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From: TSS ()
BSE/Ruminant Feed Inspection Checklist (Version 5.0, March 19, 2007) REPORT OF INSPECTION FOR COMPLIANCE WITH 21 CFR §589.2000 F Firm Firm City: _____________________________________________________ Lead Affiliation (ch Federal Firm StateZIP CodePhone #: ________________ State A GPS Coordinates of Inspected Site: _____________________________ FDA District Office: __________ Name and title of person(s) interviewed: ________________________________________________________________________ Name and title of most responsible persote: ________________________________________ Operational Status: (Check only Operati Seasonal Inactive Out of Business ee Instructions) m is S Renderer Feed Mill (FDA Licensed) On-farm Feed Mixer Protein Blender Feed Mill (not FDA Lice Feeder of Ruminants Transporter (Hauler) Pet Food Manufacturer Human Food Processor 2. Doests that contain or may contain prohibited materiM)? (Chck only on YES, but PM is Only in Retail Pet/Lab Feed YES NO ------------------------------------------------------------------------------------------------------------------------------------------------------ If Question 2 is "YES, but PM is only in Retail Pet/Lab Feed" or "NO," check all oluntary safeguards the firm has in place to assure they do not receive prohibited material. Written assurance from suppliers that they no longer manufacture/distribute any products containing pro Written assurance from transporters that they do not transport products containing prohibited materials Written assurance from transporters that they utilize dedicated adequately prevent commingling or cross-contamination Written procedures for the label review of incoming materials Uses animal proteins only from exempted sources (Circle all that apply: blood, milk, "plate waste", porcine, equine, poultry, fish, gelatin) Testing of incoming materials, (please describe) _________________________________________________________ ____________________________________________________________________________ ____________________________________________________________________________ originating in the United States) used? YES NO Unknown 3. Is the received product containing prohibited material intended ONLY for further YES NO 5. Are the received feeds or feed ingredients containing prohibited materials (re attle or other ruminantsCheck only one) StimFirms that are ONLY Q1a) Firm Type = "Other" OR Are the outgoing feeds or feed ingredients contai le or other ruminants"? (Check only one) No Outgoing Feeds/Ingredients containing PM PM is Only in Retail Pet/Lab Feed YES NO 7cribe records the firm maintains in tracking prohibits throutheir re a) Date of receipt or purchase or s YES NO b) Name and address of the seller YES NO c) Name and address of the purc YES NO d) Identificati YES NO e) Quantity YES NO f) Copies are available for inspection and co YES NO g) Are ONLY retail feed sales involved? YES NO Does the firm manufacture, process, blend, repackining proibited materials AN Does the firm manufacture, process, blend, repackage, oining proibited materials AN a) If the answer to Q8a) is "NO," then SKIP to Question 10. If the answer to Q8a) is "YES," check ALL ingling or cross-contam Sequencing of feeds Flushing the system, (please describe) ______ Written sequencing and flushing procedures Documentation maintained of sequencing and flushing Flushed materials discarded or labeled with the ca Physical clean-out (e.g. vacuuming, cleaning) Dedicated equipment used for prohibited materials Product containing prohibited material is always in packaged form when in the firm’s possession Other, (please describe) ____________________________________________________________________________ Please describe any additional safeguards the firm has in place to assure that outgoing feeds or feed ingredients containing prohibited material are not shipp_________________________________________________________ (I StiQ1a) Firm Type = "Other" OR 11. a) Are any incoming feedted in bulk form b) Are any incoming feedted in packaged c) Does the firm utilize its own transportation vehicles for the delivery of any bulk incoming feeds or feed ingredients? e) If 11(d) is "YES," do ALL inbound transporters provide written assurance that they utilize dedicated tran utilisures thontamd material 12. a) Are any outgoing fed in bulk form? b) Are any outgoingted in bagged/packaged form? c)for the delivery of any outgoing buds or feedingredients? d)icles for the delivery of any outgoink feeds or feed ingredients? e) If 12(d) is "YES," do ALL outbound transporters provide written assurance that they utilize dedicated transport equipm OR ing or cross-contamination with prohibited material b) Maintaining copies of labeling for feeds containing a c) Maintaining copies of purchase invoices for feeds co e) Feedohibitedaterial f) S 14. a) Check Commingling Labeling No Deviations Noted Recordkeeping Feeding Ruminants Prohibited Material b) If any deviations were noted above, describe the deviations, and the actions and commitments made to correct each deviation, ____________________________________________________________________________________________________ _____________________________________________________________________________________ INSTRUCTIONS – For the Lead Investigator District BSE Coordinator. The FDA District BSE Coordinator is responsible for communicating and receiving information related to the BSE Checklist/Report. Questions, comments and concerns should be directed to this individual. Completed BSE Reports of Inspection generated by State agencies should be mailed to the District BSE Coordinator, not to CVM. T fo BSE Checklist/Report Version. Please make sure you are using the most current BSE Checklist/Report version. The version date is located at the top of the form. Check with your BSE District Coordinator or the FDA/CVM website (www.fda.gov/cvm/form/forms.html) to make sure you are using the most recent v the BSE Checklist/Report Database and may invalidate the information collected. BSE Checklist/Report Alterations. Some agencies may choose to alter the BSE Checklist/Report to better fit their own operations. While CVM does not necessarily object to such alterations, changes must be added to the end revisions should be made to the main body of the CVM-version of the BSE Checklist/Report. Legibility. Illegible writing results in inaccurate data, which com handwritten checklist, please print your responses to the questions. Completing Sections. Sections should be fully completed for each of the firm types indicated in the header of each Section. Sections inappropriately skipped (based on the firm type) may cause the BSE Checklist/Report to be considered incomplete. I Reports of Inspection may require follow-up with the investigator and may require a follow-up inspection at the firm. Completing Questions. The BSE Checklist/Report instructions and flow of questions must be followed. Blank or unanswered required questions may cause the BSE Checklist/Report to be considered incomplete. Inc require a follow-up with the investigator and may require a follow-up inspection of the firm. Descriptive Fields. For those questions that ask for an explanation or description, please be brief and capture the essential elements with as few words as possible. If you feel certain answers require a more lengthy description, consider recording the information on a separate page, which should be attached to asks if additional documents are attached. Additional Narrative. For those state BSE/Ruminant Feed inspections not being done under federal contract or those state contract BSE/Ruminant Feed inspections that do not include an FDA-481, it is recommended that a brief narrative report accompany the BSE Checklist/Report summarizing the c CHECKLIST QUES Firm information – Complete for ALL firms, regardless of the firm type. FEI Number. The FEI number is absolutely required. It is the District’s responsibility to provide this information, and you may need to contact your District BSE Coordinator for this information. The District may need to assign an FEI number after the inspection is completed. For example, if the firm has not been inspected before, the District will assign an FEI number when it receives th Firm Name. Use the firm’s accurate legal name. Do not use "Doing Business As" (DBA) firm names if at all possible. Firm Address. The address should reflect the physical location of the firm’s activities. Post Office Box nu If the firm’s mailing address is different than their physical address, please make a note of this information. Date Current Inspection Ended. If the inspection went more th Lead Investigator. Enter the name of the lead investigator. Lead Affiliation. If the i in the name of the State. FDA District Office. Enter the name of the FDA District in which the ins GPS Coordinates. This information is not required by FDA at this time. Name and title of the person(s) interviewed. Record the name and title of the person(s) interviewed during the inspection. Name and title of most responsible person at the site. Record the name and title of the most responsible pers example the firm’s President or Manager. This may or may not be the person interviewed during the inspection. Operational Status. Mark the firm’s operational status. Inspection reports should be completed for Seaso Changes to firm name and address. If the facility/site has a new name and/or address, please check the box indicating this and make sure the address re yo Section 1 -- Complete for ALL firms, regardless of the firm type (with the exception of firms which are Out of Business). Question 1a) Firm Type. Please understand the firm il is provided in Co Substances intended solely for other purposes (e.g. fertilizers) are not included in this category. Question 1— b) Further defines "handling" for better clarification. c) Is new animals. d) Is new and asks whether the firm is aware of the BSE rule or not. Question 2 – Has been changed slightly. If you answer "NO" or "YES, but PM is only in Retail Pet/Lab feed" then go through the list of boxes in 2a) to describe the safeguards the firm is taking to make sure they do not receive prohibited material for use in their manufacturing operation. If the answer to Q2) is "no", or if the firm is only a "feeder of ruminants", then do not complete question #2b) and skip to Section 3, Questio country of origin of that product. Question 3 – Is the received product that contains prohibited material being held only for further distribution? Mark "Yes" or "No". Question 4 – Is the firm manufacturing, or otherwise processing, products that contain prohib Note – The answers to questions Q3) and Q4) can both be "No", but they cannot both be "Yes". Question 5 – Are feeds containing prohibited material properly labeled with the caution statement? Raw animal products destined for a renderer are not required to be labeled. If you are inspecting someone supplying/transporting raw animal products to a renderer, mark "PM is only for rendering". Retail pe unless the prod Section 2 – If the firm "handles" (manufacture contain prohibited material, complete section 2. Question 6 – Asks if outgoing feeds that contai The first option, "No Outgoing Feeds/Ingredients containing PM", for example, may be used when inspecting a farm that mixes its own feed. The second box, "PM is ONLY in Retail Pet/Lab Feeds" is to be used in those cases where the only prohibited material on the premises is found in pet or lab animal feed. Question 7 –The purpose of the question is for the Investigator/Inspector to simply note the types of recordkeeping being utilized and not to indicate their adequacy with respect to the BSE/Ruminant Feed Regulation (21 CFR 589.2000). Re should be indicated and described in Section 5. Retail sales are sales made to the ultimate consumer – people purchasing feed for their animals. g) Mark "yes" if the firm sells feed (any kind of feed, including pet food) but does not manufacture feed at the site. h) If you marked "yes" on g) and the only type of feed sold at the firm is pet food, mark "yes" on h) as well. Question 8 – Commingling and blending, repackaging or transporting a product. a) Asks if the firm makes a feed product containing prohibited material AND a feed product which does not contain any prohibited material. b) Asks if the firm makes a feed product containing prohibited material AND a feed product for ruminants. Question 9 – If the answer to 8a) is "NO", ski measures the firm has adopted to avoid commingling and cross-contamination. Use the narrative fields if necessary. One additional option has been added to the list that was in the last version of the checklist – "Product containing prohibited material is always in packaged form when in the firm’s possession". Q contain prohibited material from being shipped to ruminant feeders. Section 3 – This section is new, and deals with the transportation of feeds and feed ingredients in and out of manufacturing facilities and feeding operations, including feed mills, ingredient manufacturers, and ruminant feeders. intended to be used during the inspection of firms engaged only in transportation. Transportation equipment is treated like mixing equipment, for example, and when inspecting a transportation firm you would ask the same questions about recordkeeping and cleanout asked of feed mills, renderers and other facilities that may handle prohibited material. Question 11 – Deals with the transport of feeds and ingredients into the firm. On 11 e) only answer "yes" if EVERY inbound transporter provides written assurance that they use dedicated equipment or have adequate cleanout procedures, otherwise the answer is "no". Qtr is "no". Section 4. This section is to be used only when the firm feeds ruminant animals. Question 13 – Contains six questions to be answered when inspecting a ruminant feeder. a) Mark "No PM-feeds on premises" only if you found NO feed on the premises containing prohibited material, not including retail pet food intended for cats and dogs. b) Mark "No AP-feeds on premises" only if you found NO feed on the premises containing animal protein, not including retail pet food intended for cats and dogs. c) Mark "No AP-feeds on premises" only if you found NO feed on the premises pr"Y including retail pet food intended for cats and dogs. f) Does the firm have pet cats and/or dogs? Please answer. Section 5. This section should be completed for all firms, unless the firm was found to be Out of Business (OOB). Question 14 – a) Mark the boxes for any deviations of 21 CF describe any deviations identified, and to record action taken, or commitments made, by the firm in response. Issues related to 21 CFR 589.2000 may be noted for firms that are not handling prohibited material. An example would be the use of the caution statement when the firm is not handling p Q INSTRUCTIONS – For the District BSE Coordinator to the success of BSE compliance efforts. The District BSE Coordinator should pay particular attention to eri mpanying instructions are distributed and utilized. . All questions within a required section are completed. ided. • Response inconsistencies are resolved. M. he Districts are responsible for checking the forms for completeness and accuracy, and for entering the information into FACTS. e appropriate District. The following individuals are additional contacts: gov v 301-827-5652 (Version 5.0, 03/19/2007; FDA/CVM, HFV-230, www.fda.gov/cvm/Documents/BSE_V50.doc) The District BSE Coordinator has a key role and overall responsibility for ensuring that BSE Reports of Inspection are completed fully and accurately, which is vital All completed BSE Reports of Inspection generated by State agencies should be sent to the District BSE Coordinator, not to CV T Any questions, concerns or comments regarding the BSE Checklist/Report or the BSE/Ruminant Feed Inspection Compliance Program should be directed to the BSE Coordinator in th BSE/Ruminant Feed Inspection Compliance Program CVM: Shannon Jordre shannon.jordre@fda.hhs. 240-276-9229 ORA: Jim Dunnie james.dunnie@fda.hhs.go maybe it will be revised as to not allow the continued feeding of tainted and prohibited MBM 10+ MILLION POUNDS INTO COMMERCE AND BEING FED OUT IN 2007. ... Date: March 21, 2007 at 2:27 pm PST ___________________________________ END OF ENFORCEMENT REPORT FOR MARCH 21, 2007 PRODUCT RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II ______________________________ ______________________________ ______________________________ ______________________________ ______________________________ ______________________________ END OF ENFORCEMENT REPORT FOR AUGUST 9, 2006 ### ### ### ### END OF ENFORCEMENT REPORT FOR July 12, 2006 ### New Orleans District Telephone: 615-781-5380 WARNING LETTER NO. 2006-NOL-06 FEDERAL EXPRESS Mr. William Shirley, Jr., Owner Dear Mr. Shirley: On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration Our investigation found you failed to provide measures, including sufficient You failed to use clean-out procedures or other means adequate to prevent You failed to maintain written procedures specifying the clean-out As a result . the poultry meal you manufacture may contain protein derived This letter is not intended as an all-inclusive list of violations at your You should notify this office in writing within 15 working days of receiving Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S. Sincerely, /S Carol S. Sanchez FULL TEXT ; Suppressed peer review of Harvard study October 31, 2002. http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf THE SEVEN SCIENTIST REPORT *** http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf SEROLOGICALS CORPORATION http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdf Embassy of Japan Dockets Entered on December 22, 2005 03-025IFA 03-025IFA-6 Jason Frost [PDF] http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-589.pdf http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0701&L=sanet-mg&T=0&P=8374 http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0611&L=sanet-mg&T=0&P=3381 Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION] http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt 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 PART 2 FOR IMMEDIATE RELEASE Note: On Dec. 23, 2003, the U.S. Department of Agriculture reported that a cow in Washington state had tested positive for bovine spongiform encephalopathy (BSE, or mad cow disease). As a result, information on this Web page stating that no BSE cases had been found in the United States is now incorrect. However, because other information on this page continues to have value, the page will remain available for viewing. FDA ANNOUNCES TEST RESULTS FROM TEXAS FEED LOT FDA has determined that each animal could have consumed, at most and in total, five-and-one-half grams - approximately a quarter ounce -- of prohibited material. These animals weigh approximately 600 pounds. It is important to note that the prohibited material was domestic in origin (therefore not likely to contain infected material because there is no evidence of BSE in U.S. cattle), fed at a very low level, and fed only once. The potential risk of BSE to such cattle is therefore exceedingly low, even if the feed were contaminated. According to Dr. Bernard Schwetz, FDA's Acting Principal Deputy Commissioner, "The challenge to regulators and industry is to keep this disease out of the United States. One important defense is to prohibit the use of any ruminant animal materials in feed for other ruminant animals. Combined with other steps, like U.S. Department of Agriculture's (USDA) ban on the importation of live ruminant animals from affected countries, these steps represent a series of protections, to keep American cattle free of BSE." Despite this negligible risk, Purina Mills, Inc., is nonetheless announcing that it is voluntarily purchasing all 1,222 of the animals held in Texas and mistakenly fed the animal feed containing the prohibited material. Therefore, meat from those animals will not enter the human food supply. FDA believes any cattle that did not consume feed containing the prohibited material are unaffected by this incident, and should be handled in the beef supply clearance process as usual. FDA believes that Purina Mills has behaved responsibly by first reporting the human error that resulted in the misformulation of the animal feed supplement and then by working closely with State and Federal authorities. This episode indicates that the multi-layered safeguard system put into place is essential for protecting the food supply and that continued vigilance needs to be taken, by all concerned, to ensure these rules are followed routinely. FDA will continue working with USDA as well as State and local officials to ensure that companies and individuals comply with all laws and regulations designed to protect the U.S. food supply. WE know now, and we knew decades ago, that 5.5 grams of suspect feed in TEXAS was enough to kill 100 cows. THE FDA RUMINANT TO RUMINANT FEED BAN OF 8/4/97 WAS NOTHING MORE THAN A PIECE OF PAPER, nothing else. look at the table and you'll see that as little as 1 mg (or 0.001 gm) caused 7% (1 of 14) of the cows to come down with BSE; Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog, Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe Deslys 100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg Primate (oral route)* 1/2 (50%) Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%) 1/15 (7%) RIII mice (icip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%) PrPres biochemical detection The comparison is made on the basis of calibration of the bovine inoculum used in our study with primates against a bovine brain inoculum with a similar PrPres concentration that was inoculated into mice and cattle.8 *Data are number of animals positive/number of animals surviving at the time of clinical onset of disease in the first positive animal (%). The accuracy of bioassays is generally judged to be about plus or minus 1 log. icip=intracerebral and intraperitoneal. Table 1: Comparison of transmission rates in primates and cattle infected orally with similar BSE brain inocula http://www.thelancet.com/journal/journal.isa It is clear that the designing scientists must also have shared Mr Bradley’s surprise at the results because all the dose levels right down to 1 gram triggered infection. 6. It also appears to me that Mr Bradley’s answer (that it would take less than say 100 grams) was probably given with the benefit of hindsight; particularly if one considers that later in the same answer Mr Bradley expresses his surprise that it could take as little of 1 gram of brain to cause BSE by the oral route within the same species. This information did not become available until the "attack rate" experiment had been completed in 1995/96. This was a titration experiment designed to ascertain the infective dose. A range of dosages was used to ensure that the actual result was within both a lower and an upper limit within the study and the designing scientists would not have expected all the dose levels to trigger infection. The dose ranges chosen by the most informed scientists at that time ranged from 1 gram to three times one hundred grams. It is clear that the designing scientists must have also shared Mr Bradley’s surprise at the results because all the dose levels right down to 1 gram triggered infection. To cattle: 1 gram of infected brain material (by oral ingestion) http://www.inspection.gc.ca/english/sci/bio/bseesbe.shtml October 11, 2005 http://www.gao.gov/cgi-bin/getrpt?GAO-06-157R 03-025IFA From: Terry S. Singeltary Sr. [flounder9@verizon.net] Sent: Thursday, September 08, 2005 6:17 PM To: fsis.regulationscomments@fsis.usda.gov Subject: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Disabled Cattle Greetings FSIS, I would kindly like to submit the following to [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Disabled Cattle THE BSE/TSE SUB CLINICAL Non-Ambulatory Disabled Cattle Broken bones and such may be the first signs of a sub clinical BSE/TSE Non-Ambulatory Disabled Cattle ; snip...FULL TEXT ; STRICTLY PRIVATE AND CONFIDENTIAL 25, AUGUST 1995 snip... To minimise the risk of farmers' claims for compensation from feed To minimise the potential damage to compound feed markets through adverse publicity. To maximise freedom of action for feed compounders, notably by snip... THE FUTURE 4.......... MAFF remains under pressure in Brussels and is not skilled at 5. Tests _may_ show that ruminant feeds have been sold which 6. The threat remains real and it will be some years before feed SEE full text ; http://www.bseinquiry.gov.uk/files/yb/1995/08/24002001.pdf A failed policy by a failed and corrupt administration. TSS
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