAD COW DISEASE AND WHAT WAS THERE MAJOR CONCERNS $ STRICTLY PRIVATE AND CONFIDENTIAL 25, AUGUST 1995 snip... To minimise the risk of farmers' claims for compensation from feed To minimise the potential damage to compound feed markets through adverse publicity. To maximise freedom of action for feed compounders, notably by snip... THE FUTURE 4.......... MAFF remains under pressure in Brussels and is not skilled at 5. Tests _may_ show that ruminant feeds have been sold which 6. The threat remains real and it will be some years before feed SEE full text ; http://www.bseinquiry.gov.uk/files/yb/1995/08/24002001.pdf THIS is what happens when you have the industry run the government. ... TSS
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