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Docket No. FSIS-2006-0011E - Harvard Risk Assessment of BSE
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<blockquote data-quote="flounder" data-source="post: 271810" data-attributes="member: 3519"><p>----- Original Message ----- </p><p>From: "Terry S. Singeltary Sr." <flounder9@verizon.net></p><p>To: <fsis.regulationscomments@fsis.usda.gov></p><p>Sent: Tuesday, September 12, 2006 10:54 AM</p><p>Subject: Docket No. FSIS-2006-0011E - Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE) Update; Notice of Availability and Technical Meeting </p><p>Date: September 12, 2006 at 8:49 am PST</p><p></p><p></p><p>[Federal Register: September 12, 2006 (Volume 71, Number 176)]</p><p>[Notices]</p><p>[Page 53649-53650]</p><p>From the Federal Register Online via GPO Access [wais.access.gpo.gov]</p><p>[DOCID:fr12se06-33]</p><p></p><p>-----------------------------------------------------------------------</p><p></p><p>DEPARTMENT OF AGRICULTURE</p><p></p><p>Food Safety and Inspection Service</p><p></p><p>[Docket No. FSIS-2006-0011E]</p><p></p><p></p><p>Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE)</p><p>Update; Notice of Availability and Technical Meeting</p><p></p><p>AGENCY: Food Safety and Inspection Service, USDA.</p><p></p><p>ACTION: Notice of availability; reopening and extension of comment</p><p>period.</p><p></p><p>-----------------------------------------------------------------------</p><p></p><p>SUMMARY: The Food Safety and Inspection Service (FSIS) is reopening and</p><p>extending the comment period for the 2005 updated Harvard Risk</p><p>Assessment of bovine spongiform encephalopathy (BSE). The original</p><p>comment period closed on August 11, 2006. The Agency is taking this</p><p>action in response to a comment that was submitted after the Agency</p><p>held its July 25, 2006, technical meeting to provide information on the</p><p>updated risk assessment model and report.</p><p></p><p>DATES: Comments are due by October 27, 2006.</p><p></p><p></p><p>snip...</p><p></p><p><a href="http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/2006-0011E.htm" target="_blank">http://www.fsis.usda.gov/Frame/FrameRed ... -0011E.htm</a></p><p></p><p></p><p>Greetings FSIS,</p><p></p><p>I must comment please, on ;</p><p></p><p>Docket No. FSIS-2006-0011E - Harvard Risk Assessment of Bovine Spongiform</p><p>Encephalopathy (BSE) Update; Notice of Availability and Technical Meeting</p><p></p><p></p><p>I hope that you don't need more time to let industry reps try and water this</p><p>thing down as much as possible (just my opinion). HOWEVER, if you just look</p><p>at was was promised to us on SRMs before, and then the after product, only</p><p>then will you see just how industry friendly these regulations are. let's</p><p>first take a look at</p><p>what was first promised ;</p><p></p><p></p><p>FOR IMMEDIATE RELEASE</p><p>Monday, Jan. 26, 2004</p><p></p><p>FDA Press Office</p><p>301-827-6242</p><p>Expanded "Mad Cow" Safeguards Announced</p><p>to Strengthen Existing Firewalls Against BSE Transmission</p><p></p><p>HHS Secretary Tommy G. Thompson today announced several new public health</p><p>measures, to be implemented by the Food and Drug Administration (FDA), to</p><p>strengthen significantly the multiple existing firewalls that protect</p><p>Americans from exposure to the agent thought to cause bovine spongiform</p><p>encephalopathy (BSE, also known as mad cow disease) and that help prevent</p><p>the spread of BSE in U.S. cattle.</p><p></p><p>The existing multiple firewalls, developed by both the U.S. Department of</p><p>Agriculture (USDA) and HHS, have been extremely effective in protecting the</p><p>American consumer from exposure to BSE. The first firewall is based on</p><p>import controls started in 1989. A second firewall is surveillance of the</p><p>U.S. cattle population for the presence of BSE, a USDA firewall that led to</p><p>the finding of the BSE cow in December. The third firewall is FDA's 1997</p><p>animal feed ban, which is the critical safeguard to help prevent the spread</p><p>of BSE through cattle herds by prohibiting the feeding of most mammalian</p><p>protein to ruminant animals, including cattle. The fourth firewall, recently</p><p>announced by USDA, makes sure that no bovine tissues known to be at high</p><p>risk for carrying the agent of BSE enter the human food supply regulated by</p><p>USDA. The fifth firewall is effective response planning to contain the</p><p>potential for any damage from a BSE positive animal, if one is discovered.</p><p>This contingency response plan, which had been developed over the past</p><p>several years, was initiated immediately upon the discovery of a BSE</p><p>positive cow in Washington State December 23.</p><p></p><p>The new safeguards being announced today are science-based and further</p><p>bolster these already effective safeguards.</p><p></p><p>Specifically, HHS intends to ban from human food (including dietary</p><p>supplements), and cosmetics a wide range of bovine-derived material so that</p><p>the same safeguards that protect Americans from exposure to the agent of BSE</p><p>through meat products regulated by USDA also apply to food products that FDA</p><p>regulates.</p><p></p><p>FDA will also prohibit certain currently allowed feeding and manufacturing</p><p>practices involving feed for cattle and other ruminant animals. These</p><p>additional measures will further strengthen FDA's 1997 "animal feed" rule.</p><p></p><p>"Today's actions will make strong public health protections against BSE even</p><p>stronger," Secretary Thompson said. "Although the current animal feed rule</p><p>provides a strong barrier against the further spread of BSE, we must never</p><p>be satisfied with the status quo where the health and safety of our animals</p><p>and our population is at stake. The science and our own experience and</p><p>knowledge in this area are constantly evolving. Small as the risk may</p><p>already be, this is the time to make sure the public is protected to the</p><p>greatest extent possible."</p><p></p><p>"Today we are bolstering our BSE firewalls to protect the public," said FDA</p><p>Commissioner Mark B. McClellan, M.D., Ph.D. "We are further strengthening</p><p>our animal feed rule, and we are taking additional steps to further protect</p><p>the public from being exposed to any potentially risky materials from</p><p>cattle. FDA's vigorous inspection and enforcement program has helped us</p><p>achieve a compliance rate of more than 99 percent with the feed ban rule,</p><p>and we intend to increase our enforcement efforts to assure compliance with</p><p>our enhanced regulations. Finally, we are continuing to assist in the</p><p>development of new technologies that will help us in the future improve even</p><p>further these BSE protections. With today's actions, FDA will be doing more</p><p>than ever before to protect the public against BSE by eliminating additional</p><p>potential sources of BSE exposure."</p><p></p><p>To implement these new protections, FDA will publish two interim final rules</p><p>that will take effect immediately upon publication, although there will be</p><p>an opportunity for public comment after publication.</p><p></p><p>The first interim final rule will ban the following materials from</p><p>FDA-regulated human food, (including dietary supplements) and cosmetics:</p><p></p><p>* Any material from "downer" cattle. ("Downer" cattle are animals that</p><p>cannot walk.)</p><p>* Any material from "dead" cattle. ("Dead" cattle are cattle that die on the</p><p>farm (i.e. before reaching the slaughter plant);</p><p>* Specified Risk Materials (SRMs) that are known to harbor the highest</p><p>concentrations of the infectious agent for BSE, such as the brain, skull,</p><p>eyes, and spinal cord of cattle 30 months or older, and a portion of the</p><p>small intestine and tonsils from all cattle, regardless of their age or</p><p>health; and</p><p>* The product known as mechanically separated beef, a product which may</p><p>contain SRMs. Meat obtained by Advanced Meat Recovery (an automated system</p><p>for cutting meat from bones), may be used since USDA regulations do not</p><p>allow the presence of SRMs in this product.</p><p></p><p>The second interim final rule is designed to lower even further the risk</p><p>that cattle will be purposefully or inadvertently fed prohibited protein. It</p><p>was the feeding of such protein to cattle that was the route of disease</p><p>transmission that led to the BSE epidemic in United Kingdom cattle in the</p><p>1980's and 1990's.</p><p></p><p>This interim final rule will implement four specific changes in FDA's</p><p>present animal feed rule. First, the rule will eliminate the present</p><p>exemption in the feed rule that allows mammalian blood and blood products to</p><p>be fed to other ruminants as a protein source. Recent scientific evidence</p><p>suggests that blood can carry some infectivity for BSE.</p><p></p><p>Second, the rule will also ban the use of "poultry litter" as a feed</p><p>ingredient for ruminant animals. Poultry litter consists of bedding, spilled</p><p>feed, feathers, and fecal matter that are collected from living quarters</p><p>where poultry is raised. This material is then used in cattle feed in some</p><p>areas of the country where cattle and large poultry raising operations are</p><p>located near each other. Poultry feed may legally contain protein that is</p><p>prohibited in ruminant feed, such as bovine meat and bone meal. The concern</p><p>is that spillage of poultry feed in the chicken house occurs and that</p><p>poultry feed (which may contain protein prohibited in ruminant feed) is then</p><p>collected as part of the "poultry litter" and added to ruminant feed.</p><p></p><p>Third, the rule will ban the use of "plate waste" as a feed ingredient for</p><p>ruminants. Plate waste consists of uneaten meat and other meat scraps that</p><p>are currently collected from some large restaurant operations and rendered</p><p>into meat and bone meal for animal feed. The use of "plate waste" confounds</p><p>FDA's ability to analyze ruminant feeds for the presence of prohibited</p><p>proteins, compromising the Agency's ability to fully enforce the animal feed</p><p>rule.</p><p></p><p>Fourth, the rule will further minimize the possibility of</p><p>cross-contamination of ruminant and non-ruminant animal feed by requiring</p><p>equipment, facilities or production lines to be dedicated to non-ruminant</p><p>animal feeds if they use protein that is prohibited in ruminant feed.</p><p>Currently, some equipment, facilities and production lines process or handle</p><p>prohibited and non-prohibited materials and make both ruminant and</p><p>non-ruminant feed -- a practice which could lead to cross-contamination.</p><p></p><p>To accompany these new measures designed to provide a further layer of</p><p>protection against BSE, FDA will in 2004 step up its inspections of feed</p><p>mills and renderers. FDA will itself conduct 2,800 inspections and will make</p><p>its resources go even further by continuing to work with state agencies to</p><p>fund 3,100 contract inspections of feed mill and renderers and other firms</p><p>that handle animal feed and feed ingredients. Through partnerships with</p><p>states, FDA will also receive data on 700 additional inspections, for a</p><p>total of 3,800 state contract and partnership inspections in 2004 alone,</p><p>including annual inspections of 100 percent of all known renderers and feed</p><p>mills that process products containing materials prohibited in ruminant</p><p>feed.</p><p></p><p>"We have worked hard with the rendering and animal feed production</p><p>industries to try and achieve full compliance with the animal feed rule,"</p><p>said Dr. McClellan, "and through strong education and a vigorous enforcement</p><p>campaign, backed by additional inspections and resources, we intend to</p><p>maintain a high level of compliance."</p><p></p><p>Dr. McClellan also noted that, in response to finding a BSE positive cow in</p><p>Washington state December 23, FDA inspected and traced products at 22</p><p>facilities related to that positive cow or products from the cow, including</p><p>feed mills, farms, dairy farms, calf feeder lots, slaughter houses, meat</p><p>processors, transfer stations, and shipping terminals. Moreover, FDA has</p><p>conducted inspections at the rendering facilities that handled materials</p><p>from the positive cow, and they were found to be fully in compliance with</p><p>FDA's feed rule.</p><p></p><p>To further strengthen protections for Americans, FDA/HHS intends to work</p><p>with Congress to consider proposals to assure that these important</p><p>protective measures will be implemented as effectively as possible.</p><p></p><p>FDA is also continuing its efforts to assist in the development of better</p><p>BSE science, to achieve the same or greater confidence in BSE protection at</p><p>a lower cost. For example, to enhance the ability of our public health</p><p>system to detect prohibited materials in animal feed, FDA will continue to</p><p>support the development and evaluation of diagnostic tests to identify</p><p>prohibited materials. These tests would offer a quick and reliable method of</p><p>testing animal feeds for prohibited materials and for testing other products</p><p>for contamination with the agent thought to cause BSE.</p><p></p><p>FDA has publicly discussed many of the measures being announced today with</p><p>stakeholders in workshops, videoconferences, and public meetings. In</p><p>addition, FDA published an Advance Notice of Proposed Rulemaking in November</p><p>2002 (available online at <a href="http://www.fda.gov/OHRMS/DOCKETS/98fr/110602c.htm" target="_blank">http://www.fda.gov/OHRMS/DOCKETS/98fr/110602c.htm</a></p><p>concerning possible changes to the animal feed rule.</p><p></p><p>Comprehensive information about FDA's work on BSE and links to other related</p><p>websites are available at <a href="http://www.fda.gov" target="_blank">http://www.fda.gov</a>.</p><p></p><p>###</p><p></p><p><a href="http://www.fda.gov/bbs/topics/news/2004/hhs_012604.html" target="_blank">http://www.fda.gov/bbs/topics/news/2004/hhs_012604.html</a></p><p></p><p></p><p>YEP, were still waiting. WHILE were still waiting, the agent is still</p><p>amplifying and spreading through these...... how are they called ;</p><p></p><p>Expanded "Mad Cow" Safeguards Announced</p><p>to Strengthen Existing Firewalls Against BSE Transmission</p><p></p><p>or</p><p></p><p>The existing multiple firewalls, developed by both the U.S. Department of</p><p>Agriculture (USDA) and HHS, have been extremely effective in protecting the</p><p>American consumer from exposure to BSE.</p><p></p><p></p><p>LET US LOOK at these 'expanded, existing, firewalls, and just HOW MUCH</p><p>POTENTIAL MAD COW FEED they are speaking of IN COMMERCE IN 2006 ALONE. for</p><p>those that think i exploit these as.... how was it put to me recently on me</p><p>posting these recalls as only a 'potential hazard' and that the feed in</p><p>question was not obvious from 'BSE covert animals' and that would only be</p><p>true IF there were a BSE surveillance system in the USA that was set up to</p><p>FIND BSE cases. I think it has well been astablished that this is not the</p><p>case. IN fact Paul Brown said about the enfamous June 2004 Enhanced BSE</p><p>cover-up ;</p><p></p><p>CDC DR. PAUL BROWN TSE EXPERT COMMENTS 2006</p><p></p><p>The U.S. Department of Agriculture was quick to assure the public earlier</p><p>this week that the third case of mad cow disease did not pose a risk to</p><p>them, but what federal officials have not acknowledged is that this latest</p><p>case indicates the deadly disease has been circulating in U.S. herds for at</p><p>least a decade.</p><p></p><p>The second case, which was detected last year in a Texas cow and which USDA</p><p>officials were reluctant to verify, was approximately 12 years old.</p><p></p><p>These two cases (the latest was detected in an Alabama cow) present a</p><p>picture of the disease having been here for 10 years or so, since it is</p><p>thought that cows usually contract the disease from contaminated feed they</p><p>consume as calves. The concern is that humans can contract a fatal,</p><p>incurable, brain-wasting illness from consuming beef products contaminated</p><p>with the mad cow pathogen.</p><p></p><p>"The fact the Texas cow showed up fairly clearly implied the existence of</p><p>other undetected cases," Dr. Paul Brown, former medical director of the</p><p>National Institutes of Health's Laboratory for Central Nervous System</p><p>Studies and an expert on mad cow-like diseases, told United Press</p><p>International. "The question was, 'How many?' and we still can't answer</p><p>that."</p><p></p><p>Brown, who is preparing a scientific paper based on the latest two mad cow</p><p>cases to estimate the maximum number of infected cows that occurred in the</p><p>United States, said he has "absolutely no confidence in USDA tests before</p><p>one year ago" because of the agency's reluctance to retest the Texas cow</p><p>that initially tested positive.</p><p></p><p>USDA officials finally retested the cow and confirmed it was infected seven</p><p>months later, but only at the insistence of the agency's inspector general.</p><p></p><p>"Everything they did on the Texas cow makes everything USDA did before 2005</p><p>suspect," Brown said. ...snip...end</p><p></p><p></p><p><a href="http://www.upi.com/ConsumerHealthDaily/view.php?StoryID=20060315-055557-1284r" target="_blank">http://www.upi.com/ConsumerHealthDaily/ ... 5557-1284r</a></p><p></p><p></p><p>AND NOT TO FORGET what the OIG has said time and time again over the years;</p><p></p><p></p><p><a href="http://www.usda.gov/oig/webdocs/50601-10-KC.pdf" target="_blank">http://www.usda.gov/oig/webdocs/50601-10-KC.pdf</a></p><p></p><p></p><p>03-025IF 03-025IF-631 Linda A. Detwiler [PDF]</p><p></p><p><a href="http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-631.pdf" target="_blank">http://www.fsis.usda.gov/OPPDE/Comments ... IF-631.pdf</a></p><p></p><p>Specified Risk Materials (SRMs)</p><p></p><p>I am in full support of the interim final rule which prohibits SRMs from</p><p></p><p>being included in food for human consumption. In addition to the list of</p><p></p><p>tissues published in this rule, I am requesting that additional tissues be</p><p></p><p>added to the list. These would include dura</p><p></p><p>("sheath") covering the spinal cord and the ENTIRE INTESTINE (from pylorus</p><p></p><p>to rectum). The scientific justification is provided below. THESE SRMs</p><p></p><p>should also be prohibited from ANY FDA regulated food or product intended</p><p></p><p>for human consumption, including but not limited to flavorings, extracts,</p><p></p><p>etc. ...</p><p></p><p>Dr. Linda Detwiler comments in full;</p><p></p><p><a href="http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-634.pdf" target="_blank">http://www.fsis.usda.gov/OPPDE/Comments ... IF-634.pdf</a></p><p></p><p></p><p>[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk</p><p>Materials for Human Food and Requirement for the Disposition of</p><p>Non-Ambulatory Disabled Cattle</p><p></p><p><a href="http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000534-01-vol45.pdf" target="_blank">http://www.fda.gov/ohrms/dockets/docket ... -vol45.pdf</a></p><p></p><p><a href="http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf" target="_blank">http://www.fda.gov/ohrms/dockets/docket ... -vol40.pdf</a></p><p></p><p>THE SEVEN 1/2 SCIENTIST REPORT *** ;-)</p><p></p><p><a href="http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf" target="_blank">http://www.fda.gov/ohrms/dockets/docket ... tach-1.pdf</a></p><p></p><p><a href="https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument" target="_blank">https://web01.aphis.usda.gov/regpublic. ... enDocument</a></p><p></p><p><a href="http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdf" target="_blank">http://www.fda.gov/ohrms/dockets/docket ... -vol35.pdf</a></p><p></p><p>SO, let me exploit these FACTS again. I mean these feeders are still</p><p>laughing all the way to the bank, while spreading the mad cow agent to hell</p><p>and back in the USA ;</p><p></p><p></p><p>Subject: MAD COW FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL,</p><p>TN, AND WV</p><p>Date: September 6, 2006 at 7:58 am PST</p><p></p><p>PRODUCT</p><p>a) EVSRC Custom dairy feed, Recall # V-130-6;</p><p>b) Performance Chick Starter, Recall # V-131-6;</p><p>c) Performance Quail Grower, Recall # V-132-6;</p><p>d) Performance Pheasant Finisher, Recall # V-133-6.</p><p>CODE</p><p>None</p><p>RECALLING FIRM/MANUFACTURER</p><p>Donaldson & Hasenbein/dba J&R Feed Service, Inc., Cullman, AL, by telephone</p><p>on June 23, 2006 and by letter dated July 19, 2006. Firm initiated recall is</p><p>complete.</p><p>REASON</p><p>Dairy and poultry feeds were possibly contaminated with ruminant based</p><p>protein.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>477.72 tons</p><p>DISTRIBUTION</p><p>AL</p><p>______________________________</p><p>PRODUCT</p><p>a) Dairy feed, custom, Recall # V-134-6;</p><p>b) Custom Dairy Feed with Monensin, Recall # V-135-6.</p><p>CODE</p><p>None. Bulk product</p><p>RECALLING FIRM/MANUFACTURER</p><p>Recalling Firm: Burkmann Feed, Greeneville, TN, by Telephone beginning on</p><p>June 28, 2006.</p><p>Manufacturer: H. J. Baker & Bro., Inc., Albertville, AL. Firm initiated</p><p>recall is complete.</p><p>REASON</p><p>Possible contamination of dairy feeds with ruminant derived meat and bone</p><p>meal.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>1,484 tons</p><p>DISTRIBUTION</p><p>TN and WV</p><p></p><p></p><p><a href="http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00968.html</a></p><p></p><p>Subject: MAD COW FEED RECALLS ENFORCEMENT REPORT FOR AUGUST 9, 2006 KY, LA,</p><p>MS, AL, GA, AND TN 11,000+ TONS</p><p>Date: August 16, 2006 at 9:19 am PST</p><p></p><p>RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II</p><p>______________________________</p><p>PRODUCT</p><p>Bulk custom made dairy feed, Recall # V-115-6</p><p>CODE</p><p>None</p><p>RECALLING FIRM/MANUFACTURER</p><p>Hiseville Feed & Seed Co., Hiseville, KY, by telephone and letter on or</p><p>about July 14, 2006. FDA initiated recall is ongoing.</p><p>REASON</p><p>Custom made feeds contain ingredient called Pro-Lak which may contain</p><p>ruminant derived meat and bone meal.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>Approximately 2,223 tons</p><p>DISTRIBUTION</p><p>KY</p><p></p><p>______________________________</p><p>PRODUCT</p><p>Bulk custom made dairy feed, Recall # V-116-6</p><p>CODE</p><p>None</p><p>RECALLING FIRM/MANUFACTURER</p><p>Rips Farm Center, Tollesboro, KY, by telephone and letter on July 14, 2006.</p><p>FDA initiated recall is ongoing.</p><p>REASON</p><p>Custom made feeds contain ingredient called Pro-Lak which may contain</p><p>ruminant derived meat and bone meal.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>1,220 tons</p><p>DISTRIBUTION</p><p>KY</p><p></p><p>______________________________</p><p>PRODUCT</p><p>Bulk custom made dairy feed, Recall # V-117-6</p><p>CODE</p><p>None</p><p>RECALLING FIRM/MANUFACTURER</p><p>Kentwood Co-op, Kentwood, LA, by telephone on June 27, 2006. FDA initiated</p><p>recall is completed.</p><p>REASON</p><p>Possible contamination of animal feed ingredients, including ingredients</p><p>that are used in feed for dairy animals, with ruminant derived meat and bone</p><p>meal.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>40 tons</p><p>DISTRIBUTION</p><p>LA and MS</p><p></p><p>______________________________</p><p>PRODUCT</p><p>Bulk Dairy Feed, Recall V-118-6</p><p>CODE</p><p>None</p><p>RECALLING FIRM/MANUFACTURER</p><p>Cal Maine Foods, Inc., Edwards, MS, by telephone on June 26, 2006. FDA</p><p>initiated recall is complete.</p><p>REASON</p><p>Possible contamination of animal feed ingredients, including ingredients</p><p>that are used in feed for dairy animals, with ruminant derived meat and bone</p><p>meal.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>7,150 tons</p><p>DISTRIBUTION</p><p>MS</p><p></p><p>______________________________</p><p>PRODUCT</p><p>Bulk custom dairy pre-mixes, Recall # V-119-6</p><p>CODE</p><p>None</p><p>RECALLING FIRM/MANUFACTURER</p><p>Walthall County Co-op, Tylertown, MS, by telephone on June 26, 2006. Firm</p><p>initiated recall is complete.</p><p>REASON</p><p>Possible contamination of dairy animal feeds with ruminant derived meat and</p><p>bone meal.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>87 tons</p><p>DISTRIBUTION</p><p>MS</p><p></p><p>______________________________</p><p>PRODUCT</p><p>Bulk custom dairy pre-mixes, Recall # V-120-6</p><p>CODE</p><p>None</p><p>RECALLING FIRM/MANUFACTURER</p><p>Ware Milling Inc., Houston, MS, by telephone on June 23, 2006. Firm</p><p>initiated recall is complete.</p><p>REASON</p><p>Possible contamination of dairy animal feeds with ruminant derived meat and</p><p>bone meal.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>350 tons</p><p>DISTRIBUTION</p><p>AL and MS</p><p></p><p>______________________________</p><p>PRODUCT</p><p>a) Tucker Milling, LLC Tm 32% Sinking Fish Grower, #2680-Pellet,</p><p>50 lb. bags, Recall # V-121-6;</p><p>b) Tucker Milling, LLC #31120, Game Bird Breeder Pellet,</p><p>50 lb. bags, Recall # V-122-6;</p><p>c) Tucker Milling, LLC #31232 Game Bird Grower,</p><p>50 lb. bags, Recall # V-123-6;</p><p>d) Tucker Milling, LLC 31227-Crumble, Game Bird Starter, BMD</p><p>Medicated, 50 lb bags, Recall # V-124-6;</p><p>e) Tucker Milling, LLC #31120, Game Bird Breeder, 50 lb bags,</p><p>Recall # V-125-6;</p><p>f) Tucker Milling, LLC #30230, 30 % Turkey Starter, 50 lb bags,</p><p>Recall # V-126-6;</p><p>g) Tucker Milling, LLC #30116, TM Broiler Finisher,</p><p>50 lb bags, Recall # V-127-6</p><p>CODE</p><p>All products manufactured from 02/01/2005 until 06/20/2006</p><p>RECALLING FIRM/MANUFACTURER</p><p>Recalling Firm: Tucker Milling LLC, Guntersville, AL, by telephone and visit</p><p>on June 20, 2006, and by letter on June 23, 2006.</p><p>Manufacturer: H. J. Baker and Brothers Inc., Stamford, CT. Firm initiated</p><p>recall is ongoing.</p><p>REASON</p><p>Poultry and fish feeds which were possibly contaminated with ruminant based</p><p>protein were not labeled as "Do not feed to ruminants".</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>7,541-50 lb bags</p><p>DISTRIBUTION</p><p>AL, GA, MS, and TN</p><p></p><p>END OF ENFORCEMENT REPORT FOR AUGUST 9, 2006</p><p></p><p>###</p><p></p><p></p><p><a href="http://www.fda.gov/bbs/topics/ENFORCE/2006/ENF00964.html" target="_blank">http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00964.html</a></p><p></p><p></p><p>Subject: MAD COW FEED RECALL MI MAMMALIAN PROTEIN VOLUME OF PRODUCT IN</p><p>COMMERCE 27,694,240 lbs</p><p>Date: August 6, 2006 at 6:14 pm PST</p><p>PRODUCT</p><p>Bulk custom dairy feds manufactured from concentrates, Recall # V-113-6</p><p>CODE</p><p>All dairy feeds produced between 2/1/05 and 6/16/06 and containing H. J.</p><p>Baker recalled feed products.</p><p>RECALLING FIRM/MANUFACTURER</p><p>Vita Plus Corp., Gagetown, MI, by visit beginning on June 21, 2006. Firm</p><p>initiated recall is complete.</p><p>REASON</p><p>The feed was manufactured from materials that may have been contaminated</p><p>with mammalian protein.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>27,694,240 lbs</p><p>DISTRIBUTION</p><p>MI</p><p></p><p></p><p>END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006</p><p></p><p>###</p><p></p><p></p><p><a href="http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00963.html</a></p><p></p><p></p><p>Subject: MAD COW FEED RECALL AL AND FL VOLUME OF PRODUCT IN COMMERCE 125</p><p>TONS Products manufactured from 02/01/2005 until 06/06/2006</p><p>Date: August 6, 2006 at 6:16 pm PST</p><p>PRODUCT</p><p>a) CO-OP 32% Sinking Catfish, Recall # V-100-6;</p><p>b) Performance Sheep Pell W/Decox/A/N, medicated,</p><p>net wt. 50 lbs, Recall # V-101-6;</p><p>c) Pro 40% Swine Conc Meal -- 50 lb, Recall # V-102-6;</p><p>d) CO-OP 32% Sinking Catfish Food Medicated,</p><p>Recall # V-103-6;</p><p>e) "Big Jim's" BBB Deer Ration, Big Buck Blend,</p><p>Recall # V-104-6;</p><p>f) CO-OP 40% Hog Supplement Medicated Pelleted,</p><p>Tylosin 100 grams/ton, 50 lb. bag, Recall # V-105-6;</p><p>g) Pig Starter Pell II, 18% W/MCDX Medicated 282020,</p><p>Carbadox -- 0.0055%, Recall # V-106-6;</p><p>h) CO-OP STARTER-GROWER CRUMBLES, Complete</p><p>Feed for Chickens from Hatch to 20 Weeks, Medicated,</p><p>Bacitracin Methylene Disalicylate, 25 and 50 Lbs,</p><p>Recall # V-107-6;</p><p>i) CO-OP LAYING PELLETS, Complete Feed for Laying</p><p>Chickens, Recall # 108-6;</p><p>j) CO-OP LAYING CRUMBLES, Recall # V-109-6;</p><p>k) CO-OP QUAIL FLIGHT CONDITIONER MEDICATED,</p><p>net wt 50 Lbs, Recall # V-110-6;</p><p>l) CO-OP QUAIL STARTER MEDICATED, Net Wt. 50 Lbs,</p><p>Recall # V-111-6;</p><p>m) CO-OP QUAIL GROWER MEDICATED, 50 Lbs,</p><p>Recall # V-112-6</p><p>CODE</p><p>Product manufactured from 02/01/2005 until 06/06/2006</p><p>RECALLING FIRM/MANUFACTURER</p><p>Alabama Farmers Cooperative, Inc., Decatur, AL, by telephone, fax, email and</p><p>visit on June 9, 2006. FDA initiated recall is complete.</p><p>REASON</p><p>Animal and fish feeds which were possibly contaminated with ruminant based</p><p>protein not labeled as "Do not feed to ruminants".</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>125 tons</p><p>DISTRIBUTION</p><p>AL and FL</p><p></p><p></p><p>END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006</p><p></p><p>###</p><p></p><p></p><p><a href="http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00963.html</a></p><p></p><p></p><p>Subject: MAD COW FEED RECALL KY VOLUME OF PRODUCT IN COMMERCE ?????</p><p>Date: August 6, 2006 at 6:19 pm PST</p><p>PRODUCT</p><p>Bulk custom made dairy feed, Recall # V-114-6</p><p>CODE</p><p>None</p><p>RECALLING FIRM/MANUFACTURER</p><p>Burkmann Feeds LLC, Glasgow, KY, by letter on July 14, 2006. Firm initiated</p><p>recall is ongoing.</p><p>REASON</p><p>Custom made feeds contain ingredient called Pro-Lak, which may contain</p><p>ruminant derived meat and bone meal.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>?????</p><p>DISTRIBUTION</p><p>KY</p><p>END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006</p><p></p><p>###</p><p></p><p></p><p><a href="http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00963.html</a></p><p></p><p></p><p>CJD WATCH MESSAGE BOARD</p><p>TSS</p><p>MAD COW FEED RECALL USA EQUALS 10,878.06 TONS NATIONWIDE</p><p>Sun Jul 16, 2006 09:22</p><p>71.248.128.67</p><p></p><p></p><p>RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II</p><p>______________________________</p><p>PRODUCT</p><p>a) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals,</p><p>Recall # V-079-6;</p><p>b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg),</p><p>Recall # V-080-6;</p><p>c) PRO-PAK, MARINE & ANIMAL PROTEIN CONCENTRATE FOR USE IN ANIMAL</p><p>FEED, Recall # V-081-6;</p><p>d) Feather Meal, Recall # V-082-6</p><p>CODE</p><p>a) Bulk</p><p>b) None</p><p>c) Bulk</p><p>d) Bulk</p><p>RECALLING FIRM/MANUFACTURER</p><p>H. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 and</p><p>by press release on June 16, 2006. Firm initiated recall is ongoing.</p><p>REASON</p><p>Possible contamination of animal feeds with ruminent derived meat and bone</p><p>meal.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>10,878.06 tons</p><p>DISTRIBUTION</p><p>Nationwide</p><p></p><p>END OF ENFORCEMENT REPORT FOR July 12, 2006</p><p></p><p>###</p><p></p><p><a href="http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00960.html</a></p><p></p><p></p><p>Subject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006</p><p>Date: June 27, 2006 at 7:42 am PST</p><p>Public Health Service</p><p>Food and Drug Administration</p><p></p><p>New Orleans District</p><p>297 Plus Park Blvd.</p><p>Nashville, TN 37217</p><p></p><p>Telephone: 615-781-5380</p><p>Fax: 615-781-5391</p><p></p><p>May 17, 2006</p><p></p><p>WARNING LETTER NO. 2006-NOL-06</p><p></p><p>FEDERAL EXPRESS</p><p>OVERNIGHT DELIVERY</p><p></p><p>Mr. William Shirley, Jr., Owner</p><p>Louisiana.DBA Riegel By-Products</p><p>2621 State Street</p><p>Dallas, Texas 75204</p><p></p><p>Dear Mr. Shirley:</p><p></p><p>On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration</p><p>(FDA) investigator inspected your rendering plant, located at 509 Fortson</p><p>Street, Shreveport, Louisiana. The inspection revealed significant</p><p>deviations from the requirements set forth in Title 21, Code of Federal</p><p>Regulations, Part 589.2000 [21 CFR 589.2000], Animal Proteins Prohibited in</p><p>Ruminant Feed. This regulation is intended to prevent the establishment and</p><p>amplification of Bovine Spongiform Encephalopathy (BSE). You failed to</p><p>follow the requirements of this regulation; products being manufactured and</p><p>distributed by your facility are misbranded within the meaning of Section</p><p>403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act</p><p>(the Act).</p><p></p><p>Our investigation found you failed to provide measures, including sufficient</p><p>written procedures, to prevent commingling or cross-contamination and to</p><p>maintain sufficient written procedures [21 CFR 589.2000(e)] because:</p><p></p><p>You failed to use clean-out procedures or other means adequate to prevent</p><p>carryover of protein derived from mammalian tissues into animal protein or</p><p>feeds which may be used for ruminants. For example, your facility uses the</p><p>same equipment to process mammalian and poultry tissues. However, you use</p><p>only hot water to clean the cookers between processing tissues from each</p><p>species. You do not clean the auger, hammer mill, grinder, and spouts after</p><p>processing mammalian tissues.</p><p></p><p>You failed to maintain written procedures specifying the clean-out</p><p>procedures or other means to prevent carryover of protein derived from</p><p>mammalian tissues into feeds which may be used for ruminants.</p><p></p><p>As a result . the poultry meal you manufacture may contain protein derived</p><p>from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR</p><p>589.2000(e)(1)(i), any products containing or may contain protein derived</p><p>from mammalian tissues must be labeled, "Do not feed to cattle or other</p><p>ruminants." Since you failed to label a product which may contain protein</p><p>derived from mammalian tissues with the required cautionary statement. the</p><p>poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the</p><p>Act.</p><p></p><p>This letter is not intended as an all-inclusive list of violations at your</p><p>facility. As a manufacturer of materials intended for animal feed use, you</p><p>are responsible for ensuring your overall operation and the products you</p><p>manufacture and distribute are in compliance with the law. You should take</p><p>prompt action to correct these violations, and you should establish a system</p><p>whereby violations do not recur. Failure to promptly correct these</p><p>violations may result in regulatory action, such as seizure and/or</p><p>injunction, without further notice.</p><p></p><p>You should notify this office in writing within 15 working days of receiving</p><p>this letter, outlining the specific steps you have taken to bring your firm</p><p>into compliance with the law. Your response should include an explanation of</p><p>each step taken to correct the violations and prevent their recurrence. If</p><p>corrective action cannot be completed within 15 working days, state the</p><p>reason for the delay and the date by which the corrections will be</p><p>completed. Include copies of any available documentation demonstrating</p><p>corrections have been made.</p><p></p><p>Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S.</p><p>Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie,</p><p>Louisiana 70001. If you have questions regarding any issue in this letter,</p><p>please contact Mr. Rivero at (504) 219-8818, extension 103.</p><p></p><p>Sincerely,</p><p></p><p>/S</p><p></p><p>Carol S. Sanchez</p><p>Acting District Director</p><p>New Orleans District</p><p></p><p></p><p><a href="http://www.fda.gov/foi/warning_letters/g5883d.htm" target="_blank">http://www.fda.gov/foi/warning_letters/g5883d.htm</a></p><p></p><p>[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk</p><p>Materials for Human Food and Requirement for the Disposition of</p><p>Non-Ambulatory Disabled Cattle</p><p></p><p>03-025IFA</p><p>03-025IFA-2</p><p></p><p><a href="http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf" target="_blank">http://www.fsis.usda.gov/OPPDE/Comments ... 5IFA-2.pdf</a></p><p></p><p>Docket Management Docket: 02N-0273 - Substances Prohibited From Use in</p><p></p><p>Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed</p><p></p><p>Comment Number: EC -10</p><p></p><p>Accepted - Volume 2</p><p></p><p></p><p><a href="http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html" target="_blank">http://www.fda.gov/ohrms/dockets/dailys ... 4be07.html</a></p><p></p><p>PART 2</p><p></p><p></p><p><a href="http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html" target="_blank">http://www.fda.gov/ohrms/dockets/dailys ... 4be09.html</a></p><p></p><p></p><p>Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL</p><p>IMPORTS FROM CANADA</p><p></p><p></p><p><a href="https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed" target="_blank">https://web01.aphis.usda.gov/BSEcom.nsf ... AutoFramed</a></p><p></p><p></p><p>Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE</p><p>SAFEGUARDS (comment submission)</p><p></p><p><a href="https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument" target="_blank">https://web01.aphis.usda.gov/regpublic. ... enDocument</a></p><p></p><p></p><p>EFSA concludes that the current GBR level of USA, CANADA, AND MEXICO is III,</p><p>i.e. it is likely but not confirmed that domestic cattle are (clinically or</p><p>pre-clinically) infected with the BSE-agent. As long as there are no</p><p>significant changes in rendering or feeding, the stability remains</p><p>extremely/very unstable.</p><p></p><p></p><p></p><p>EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR)</p><p>of Canada</p><p></p><p>Adopted July 2004 (Question N° EFSA-Q-2003-083)</p><p></p><p></p><p>[Last updated 08 September 2004]</p><p>[Publication Date 20 August 2004]</p><p></p><p></p><p><a href="http://www.efsa.europa.eu/en/science/tse_assessments/gbr_assessments/564.html" target="_blank">http://www.efsa.europa.eu/en/science/ts ... s/564.html</a></p><p></p><p></p><p>EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR)</p><p>of Mexico</p><p></p><p>Adopted July 2004 (Question N° EFSA-Q-2003-083)</p><p></p><p></p><p>[Last updated 08 September 2004]</p><p>[Publication Date 20 August 2004]</p><p></p><p></p><p><a href="http://www.efsa.europa.eu/en/science/tse_assessments/gbr_assessments/565.html" target="_blank">http://www.efsa.europa.eu/en/science/ts ... s/565.html</a></p><p></p><p></p><p>EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR)</p><p>of the United States of America (USA)</p><p></p><p>Adopted July 2004 (Question N° EFSA-Q-2003-083)</p><p></p><p></p><p>[Last updated 08 September 2004]</p><p>[Publication Date 20 August 2004]</p><p></p><p></p><p><a href="http://www.efsa.europa.eu/en/science/tse_assessments/gbr_assessments/573.html" target="_blank">http://www.efsa.europa.eu/en/science/ts ... s/573.html</a></p><p></p><p></p><p>I THINK that the FSIS, USDA, APHIS, FDA, and everyone else envolved in this</p><p>mess has had plenty of time to get this right, i mean just look at the feed</p><p>ban violations alone in 2006, let alone all years preveously, since the</p><p>partial and voluntary Aug. 4, 1997 ban was put into place. IN my opinion,</p><p>these industry friendly regulations and the agencies that put them into</p><p>place, or not, have all failed the public terribly. just how bad will only</p><p>be known in the years and decades to come, for there failure has exposed us</p><p>all to the mad cow agent, in more ways than one. the incubation period is</p><p>the only saving grace. maybe we will all die from something else before</p><p>clinical disease appears, maybe not. and even if the agent only appears to</p><p>infect and kill only a few in the years and decades to come, it</p><p>will not make right, what every federal agency failed to do, and that is</p><p>protect the consumer. ONLY by Gods grace and a mircale will this disease</p><p>disappear anytime soon, and I pray that it does. However, it will not be</p><p>from anything that any of these industry friendly agencies have done,</p><p>because what they have done is fail from day one with BSE regulations, and</p><p>they still fail today. YOUR only fooling yourself with the infamous Enhanced</p><p>June 2004 BSE surveillance system. THOSE test and protocols for them were</p><p>flawwed from day one, and everyone around the globe (except USDA/APHIS/FSIS)</p><p>knows it. I call for a redo of that same program, only this time lets use</p><p>the most sensitive testing, lets use proper protocol, and lets not cherry</p><p>pick the cows that are to be tested, or not. you cannot render a stumbling</p><p>and staggering suspect mad cow before any test at all, that's not fare</p><p>either. no more suspect BSE samples sitting on the shelves for 4 to 7+</p><p>months, and it should not take an act of Congress to finally get them</p><p>confirmed. FINALLY, THE BSE MRR POLICY MUST BE REPEALED, AND THE BSE GBR</p><p>RISK ASSESSMENTS MUST BE ADHERED TO, and strengthened to include all TSE.</p><p>anything less is not acceptable and will only amplify and spread the BSE/TSE</p><p>agent. ...</p><p></p><p></p><p>Terry S. Singletary Sr.</p><p>P.O. Box 42</p><p>Bacliff, Texas USA 77518</p><p></p><p></p><p>----- Original Message -----</p><p>From: "Terry S. Singeltary Sr."</p><p>To:</p><p>Sent: Saturday, August 26, 2006 12:05 PM</p><p>Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine</p><p>Spongiform Encephalopathy (BSE) {TSS}</p><p></p><p></p><p>From: Terry S. Singeltary Sr. [flounder9@verizon.net]</p><p></p><p>Sent: Monday, July 24, 2006 1:09 PM</p><p></p><p>To: FSIS RegulationsComments</p><p></p><p>Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine</p><p>Spongiform Encephalopathy (BSE)</p><p></p><p>Page 1 of 98</p><p></p><p>8/3/2006</p><p></p><p>Greetings FSIS,</p><p></p><p>snip...</p><p></p><p>snip...full text 98 pages ;</p><p></p><p><a href="http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf" target="_blank">http://www.fsis.usda.gov/OPPDE/Comments ... 0011-1.pdf</a></p><p></p><p></p><p>Terry S. Singeltary Sr.</p><p>P.O. Box 42</p><p>Bacliff, Texas USA 77518</p><p></p><p>#################### <a href="https://lists.aegee.org/bse-l.html" target="_blank">https://lists.aegee.org/bse-l.html</a> ####################</p></blockquote><p></p>
[QUOTE="flounder, post: 271810, member: 3519"] ----- Original Message ----- From: "Terry S. Singeltary Sr." <flounder9@verizon.net> To: <fsis.regulationscomments@fsis.usda.gov> Sent: Tuesday, September 12, 2006 10:54 AM Subject: Docket No. FSIS-2006-0011E - Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE) Update; Notice of Availability and Technical Meeting Date: September 12, 2006 at 8:49 am PST [Federal Register: September 12, 2006 (Volume 71, Number 176)] [Notices] [Page 53649-53650] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr12se06-33] ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS-2006-0011E] Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE) Update; Notice of Availability and Technical Meeting AGENCY: Food Safety and Inspection Service, USDA. ACTION: Notice of availability; reopening and extension of comment period. ----------------------------------------------------------------------- SUMMARY: The Food Safety and Inspection Service (FSIS) is reopening and extending the comment period for the 2005 updated Harvard Risk Assessment of bovine spongiform encephalopathy (BSE). The original comment period closed on August 11, 2006. The Agency is taking this action in response to a comment that was submitted after the Agency held its July 25, 2006, technical meeting to provide information on the updated risk assessment model and report. DATES: Comments are due by October 27, 2006. snip... [url=http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/2006-0011E.htm]http://www.fsis.usda.gov/Frame/FrameRed ... -0011E.htm[/url] Greetings FSIS, I must comment please, on ; Docket No. FSIS-2006-0011E - Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE) Update; Notice of Availability and Technical Meeting I hope that you don't need more time to let industry reps try and water this thing down as much as possible (just my opinion). HOWEVER, if you just look at was was promised to us on SRMs before, and then the after product, only then will you see just how industry friendly these regulations are. let's first take a look at what was first promised ; FOR IMMEDIATE RELEASE Monday, Jan. 26, 2004 FDA Press Office 301-827-6242 Expanded "Mad Cow" Safeguards Announced to Strengthen Existing Firewalls Against BSE Transmission HHS Secretary Tommy G. Thompson today announced several new public health measures, to be implemented by the Food and Drug Administration (FDA), to strengthen significantly the multiple existing firewalls that protect Americans from exposure to the agent thought to cause bovine spongiform encephalopathy (BSE, also known as mad cow disease) and that help prevent the spread of BSE in U.S. cattle. The existing multiple firewalls, developed by both the U.S. Department of Agriculture (USDA) and HHS, have been extremely effective in protecting the American consumer from exposure to BSE. The first firewall is based on import controls started in 1989. A second firewall is surveillance of the U.S. cattle population for the presence of BSE, a USDA firewall that led to the finding of the BSE cow in December. The third firewall is FDA's 1997 animal feed ban, which is the critical safeguard to help prevent the spread of BSE through cattle herds by prohibiting the feeding of most mammalian protein to ruminant animals, including cattle. The fourth firewall, recently announced by USDA, makes sure that no bovine tissues known to be at high risk for carrying the agent of BSE enter the human food supply regulated by USDA. The fifth firewall is effective response planning to contain the potential for any damage from a BSE positive animal, if one is discovered. This contingency response plan, which had been developed over the past several years, was initiated immediately upon the discovery of a BSE positive cow in Washington State December 23. The new safeguards being announced today are science-based and further bolster these already effective safeguards. Specifically, HHS intends to ban from human food (including dietary supplements), and cosmetics a wide range of bovine-derived material so that the same safeguards that protect Americans from exposure to the agent of BSE through meat products regulated by USDA also apply to food products that FDA regulates. FDA will also prohibit certain currently allowed feeding and manufacturing practices involving feed for cattle and other ruminant animals. These additional measures will further strengthen FDA's 1997 "animal feed" rule. "Today's actions will make strong public health protections against BSE even stronger," Secretary Thompson said. "Although the current animal feed rule provides a strong barrier against the further spread of BSE, we must never be satisfied with the status quo where the health and safety of our animals and our population is at stake. The science and our own experience and knowledge in this area are constantly evolving. Small as the risk may already be, this is the time to make sure the public is protected to the greatest extent possible." "Today we are bolstering our BSE firewalls to protect the public," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "We are further strengthening our animal feed rule, and we are taking additional steps to further protect the public from being exposed to any potentially risky materials from cattle. FDA's vigorous inspection and enforcement program has helped us achieve a compliance rate of more than 99 percent with the feed ban rule, and we intend to increase our enforcement efforts to assure compliance with our enhanced regulations. Finally, we are continuing to assist in the development of new technologies that will help us in the future improve even further these BSE protections. With today's actions, FDA will be doing more than ever before to protect the public against BSE by eliminating additional potential sources of BSE exposure." To implement these new protections, FDA will publish two interim final rules that will take effect immediately upon publication, although there will be an opportunity for public comment after publication. The first interim final rule will ban the following materials from FDA-regulated human food, (including dietary supplements) and cosmetics: * Any material from "downer" cattle. ("Downer" cattle are animals that cannot walk.) * Any material from "dead" cattle. ("Dead" cattle are cattle that die on the farm (i.e. before reaching the slaughter plant); * Specified Risk Materials (SRMs) that are known to harbor the highest concentrations of the infectious agent for BSE, such as the brain, skull, eyes, and spinal cord of cattle 30 months or older, and a portion of the small intestine and tonsils from all cattle, regardless of their age or health; and * The product known as mechanically separated beef, a product which may contain SRMs. Meat obtained by Advanced Meat Recovery (an automated system for cutting meat from bones), may be used since USDA regulations do not allow the presence of SRMs in this product. The second interim final rule is designed to lower even further the risk that cattle will be purposefully or inadvertently fed prohibited protein. It was the feeding of such protein to cattle that was the route of disease transmission that led to the BSE epidemic in United Kingdom cattle in the 1980's and 1990's. This interim final rule will implement four specific changes in FDA's present animal feed rule. First, the rule will eliminate the present exemption in the feed rule that allows mammalian blood and blood products to be fed to other ruminants as a protein source. Recent scientific evidence suggests that blood can carry some infectivity for BSE. Second, the rule will also ban the use of "poultry litter" as a feed ingredient for ruminant animals. Poultry litter consists of bedding, spilled feed, feathers, and fecal matter that are collected from living quarters where poultry is raised. This material is then used in cattle feed in some areas of the country where cattle and large poultry raising operations are located near each other. Poultry feed may legally contain protein that is prohibited in ruminant feed, such as bovine meat and bone meal. The concern is that spillage of poultry feed in the chicken house occurs and that poultry feed (which may contain protein prohibited in ruminant feed) is then collected as part of the "poultry litter" and added to ruminant feed. Third, the rule will ban the use of "plate waste" as a feed ingredient for ruminants. Plate waste consists of uneaten meat and other meat scraps that are currently collected from some large restaurant operations and rendered into meat and bone meal for animal feed. The use of "plate waste" confounds FDA's ability to analyze ruminant feeds for the presence of prohibited proteins, compromising the Agency's ability to fully enforce the animal feed rule. Fourth, the rule will further minimize the possibility of cross-contamination of ruminant and non-ruminant animal feed by requiring equipment, facilities or production lines to be dedicated to non-ruminant animal feeds if they use protein that is prohibited in ruminant feed. Currently, some equipment, facilities and production lines process or handle prohibited and non-prohibited materials and make both ruminant and non-ruminant feed -- a practice which could lead to cross-contamination. To accompany these new measures designed to provide a further layer of protection against BSE, FDA will in 2004 step up its inspections of feed mills and renderers. FDA will itself conduct 2,800 inspections and will make its resources go even further by continuing to work with state agencies to fund 3,100 contract inspections of feed mill and renderers and other firms that handle animal feed and feed ingredients. Through partnerships with states, FDA will also receive data on 700 additional inspections, for a total of 3,800 state contract and partnership inspections in 2004 alone, including annual inspections of 100 percent of all known renderers and feed mills that process products containing materials prohibited in ruminant feed. "We have worked hard with the rendering and animal feed production industries to try and achieve full compliance with the animal feed rule," said Dr. McClellan, "and through strong education and a vigorous enforcement campaign, backed by additional inspections and resources, we intend to maintain a high level of compliance." Dr. McClellan also noted that, in response to finding a BSE positive cow in Washington state December 23, FDA inspected and traced products at 22 facilities related to that positive cow or products from the cow, including feed mills, farms, dairy farms, calf feeder lots, slaughter houses, meat processors, transfer stations, and shipping terminals. Moreover, FDA has conducted inspections at the rendering facilities that handled materials from the positive cow, and they were found to be fully in compliance with FDA's feed rule. To further strengthen protections for Americans, FDA/HHS intends to work with Congress to consider proposals to assure that these important protective measures will be implemented as effectively as possible. FDA is also continuing its efforts to assist in the development of better BSE science, to achieve the same or greater confidence in BSE protection at a lower cost. For example, to enhance the ability of our public health system to detect prohibited materials in animal feed, FDA will continue to support the development and evaluation of diagnostic tests to identify prohibited materials. These tests would offer a quick and reliable method of testing animal feeds for prohibited materials and for testing other products for contamination with the agent thought to cause BSE. FDA has publicly discussed many of the measures being announced today with stakeholders in workshops, videoconferences, and public meetings. In addition, FDA published an Advance Notice of Proposed Rulemaking in November 2002 (available online at [url=http://www.fda.gov/OHRMS/DOCKETS/98fr/110602c.htm]http://www.fda.gov/OHRMS/DOCKETS/98fr/110602c.htm[/url] concerning possible changes to the animal feed rule. Comprehensive information about FDA's work on BSE and links to other related websites are available at [url=http://www.fda.gov]http://www.fda.gov[/url]. ### [url=http://www.fda.gov/bbs/topics/news/2004/hhs_012604.html]http://www.fda.gov/bbs/topics/news/2004/hhs_012604.html[/url] YEP, were still waiting. WHILE were still waiting, the agent is still amplifying and spreading through these...... how are they called ; Expanded "Mad Cow" Safeguards Announced to Strengthen Existing Firewalls Against BSE Transmission or The existing multiple firewalls, developed by both the U.S. Department of Agriculture (USDA) and HHS, have been extremely effective in protecting the American consumer from exposure to BSE. LET US LOOK at these 'expanded, existing, firewalls, and just HOW MUCH POTENTIAL MAD COW FEED they are speaking of IN COMMERCE IN 2006 ALONE. for those that think i exploit these as.... how was it put to me recently on me posting these recalls as only a 'potential hazard' and that the feed in question was not obvious from 'BSE covert animals' and that would only be true IF there were a BSE surveillance system in the USA that was set up to FIND BSE cases. I think it has well been astablished that this is not the case. IN fact Paul Brown said about the enfamous June 2004 Enhanced BSE cover-up ; CDC DR. PAUL BROWN TSE EXPERT COMMENTS 2006 The U.S. Department of Agriculture was quick to assure the public earlier this week that the third case of mad cow disease did not pose a risk to them, but what federal officials have not acknowledged is that this latest case indicates the deadly disease has been circulating in U.S. herds for at least a decade. The second case, which was detected last year in a Texas cow and which USDA officials were reluctant to verify, was approximately 12 years old. These two cases (the latest was detected in an Alabama cow) present a picture of the disease having been here for 10 years or so, since it is thought that cows usually contract the disease from contaminated feed they consume as calves. The concern is that humans can contract a fatal, incurable, brain-wasting illness from consuming beef products contaminated with the mad cow pathogen. "The fact the Texas cow showed up fairly clearly implied the existence of other undetected cases," Dr. Paul Brown, former medical director of the National Institutes of Health's Laboratory for Central Nervous System Studies and an expert on mad cow-like diseases, told United Press International. "The question was, 'How many?' and we still can't answer that." Brown, who is preparing a scientific paper based on the latest two mad cow cases to estimate the maximum number of infected cows that occurred in the United States, said he has "absolutely no confidence in USDA tests before one year ago" because of the agency's reluctance to retest the Texas cow that initially tested positive. USDA officials finally retested the cow and confirmed it was infected seven months later, but only at the insistence of the agency's inspector general. "Everything they did on the Texas cow makes everything USDA did before 2005 suspect," Brown said. ...snip...end [url=http://www.upi.com/ConsumerHealthDaily/view.php?StoryID=20060315-055557-1284r]http://www.upi.com/ConsumerHealthDaily/ ... 5557-1284r[/url] AND NOT TO FORGET what the OIG has said time and time again over the years; [url=http://www.usda.gov/oig/webdocs/50601-10-KC.pdf]http://www.usda.gov/oig/webdocs/50601-10-KC.pdf[/url] 03-025IF 03-025IF-631 Linda A. Detwiler [PDF] [url=http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-631.pdf]http://www.fsis.usda.gov/OPPDE/Comments ... IF-631.pdf[/url] Specified Risk Materials (SRMs) I am in full support of the interim final rule which prohibits SRMs from being included in food for human consumption. In addition to the list of tissues published in this rule, I am requesting that additional tissues be added to the list. These would include dura ("sheath") covering the spinal cord and the ENTIRE INTESTINE (from pylorus to rectum). The scientific justification is provided below. THESE SRMs should also be prohibited from ANY FDA regulated food or product intended for human consumption, including but not limited to flavorings, extracts, etc. ... Dr. Linda Detwiler comments in full; [url=http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-634.pdf]http://www.fsis.usda.gov/OPPDE/Comments ... IF-634.pdf[/url] [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirement for the Disposition of Non-Ambulatory Disabled Cattle [url=http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000534-01-vol45.pdf]http://www.fda.gov/ohrms/dockets/docket ... -vol45.pdf[/url] [url=http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf]http://www.fda.gov/ohrms/dockets/docket ... -vol40.pdf[/url] THE SEVEN 1/2 SCIENTIST REPORT *** ;-) [url=http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf]http://www.fda.gov/ohrms/dockets/docket ... tach-1.pdf[/url] [url=https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument]https://web01.aphis.usda.gov/regpublic. ... enDocument[/url] [url=http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdf]http://www.fda.gov/ohrms/dockets/docket ... -vol35.pdf[/url] SO, let me exploit these FACTS again. I mean these feeders are still laughing all the way to the bank, while spreading the mad cow agent to hell and back in the USA ; Subject: MAD COW FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL, TN, AND WV Date: September 6, 2006 at 7:58 am PST PRODUCT a) EVSRC Custom dairy feed, Recall # V-130-6; b) Performance Chick Starter, Recall # V-131-6; c) Performance Quail Grower, Recall # V-132-6; d) Performance Pheasant Finisher, Recall # V-133-6. CODE None RECALLING FIRM/MANUFACTURER Donaldson & Hasenbein/dba J&R Feed Service, Inc., Cullman, AL, by telephone on June 23, 2006 and by letter dated July 19, 2006. Firm initiated recall is complete. REASON Dairy and poultry feeds were possibly contaminated with ruminant based protein. VOLUME OF PRODUCT IN COMMERCE 477.72 tons DISTRIBUTION AL ______________________________ PRODUCT a) Dairy feed, custom, Recall # V-134-6; b) Custom Dairy Feed with Monensin, Recall # V-135-6. CODE None. Bulk product RECALLING FIRM/MANUFACTURER Recalling Firm: Burkmann Feed, Greeneville, TN, by Telephone beginning on June 28, 2006. Manufacturer: H. J. Baker & Bro., Inc., Albertville, AL. Firm initiated recall is complete. REASON Possible contamination of dairy feeds with ruminant derived meat and bone meal. VOLUME OF PRODUCT IN COMMERCE 1,484 tons DISTRIBUTION TN and WV [url=http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00968.html[/url] Subject: MAD COW FEED RECALLS ENFORCEMENT REPORT FOR AUGUST 9, 2006 KY, LA, MS, AL, GA, AND TN 11,000+ TONS Date: August 16, 2006 at 9:19 am PST RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II ______________________________ PRODUCT Bulk custom made dairy feed, Recall # V-115-6 CODE None RECALLING FIRM/MANUFACTURER Hiseville Feed & Seed Co., Hiseville, KY, by telephone and letter on or about July 14, 2006. FDA initiated recall is ongoing. REASON Custom made feeds contain ingredient called Pro-Lak which may contain ruminant derived meat and bone meal. VOLUME OF PRODUCT IN COMMERCE Approximately 2,223 tons DISTRIBUTION KY ______________________________ PRODUCT Bulk custom made dairy feed, Recall # V-116-6 CODE None RECALLING FIRM/MANUFACTURER Rips Farm Center, Tollesboro, KY, by telephone and letter on July 14, 2006. FDA initiated recall is ongoing. REASON Custom made feeds contain ingredient called Pro-Lak which may contain ruminant derived meat and bone meal. VOLUME OF PRODUCT IN COMMERCE 1,220 tons DISTRIBUTION KY ______________________________ PRODUCT Bulk custom made dairy feed, Recall # V-117-6 CODE None RECALLING FIRM/MANUFACTURER Kentwood Co-op, Kentwood, LA, by telephone on June 27, 2006. FDA initiated recall is completed. REASON Possible contamination of animal feed ingredients, including ingredients that are used in feed for dairy animals, with ruminant derived meat and bone meal. VOLUME OF PRODUCT IN COMMERCE 40 tons DISTRIBUTION LA and MS ______________________________ PRODUCT Bulk Dairy Feed, Recall V-118-6 CODE None RECALLING FIRM/MANUFACTURER Cal Maine Foods, Inc., Edwards, MS, by telephone on June 26, 2006. FDA initiated recall is complete. REASON Possible contamination of animal feed ingredients, including ingredients that are used in feed for dairy animals, with ruminant derived meat and bone meal. VOLUME OF PRODUCT IN COMMERCE 7,150 tons DISTRIBUTION MS ______________________________ PRODUCT Bulk custom dairy pre-mixes, Recall # V-119-6 CODE None RECALLING FIRM/MANUFACTURER Walthall County Co-op, Tylertown, MS, by telephone on June 26, 2006. Firm initiated recall is complete. REASON Possible contamination of dairy animal feeds with ruminant derived meat and bone meal. VOLUME OF PRODUCT IN COMMERCE 87 tons DISTRIBUTION MS ______________________________ PRODUCT Bulk custom dairy pre-mixes, Recall # V-120-6 CODE None RECALLING FIRM/MANUFACTURER Ware Milling Inc., Houston, MS, by telephone on June 23, 2006. Firm initiated recall is complete. REASON Possible contamination of dairy animal feeds with ruminant derived meat and bone meal. VOLUME OF PRODUCT IN COMMERCE 350 tons DISTRIBUTION AL and MS ______________________________ PRODUCT a) Tucker Milling, LLC Tm 32% Sinking Fish Grower, #2680-Pellet, 50 lb. bags, Recall # V-121-6; b) Tucker Milling, LLC #31120, Game Bird Breeder Pellet, 50 lb. bags, Recall # V-122-6; c) Tucker Milling, LLC #31232 Game Bird Grower, 50 lb. bags, Recall # V-123-6; d) Tucker Milling, LLC 31227-Crumble, Game Bird Starter, BMD Medicated, 50 lb bags, Recall # V-124-6; e) Tucker Milling, LLC #31120, Game Bird Breeder, 50 lb bags, Recall # V-125-6; f) Tucker Milling, LLC #30230, 30 % Turkey Starter, 50 lb bags, Recall # V-126-6; g) Tucker Milling, LLC #30116, TM Broiler Finisher, 50 lb bags, Recall # V-127-6 CODE All products manufactured from 02/01/2005 until 06/20/2006 RECALLING FIRM/MANUFACTURER Recalling Firm: Tucker Milling LLC, Guntersville, AL, by telephone and visit on June 20, 2006, and by letter on June 23, 2006. Manufacturer: H. J. Baker and Brothers Inc., Stamford, CT. Firm initiated recall is ongoing. REASON Poultry and fish feeds which were possibly contaminated with ruminant based protein were not labeled as "Do not feed to ruminants". VOLUME OF PRODUCT IN COMMERCE 7,541-50 lb bags DISTRIBUTION AL, GA, MS, and TN END OF ENFORCEMENT REPORT FOR AUGUST 9, 2006 ### [url=http://www.fda.gov/bbs/topics/ENFORCE/2006/ENF00964.html]http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00964.html[/url] Subject: MAD COW FEED RECALL MI MAMMALIAN PROTEIN VOLUME OF PRODUCT IN COMMERCE 27,694,240 lbs Date: August 6, 2006 at 6:14 pm PST PRODUCT Bulk custom dairy feds manufactured from concentrates, Recall # V-113-6 CODE All dairy feeds produced between 2/1/05 and 6/16/06 and containing H. J. Baker recalled feed products. RECALLING FIRM/MANUFACTURER Vita Plus Corp., Gagetown, MI, by visit beginning on June 21, 2006. Firm initiated recall is complete. REASON The feed was manufactured from materials that may have been contaminated with mammalian protein. VOLUME OF PRODUCT IN COMMERCE 27,694,240 lbs DISTRIBUTION MI END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006 ### [url=http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00963.html[/url] Subject: MAD COW FEED RECALL AL AND FL VOLUME OF PRODUCT IN COMMERCE 125 TONS Products manufactured from 02/01/2005 until 06/06/2006 Date: August 6, 2006 at 6:16 pm PST PRODUCT a) CO-OP 32% Sinking Catfish, Recall # V-100-6; b) Performance Sheep Pell W/Decox/A/N, medicated, net wt. 50 lbs, Recall # V-101-6; c) Pro 40% Swine Conc Meal -- 50 lb, Recall # V-102-6; d) CO-OP 32% Sinking Catfish Food Medicated, Recall # V-103-6; e) "Big Jim's" BBB Deer Ration, Big Buck Blend, Recall # V-104-6; f) CO-OP 40% Hog Supplement Medicated Pelleted, Tylosin 100 grams/ton, 50 lb. bag, Recall # V-105-6; g) Pig Starter Pell II, 18% W/MCDX Medicated 282020, Carbadox -- 0.0055%, Recall # V-106-6; h) CO-OP STARTER-GROWER CRUMBLES, Complete Feed for Chickens from Hatch to 20 Weeks, Medicated, Bacitracin Methylene Disalicylate, 25 and 50 Lbs, Recall # V-107-6; i) CO-OP LAYING PELLETS, Complete Feed for Laying Chickens, Recall # 108-6; j) CO-OP LAYING CRUMBLES, Recall # V-109-6; k) CO-OP QUAIL FLIGHT CONDITIONER MEDICATED, net wt 50 Lbs, Recall # V-110-6; l) CO-OP QUAIL STARTER MEDICATED, Net Wt. 50 Lbs, Recall # V-111-6; m) CO-OP QUAIL GROWER MEDICATED, 50 Lbs, Recall # V-112-6 CODE Product manufactured from 02/01/2005 until 06/06/2006 RECALLING FIRM/MANUFACTURER Alabama Farmers Cooperative, Inc., Decatur, AL, by telephone, fax, email and visit on June 9, 2006. FDA initiated recall is complete. REASON Animal and fish feeds which were possibly contaminated with ruminant based protein not labeled as "Do not feed to ruminants". VOLUME OF PRODUCT IN COMMERCE 125 tons DISTRIBUTION AL and FL END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006 ### [url=http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00963.html[/url] Subject: MAD COW FEED RECALL KY VOLUME OF PRODUCT IN COMMERCE ????? Date: August 6, 2006 at 6:19 pm PST PRODUCT Bulk custom made dairy feed, Recall # V-114-6 CODE None RECALLING FIRM/MANUFACTURER Burkmann Feeds LLC, Glasgow, KY, by letter on July 14, 2006. Firm initiated recall is ongoing. REASON Custom made feeds contain ingredient called Pro-Lak, which may contain ruminant derived meat and bone meal. VOLUME OF PRODUCT IN COMMERCE ????? DISTRIBUTION KY END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006 ### [url=http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00963.html[/url] CJD WATCH MESSAGE BOARD TSS MAD COW FEED RECALL USA EQUALS 10,878.06 TONS NATIONWIDE Sun Jul 16, 2006 09:22 71.248.128.67 RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II ______________________________ PRODUCT a) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals, Recall # V-079-6; b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg), Recall # V-080-6; c) PRO-PAK, MARINE & ANIMAL PROTEIN CONCENTRATE FOR USE IN ANIMAL FEED, Recall # V-081-6; d) Feather Meal, Recall # V-082-6 CODE a) Bulk b) None c) Bulk d) Bulk RECALLING FIRM/MANUFACTURER H. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 and by press release on June 16, 2006. Firm initiated recall is ongoing. REASON Possible contamination of animal feeds with ruminent derived meat and bone meal. VOLUME OF PRODUCT IN COMMERCE 10,878.06 tons DISTRIBUTION Nationwide END OF ENFORCEMENT REPORT FOR July 12, 2006 ### [url=http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00960.html[/url] Subject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006 Date: June 27, 2006 at 7:42 am PST Public Health Service Food and Drug Administration New Orleans District 297 Plus Park Blvd. Nashville, TN 37217 Telephone: 615-781-5380 Fax: 615-781-5391 May 17, 2006 WARNING LETTER NO. 2006-NOL-06 FEDERAL EXPRESS OVERNIGHT DELIVERY Mr. William Shirley, Jr., Owner Louisiana.DBA Riegel By-Products 2621 State Street Dallas, Texas 75204 Dear Mr. Shirley: On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration (FDA) investigator inspected your rendering plant, located at 509 Fortson Street, Shreveport, Louisiana. The inspection revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 [21 CFR 589.2000], Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). You failed to follow the requirements of this regulation; products being manufactured and distributed by your facility are misbranded within the meaning of Section 403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act (the Act). Our investigation found you failed to provide measures, including sufficient written procedures, to prevent commingling or cross-contamination and to maintain sufficient written procedures [21 CFR 589.2000(e)] because: You failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues into animal protein or feeds which may be used for ruminants. For example, your facility uses the same equipment to process mammalian and poultry tissues. However, you use only hot water to clean the cookers between processing tissues from each species. You do not clean the auger, hammer mill, grinder, and spouts after processing mammalian tissues. You failed to maintain written procedures specifying the clean-out procedures or other means to prevent carryover of protein derived from mammalian tissues into feeds which may be used for ruminants. As a result . the poultry meal you manufacture may contain protein derived from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR 589.2000(e)(1)(i), any products containing or may contain protein derived from mammalian tissues must be labeled, "Do not feed to cattle or other ruminants." Since you failed to label a product which may contain protein derived from mammalian tissues with the required cautionary statement. the poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the Act. This letter is not intended as an all-inclusive list of violations at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring your overall operation and the products you manufacture and distribute are in compliance with the law. You should take prompt action to correct these violations, and you should establish a system whereby violations do not recur. Failure to promptly correct these violations may result in regulatory action, such as seizure and/or injunction, without further notice. You should notify this office in writing within 15 working days of receiving this letter, outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating corrections have been made. Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S. Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie, Louisiana 70001. If you have questions regarding any issue in this letter, please contact Mr. Rivero at (504) 219-8818, extension 103. Sincerely, /S Carol S. Sanchez Acting District Director New Orleans District [url=http://www.fda.gov/foi/warning_letters/g5883d.htm]http://www.fda.gov/foi/warning_letters/g5883d.htm[/url] [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirement for the Disposition of Non-Ambulatory Disabled Cattle 03-025IFA 03-025IFA-2 [url=http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf]http://www.fsis.usda.gov/OPPDE/Comments ... 5IFA-2.pdf[/url] Docket Management Docket: 02N-0273 - Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed Comment Number: EC -10 Accepted - Volume 2 [url=http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html]http://www.fda.gov/ohrms/dockets/dailys ... 4be07.html[/url] PART 2 [url=http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html]http://www.fda.gov/ohrms/dockets/dailys ... 4be09.html[/url] Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL IMPORTS FROM CANADA [url=https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed]https://web01.aphis.usda.gov/BSEcom.nsf ... AutoFramed[/url] Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission) [url=https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument]https://web01.aphis.usda.gov/regpublic. ... enDocument[/url] EFSA concludes that the current GBR level of USA, CANADA, AND MEXICO is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as there are no significant changes in rendering or feeding, the stability remains extremely/very unstable. EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of Canada Adopted July 2004 (Question N° EFSA-Q-2003-083) [Last updated 08 September 2004] [Publication Date 20 August 2004] [url=http://www.efsa.europa.eu/en/science/tse_assessments/gbr_assessments/564.html]http://www.efsa.europa.eu/en/science/ts ... s/564.html[/url] EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of Mexico Adopted July 2004 (Question N° EFSA-Q-2003-083) [Last updated 08 September 2004] [Publication Date 20 August 2004] [url=http://www.efsa.europa.eu/en/science/tse_assessments/gbr_assessments/565.html]http://www.efsa.europa.eu/en/science/ts ... s/565.html[/url] EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA) Adopted July 2004 (Question N° EFSA-Q-2003-083) [Last updated 08 September 2004] [Publication Date 20 August 2004] [url=http://www.efsa.europa.eu/en/science/tse_assessments/gbr_assessments/573.html]http://www.efsa.europa.eu/en/science/ts ... s/573.html[/url] I THINK that the FSIS, USDA, APHIS, FDA, and everyone else envolved in this mess has had plenty of time to get this right, i mean just look at the feed ban violations alone in 2006, let alone all years preveously, since the partial and voluntary Aug. 4, 1997 ban was put into place. IN my opinion, these industry friendly regulations and the agencies that put them into place, or not, have all failed the public terribly. just how bad will only be known in the years and decades to come, for there failure has exposed us all to the mad cow agent, in more ways than one. the incubation period is the only saving grace. maybe we will all die from something else before clinical disease appears, maybe not. and even if the agent only appears to infect and kill only a few in the years and decades to come, it will not make right, what every federal agency failed to do, and that is protect the consumer. ONLY by Gods grace and a mircale will this disease disappear anytime soon, and I pray that it does. However, it will not be from anything that any of these industry friendly agencies have done, because what they have done is fail from day one with BSE regulations, and they still fail today. YOUR only fooling yourself with the infamous Enhanced June 2004 BSE surveillance system. THOSE test and protocols for them were flawwed from day one, and everyone around the globe (except USDA/APHIS/FSIS) knows it. I call for a redo of that same program, only this time lets use the most sensitive testing, lets use proper protocol, and lets not cherry pick the cows that are to be tested, or not. you cannot render a stumbling and staggering suspect mad cow before any test at all, that's not fare either. no more suspect BSE samples sitting on the shelves for 4 to 7+ months, and it should not take an act of Congress to finally get them confirmed. FINALLY, THE BSE MRR POLICY MUST BE REPEALED, AND THE BSE GBR RISK ASSESSMENTS MUST BE ADHERED TO, and strengthened to include all TSE. anything less is not acceptable and will only amplify and spread the BSE/TSE agent. ... Terry S. Singletary Sr. P.O. Box 42 Bacliff, Texas USA 77518 ----- Original Message ----- From: "Terry S. Singeltary Sr." To: Sent: Saturday, August 26, 2006 12:05 PM Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE) {TSS} From: Terry S. Singeltary Sr. [flounder9@verizon.net] Sent: Monday, July 24, 2006 1:09 PM To: FSIS RegulationsComments Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE) Page 1 of 98 8/3/2006 Greetings FSIS, snip... snip...full text 98 pages ; [url=http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf]http://www.fsis.usda.gov/OPPDE/Comments ... 0011-1.pdf[/url] Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518 #################### [url=https://lists.aegee.org/bse-l.html]https://lists.aegee.org/bse-l.html[/url] #################### [/QUOTE]
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Docket No. FSIS-2006-0011E - Harvard Risk Assessment of BSE
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