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NCBA, R-CALF, COOL, USDA (No Politics!)
Agriculture Secretary Mike Johanns Gaggle regarding Japanese
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<blockquote data-quote="flounder" data-source="post: 236515" data-attributes="member: 3519"><p>##################### Bovine Spongiform Encephalopathy #####################</p><p></p><p>Subject: Agriculture Secretary Mike Johanns Gaggle regarding Japanese Beef Issues</p><p>Date: June 27, 2006 at 6:37 pm PST </p><p>Release No. 0221.06</p><p>Contact:</p><p>Press Office (202)720-4623 </p><p></p><p></p><p></p><p>Agriculture Secretary Mike Johanns Gaggle regarding Japanese Beef Issues. </p><p></p><p>June 27, 2006 </p><p></p><p>SEC. JOHANNS: The audit teams are here in the United States, and every indication so far is that things are going just fine. I think they've been in three plants if I have my information correct, and as I've said it appears like we're moving along well through the audits, and everything is on track. I haven't been made aware of any significant problems that have developed either in the audits or in the process moving through the audits. I do want to indicate also that I just think the comments from Japan are very encouraging these days, and it's especially encouraging to see the comment that one problem with the shipment would not stop trade, that they would deal with the individual plant. That's a message that we talked about before many, many months now. So I am very encouraged. We're anxious to get through the audits, deal with whatever issues are there. But so far so good. </p><p></p><p>REPORTER: Any further assurances when Mr. Koizumi -- </p><p></p><p>SEC. JOHANNS: I think we're in good shape. I'm not sure if it will come up or not. I certainly have not raised the issue with the President. They've worked together for five years, and I suspect they have a wide range of issues to talk about. But I think so far so good. I think we're doing well, and like I said the audits seem to be going fine. </p><p></p><p>REPORTER: -- right after the agreements (unclear) in their work and that you're not satisfied. Can you elaborate? </p><p></p><p>SEC. JOHANNS: The only point I wanted to make is that the agreement was a step. It was, I didn't want anybody to have the impression that somehow beef was heading back to Japan. We still have some process to get through here. So that's the point I wanted to make. I especially didn't want anyone on the Hill, House or Senate side, to feel like they were being misled that somehow I had reached an agreement and beef was moving back into Japan. It is not. We've got a ways to go yet. </p><p></p><p>REPORTER: Mr. Secretary, if when the audits are complete if they find any problems with individual plants, would you, A, go ahead with trade? Or B, wait until all the plants are approved? </p><p></p><p>SEC. JOHANNS: We faced that issue with Korea as you know, and we believe very, very strongly in our system. And so what we are doing is working through those individual plant issues. And that' what I would intend to do with Japan. Now again I will stress to you, Bill, if we find a plant that is not ready for shipment into Japan, we simply are going to take action on our own to make sure that they are not part of the original group. But that really I see as a United States decision. I don't see that as anything like that. So the point is we see our system as a whole system. This is not about individual pick and choose and we'll take this plant but not that plant. We really want to move this full process all at once. If in the process the United States finds a plant that's problematic and not ready for shipment, we would set them to the side. But I don't think we're going to see that. </p><p></p><p>REPORTER: -- curing the problem, the whole market is shut down because of one plant. </p><p></p><p>SEC. JOHANNS: Well, if the plant is not ready, we'll solve that problem. </p><p></p><p>REPORTER: But how do you deal with it in the future if we have a single or double plant problem, Japanese want to shut down the whole market? </p><p></p><p>SEC. JOHANNS: Well, that becomes a very serious problem. I mean this time we decided it's best to work through it, but my hope is we don't go that way again any more than I would argue we should shut down their whole automobile market because we find a defective car. </p><p></p><p>REPORTER: But they've not agreed to anything? </p><p></p><p>SEC. JOHANNS: Well, the indications are positive. But the indications are that if they are wiling to work with us then that is positive. </p><p></p><p>REPORTER: Are you satisfied with the conditions set by Japan? </p><p></p><p>SEC. JOHANNS: So far so good. I mean we're still working through issues, and so give me some leeway there. But so far so good. I think we're headed toward successful audits and markets reopening. </p><p></p><p>REPORTER: Mr. Secretary, what was your reaction to Canada's imposition of its strict feed rule yesterday? </p><p></p><p>SEC. JOHANNS: I talked to the Minister of Agriculture over the weekend, and he indicated to me that that's where they were headed. And so first thing I would say is, that it was not a surprise. They gave us a heads up and indicated to us why they felt they needed to do this. As you know, they identified some cases of BSE in Canada, and so I guess beyond that my reaction is that it's a decision Canada can make and I was pleased to be forewarned. </p><p></p><p>REPORTER: Mr. Secretary, do you think that the Canadian feed rule is an advantage in exporting to Japan? And has FDA given you any indication of when the U.S. will come out with their revision? </p><p></p><p>SEC. JOHANNS: I don't know when the FDA will come out with a revised approach here. I don't think so. You know, we have found so little BSE in the United States. It's just virtually nonexistent. Plus international standards. I do think the world is moving toward (unclear) international standards, and so I don't think it gives them a particular advantage. </p><p></p><p>REPORTER: Mr. Secretary, for the nonbeef crowd I just wondered if you anticipate following the same model as you followed with Korea, meaning waiting for all U.S. plants except for the example you gave? </p><p></p><p>SEC. JOHANNS: We want all plants approved. </p><p></p><p>REPORTER: So (unclear) the same with Japan? </p><p></p><p>SEC. JOHANNS: Well, I hope we don't face it. But if we do we will work to get all plants approved. Again, if there's a single plant that's not ready for shipment we make that determination here in the United States, that's a different matter. But we see our whole system as a system that approves all plants and that's where we want to -- </p><p></p><p>REPORTER: How would you decide a plant is not ready for shipment? </p><p></p><p>SEC. JOHANNS: Oh, I think there would be some obvious examples. If they just simply don't understand the system, haven't done the training, haven't followed the steps that we put in place, then that's pretty obvious to us that they're not ready for beef shipments to Japan. </p><p></p><p>REPORTER: -- adjust on policy, standards, would that be (unclear) disqualify them? </p><p></p><p>SEC. JOHANNS: I think we'd walk through the specifics here because it gets so hypothetical. But here's my point. My point is that if Japan sees some paperwork issues and the issues have been solved, readily solved, then we want all plants to move together. If on the other hand we say look, we found training deficiencies, we found employees that didn't understand the rules, and this is just not going to work, and we looked at it and said, yeah, they're not ready for shipment to Japan, we're going to let that happen. My belief is that plants that wanted a certain (unclear) be ready. Okay. </p><p></p><p></p><p></p><p></p><p><a href="http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB/.cmd/ad/.ar/sa.retrievecontent/.c/6_2_1UH/.ce/7_2_5JM/.p/5_2_4TQ/.d/2/_th/J_2_9D/_s.7_0_A/7_0_1OB?PC_7_2_5JM_contentid=2006%2F06%2F0221.xml&PC_7_2_5JM_parentnav=TRANSCRIPTS_SPEECHES&PC_7_2_5JM_navid=TRANSCRIPT#7_2_5JM" target="_blank">http://www.usda.gov/wps/portal/!ut/p/_s ... PT#7_2_5JM</a> </p><p></p><p></p><p></p><p></p><p>Japan would be very very irresponsible to it's consumer to start importing TSE from the USA. ...TSS</p><p></p><p>#################### <a href="https://lists.aegee.org/bse-l.html" target="_blank">https://lists.aegee.org/bse-l.html</a> ####################</p><p></p><p></p><p>##################### Bovine Spongiform Encephalopathy #####################</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></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 (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). </p><p></p><p>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: </p><p></p><p>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. </p><p></p><p>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. </p><p></p><p>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. </p><p></p><p>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. </p><p></p><p>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. </p><p></p><p>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. </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></p><p></p><p></p><p>AHH, with all the bad news about FDA et al on there lack of enforcement, I would have expected a token mad cow feed ban warning letter or two to pop up now. what would really be interesting would be to see all violations of the mad cow feed ban, large and small, from all states. ...tss</p><p></p><p>#################### <a href="https://lists.aegee.org/bse-l.html" target="_blank">https://lists.aegee.org/bse-l.html</a> ####################</p><p></p><p></p><p>BSE, BOVINE - USA: FEED RECALL</p><p>*******************************</p><p>A ProMED-mail post</p><p><http://www.promedmail.org></p><p>ProMED-mail is a program of the</p><p>International Society for Infectious Diseases</p><p><http://www.isid.org></p><p></p><p>Date: 21 Jun 2006</p><p>From: Terry Singeltary <flounder9@verizon.net></p><p>Source: Chron.com, 20 Jun 2006 [edited]</p><p><http://www.chron.com/disp/story.mpl/ap/fn/3987413.html></p><p></p><p></p><p>Mad Cow Feed Recall, USA, Albertville, AL, 16 Jun 2006; Feed Recalled </p><p>Over Mad Cow Violation</p><p>-----------------------------------------------</p><p>Livestock feed ingredients shipped to 9 states may have been </p><p>contaminated with cattle remains in violation of a 1997 ban to </p><p>protect against mad cow disease, a manufacturer said Tuesday [20 Jun 2006].</p><p></p><p>H.J. Baker & Bro. Inc. said it was recalling 3 livestock feed </p><p>ingredients, including 2 used to supplement feed given to dairy cows. </p><p>A sample tested by the Food and Drug Administration was positive for </p><p>cattle meat and bone meal, said Mark Hohnbaum, president of the </p><p>Westport, Connecticut-based company's feed products group.</p><p></p><p>"This is very concerning to us. This isn't something that happens to </p><p>us. We are very serious about food safety," Hohnbaum said. Mad cow </p><p>disease is only known to spread when cows eat feed containing brain </p><p>and other nerve tissue from infected cattle. Protein from cattle was </p><p>commonly added to cattle feed to speed growth until the ban largely </p><p>outlawed the practice.</p><p></p><p>Cattle tissue may have contaminated 2 feed ingredients given to dairy </p><p>cows -- Pro-Lak and Pro-Amino II -- made by H.J. Baker between August </p><p>2005 and June 2006. The 3rd of the recalled ingredients, Pro-Pak with </p><p>Porcine Meat and Bone, was mislabeled. It is used in poultry feed.</p><p></p><p>The company announced the recall in the wake of ongoing FDA </p><p>inspections of its Albertville, Alabama plant, Hohnbaum said. The </p><p>inspections have found manufacturing and clerical issues, he added.</p><p></p><p>The company shipped the ingredients to feed manufacturers and dairy </p><p>farms in the following states: Alabama, California, Florida, Georgia, </p><p>Kentucky, Louisiana, Michigan, Mississippi and Tennessee. The company </p><p>is notifying its customers of the voluntary recall. It does not know </p><p>how much of the feed ingredients it sold, Hohnbaum said.</p><p></p><p>On the Net:</p><p>Food and Drug Administration animal feed information:</p><p><http://www.fda.gov/cvm/animalfeed.htm></p><p></p><p>--</p><p>Terry S. Singeltary Sr.</p><p><flounder9@verizon.net></p><p></p><p>[The company is already notifying its customers. Furthermore, the </p><p>company does not know how much feed was contaminated, so they are </p><p>likely being very cautious and notifying customers, although they may </p><p>not have had animals exposed.</p><p></p><p>It is likely the company does not know how much contamination each </p><p>batch of feed received.</p><p></p><p>Customers should be forewarned that even if an animal consumes some </p><p>of this feed, it does not mean it is sure to come down with Bovine </p><p>Spongiform Encephalopathy (BSE). It takes a certain amount of </p><p>infective material being consumed as well as certain conditions </p><p>within the animal for BSE to develop.</p><p></p><p>What is intriguing about this event is that, though the FDA will fine </p><p>the feed manufacturer, on-farm mixing of feed that may contain </p><p>prohibited material does not find its way onto the FDA radar screen. </p><p>There have been multiple cases of farm-site feed mixing with </p><p>confirmation of prohibited material being in the feed, and the feed </p><p>being fed to cattle. When this apparent oversight was brought to the </p><p>attention of the FDA, the reply was that they [the FDA] did not </p><p>believe they had jurisdiction over the farm, only the manufacturers. </p><p>Since the FDA could not demonstrate a prion to a court of law, they </p><p>did not see how they could prosecute a case of farm-site feed mixing.</p><p></p><p>Clearly, had the international team that surveyed the situation in </p><p>the US during 2004 known of this approach, their recommendations may </p><p>well have been different.</p><p></p><p>Without adherence to the feeding rules, cases of BSE in the United </p><p>States will likely continue to occur on a sporadic basis. - Mod.TG]</p><p></p><p>[see also:</p><p>2004</p><p>----</p><p>BSE, bovine - USA (WA) (16): new regulations 20040318.0747</p><p>BSE, bovine - USA: APHIS report 20040205.0426</p><p>2003</p><p>----</p><p>BSE, bovine - USA (WA) (09): new regulations 20031230.3172]</p><p>..................tg/msp/mpp</p><p></p><p>*##########################################################*</p><p>************************************************************</p><p>ProMED-mail makes every effort to verify the reports that</p><p>are posted, but the accuracy and completeness of the</p><p>information, and of any statements or opinions based</p><p>thereon, are not guaranteed. The reader assumes all risks in</p><p>using information posted or archived by ProMED-mail. ISID</p><p>and its associated service providers shall not be held</p><p>responsible for errors or omissions or held liable for any</p><p>damages incurred as a result of use or reliance upon posted</p><p>or archived material.</p><p>************************************************************</p><p>Become a ProMED-mail Premium Subscriber at</p><p><http://www.isid.org/ProMEDMail_Premium.shtml></p><p>************************************************************</p><p>Visit ProMED-mail's web site at <http://www.promedmail.org>.</p><p>Send all items for posting to: <a href="mailto:promed@promedmail.org">promed@promedmail.org</a></p><p>(NOT to an individual moderator). If you do not give your</p><p>full name and affiliation, it may not be posted. Send</p><p>commands to subscribe/unsubscribe, get archives, help,</p><p>etc. to: <a href="mailto:majordomo@promedmail.org">majordomo@promedmail.org</a>. For assistance from a</p><p>human being send mail to: <a href="mailto:owner-promed@promedmail.org">owner-promed@promedmail.org</a>.</p><p>############################################################</p><p>############################################################</p></blockquote><p></p>
[QUOTE="flounder, post: 236515, member: 3519"] ##################### Bovine Spongiform Encephalopathy ##################### Subject: Agriculture Secretary Mike Johanns Gaggle regarding Japanese Beef Issues Date: June 27, 2006 at 6:37 pm PST Release No. 0221.06 Contact: Press Office (202)720-4623 Agriculture Secretary Mike Johanns Gaggle regarding Japanese Beef Issues. June 27, 2006 SEC. JOHANNS: The audit teams are here in the United States, and every indication so far is that things are going just fine. I think they've been in three plants if I have my information correct, and as I've said it appears like we're moving along well through the audits, and everything is on track. I haven't been made aware of any significant problems that have developed either in the audits or in the process moving through the audits. I do want to indicate also that I just think the comments from Japan are very encouraging these days, and it's especially encouraging to see the comment that one problem with the shipment would not stop trade, that they would deal with the individual plant. That's a message that we talked about before many, many months now. So I am very encouraged. We're anxious to get through the audits, deal with whatever issues are there. But so far so good. REPORTER: Any further assurances when Mr. Koizumi -- SEC. JOHANNS: I think we're in good shape. I'm not sure if it will come up or not. I certainly have not raised the issue with the President. They've worked together for five years, and I suspect they have a wide range of issues to talk about. But I think so far so good. I think we're doing well, and like I said the audits seem to be going fine. REPORTER: -- right after the agreements (unclear) in their work and that you're not satisfied. Can you elaborate? SEC. JOHANNS: The only point I wanted to make is that the agreement was a step. It was, I didn't want anybody to have the impression that somehow beef was heading back to Japan. We still have some process to get through here. So that's the point I wanted to make. I especially didn't want anyone on the Hill, House or Senate side, to feel like they were being misled that somehow I had reached an agreement and beef was moving back into Japan. It is not. We've got a ways to go yet. REPORTER: Mr. Secretary, if when the audits are complete if they find any problems with individual plants, would you, A, go ahead with trade? Or B, wait until all the plants are approved? SEC. JOHANNS: We faced that issue with Korea as you know, and we believe very, very strongly in our system. And so what we are doing is working through those individual plant issues. And that' what I would intend to do with Japan. Now again I will stress to you, Bill, if we find a plant that is not ready for shipment into Japan, we simply are going to take action on our own to make sure that they are not part of the original group. But that really I see as a United States decision. I don't see that as anything like that. So the point is we see our system as a whole system. This is not about individual pick and choose and we'll take this plant but not that plant. We really want to move this full process all at once. If in the process the United States finds a plant that's problematic and not ready for shipment, we would set them to the side. But I don't think we're going to see that. REPORTER: -- curing the problem, the whole market is shut down because of one plant. SEC. JOHANNS: Well, if the plant is not ready, we'll solve that problem. REPORTER: But how do you deal with it in the future if we have a single or double plant problem, Japanese want to shut down the whole market? SEC. JOHANNS: Well, that becomes a very serious problem. I mean this time we decided it's best to work through it, but my hope is we don't go that way again any more than I would argue we should shut down their whole automobile market because we find a defective car. REPORTER: But they've not agreed to anything? SEC. JOHANNS: Well, the indications are positive. But the indications are that if they are wiling to work with us then that is positive. REPORTER: Are you satisfied with the conditions set by Japan? SEC. JOHANNS: So far so good. I mean we're still working through issues, and so give me some leeway there. But so far so good. I think we're headed toward successful audits and markets reopening. REPORTER: Mr. Secretary, what was your reaction to Canada's imposition of its strict feed rule yesterday? SEC. JOHANNS: I talked to the Minister of Agriculture over the weekend, and he indicated to me that that's where they were headed. And so first thing I would say is, that it was not a surprise. They gave us a heads up and indicated to us why they felt they needed to do this. As you know, they identified some cases of BSE in Canada, and so I guess beyond that my reaction is that it's a decision Canada can make and I was pleased to be forewarned. REPORTER: Mr. Secretary, do you think that the Canadian feed rule is an advantage in exporting to Japan? And has FDA given you any indication of when the U.S. will come out with their revision? SEC. JOHANNS: I don't know when the FDA will come out with a revised approach here. I don't think so. You know, we have found so little BSE in the United States. It's just virtually nonexistent. Plus international standards. I do think the world is moving toward (unclear) international standards, and so I don't think it gives them a particular advantage. REPORTER: Mr. Secretary, for the nonbeef crowd I just wondered if you anticipate following the same model as you followed with Korea, meaning waiting for all U.S. plants except for the example you gave? SEC. JOHANNS: We want all plants approved. REPORTER: So (unclear) the same with Japan? SEC. JOHANNS: Well, I hope we don't face it. But if we do we will work to get all plants approved. Again, if there's a single plant that's not ready for shipment we make that determination here in the United States, that's a different matter. But we see our whole system as a system that approves all plants and that's where we want to -- REPORTER: How would you decide a plant is not ready for shipment? SEC. JOHANNS: Oh, I think there would be some obvious examples. If they just simply don't understand the system, haven't done the training, haven't followed the steps that we put in place, then that's pretty obvious to us that they're not ready for beef shipments to Japan. REPORTER: -- adjust on policy, standards, would that be (unclear) disqualify them? SEC. JOHANNS: I think we'd walk through the specifics here because it gets so hypothetical. But here's my point. My point is that if Japan sees some paperwork issues and the issues have been solved, readily solved, then we want all plants to move together. If on the other hand we say look, we found training deficiencies, we found employees that didn't understand the rules, and this is just not going to work, and we looked at it and said, yeah, they're not ready for shipment to Japan, we're going to let that happen. My belief is that plants that wanted a certain (unclear) be ready. Okay. [url=http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB/.cmd/ad/.ar/sa.retrievecontent/.c/6_2_1UH/.ce/7_2_5JM/.p/5_2_4TQ/.d/2/_th/J_2_9D/_s.7_0_A/7_0_1OB?PC_7_2_5JM_contentid=2006%2F06%2F0221.xml&PC_7_2_5JM_parentnav=TRANSCRIPTS_SPEECHES&PC_7_2_5JM_navid=TRANSCRIPT#7_2_5JM]http://www.usda.gov/wps/portal/!ut/p/_s ... PT#7_2_5JM[/url] Japan would be very very irresponsible to it's consumer to start importing TSE from the USA. ...TSS #################### [url=https://lists.aegee.org/bse-l.html]https://lists.aegee.org/bse-l.html[/url] #################### ##################### Bovine Spongiform Encephalopathy ##################### 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] AHH, with all the bad news about FDA et al on there lack of enforcement, I would have expected a token mad cow feed ban warning letter or two to pop up now. what would really be interesting would be to see all violations of the mad cow feed ban, large and small, from all states. ...tss #################### [url=https://lists.aegee.org/bse-l.html]https://lists.aegee.org/bse-l.html[/url] #################### BSE, BOVINE - USA: FEED RECALL ******************************* A ProMED-mail post <http://www.promedmail.org> ProMED-mail is a program of the International Society for Infectious Diseases <http://www.isid.org> Date: 21 Jun 2006 From: Terry Singeltary <flounder9@verizon.net> Source: Chron.com, 20 Jun 2006 [edited] <http://www.chron.com/disp/story.mpl/ap/fn/3987413.html> Mad Cow Feed Recall, USA, Albertville, AL, 16 Jun 2006; Feed Recalled Over Mad Cow Violation ----------------------------------------------- Livestock feed ingredients shipped to 9 states may have been contaminated with cattle remains in violation of a 1997 ban to protect against mad cow disease, a manufacturer said Tuesday [20 Jun 2006]. H.J. Baker & Bro. Inc. said it was recalling 3 livestock feed ingredients, including 2 used to supplement feed given to dairy cows. A sample tested by the Food and Drug Administration was positive for cattle meat and bone meal, said Mark Hohnbaum, president of the Westport, Connecticut-based company's feed products group. "This is very concerning to us. This isn't something that happens to us. We are very serious about food safety," Hohnbaum said. Mad cow disease is only known to spread when cows eat feed containing brain and other nerve tissue from infected cattle. Protein from cattle was commonly added to cattle feed to speed growth until the ban largely outlawed the practice. Cattle tissue may have contaminated 2 feed ingredients given to dairy cows -- Pro-Lak and Pro-Amino II -- made by H.J. Baker between August 2005 and June 2006. The 3rd of the recalled ingredients, Pro-Pak with Porcine Meat and Bone, was mislabeled. It is used in poultry feed. The company announced the recall in the wake of ongoing FDA inspections of its Albertville, Alabama plant, Hohnbaum said. The inspections have found manufacturing and clerical issues, he added. The company shipped the ingredients to feed manufacturers and dairy farms in the following states: Alabama, California, Florida, Georgia, Kentucky, Louisiana, Michigan, Mississippi and Tennessee. The company is notifying its customers of the voluntary recall. It does not know how much of the feed ingredients it sold, Hohnbaum said. On the Net: Food and Drug Administration animal feed information: <http://www.fda.gov/cvm/animalfeed.htm> -- Terry S. Singeltary Sr. <flounder9@verizon.net> [The company is already notifying its customers. Furthermore, the company does not know how much feed was contaminated, so they are likely being very cautious and notifying customers, although they may not have had animals exposed. It is likely the company does not know how much contamination each batch of feed received. Customers should be forewarned that even if an animal consumes some of this feed, it does not mean it is sure to come down with Bovine Spongiform Encephalopathy (BSE). It takes a certain amount of infective material being consumed as well as certain conditions within the animal for BSE to develop. What is intriguing about this event is that, though the FDA will fine the feed manufacturer, on-farm mixing of feed that may contain prohibited material does not find its way onto the FDA radar screen. There have been multiple cases of farm-site feed mixing with confirmation of prohibited material being in the feed, and the feed being fed to cattle. When this apparent oversight was brought to the attention of the FDA, the reply was that they [the FDA] did not believe they had jurisdiction over the farm, only the manufacturers. Since the FDA could not demonstrate a prion to a court of law, they did not see how they could prosecute a case of farm-site feed mixing. Clearly, had the international team that surveyed the situation in the US during 2004 known of this approach, their recommendations may well have been different. Without adherence to the feeding rules, cases of BSE in the United States will likely continue to occur on a sporadic basis. - Mod.TG] [see also: 2004 ---- BSE, bovine - USA (WA) (16): new regulations 20040318.0747 BSE, bovine - USA: APHIS report 20040205.0426 2003 ---- BSE, bovine - USA (WA) (09): new regulations 20031230.3172] ..................tg/msp/mpp *##########################################################* ************************************************************ ProMED-mail makes every effort to verify the reports that are posted, but the accuracy and completeness of the information, and of any statements or opinions based thereon, are not guaranteed. The reader assumes all risks in using information posted or archived by ProMED-mail. ISID and its associated service providers shall not be held responsible for errors or omissions or held liable for any damages incurred as a result of use or reliance upon posted or archived material. ************************************************************ Become a ProMED-mail Premium Subscriber at <http://www.isid.org/ProMEDMail_Premium.shtml> ************************************************************ Visit ProMED-mail's web site at <http://www.promedmail.org>. Send all items for posting to: [email=promed@promedmail.org]promed@promedmail.org[/email] (NOT to an individual moderator). If you do not give your full name and affiliation, it may not be posted. Send commands to subscribe/unsubscribe, get archives, help, etc. to: [email=majordomo@promedmail.org]majordomo@promedmail.org[/email]. 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