Subject: BSE/Ruminant Feed Inspection Checklist (Version 5.0, March 19, 2007)
Date: April 12, 2007 at 8:03 am PST
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
ape of firm inspected apply)
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
Does the firm handle (manufactur tingrediens that ar
the feeding of ruminant animals? YES NO Does the firm handle (manufacture, pr tingrediens that ar
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 only vegetable source proteins and uses no ani
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) _________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
If Question 2 is either "YES, but PM is orted pribited mterial (not
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
YES NO
c) Does the firm utilize its own transportation vehicles for the delivery of any bulk incoming feeds or feed ingredients?
Does the firm utilize other firms' 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?
No Outgoing Feeds/Ingredient
b) Are any outgoingted in bagged/packaged form?
No Outgoing Feeds/Ingredients YES NO
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
Are ruminant feeders doing the following?
a) Observing the caution statement on feeds containing prohibited material ( YES NO No PM-feeds on premises
b) Maintaining copies of labeling for feeds containing a
(Not including retail pet food for cats and dogs)
c) Maintaining copies of purchase invoices for feeds co
(Not including retail pet food for cats and dogs)
d) Feeding non-ruminant species (Not including cats and dogs) YES NO
e) Feedohibitedaterial
YES NO
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 (http://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
Considerations:
• A single firm can be categorized as one or more firm types, so mark all firm types that are appropriate. The BSE Checklist/Report may not fully describe the activities
your BSE District Coordinator if additional guidance is needed.
• Warehouse operations should be marked as Distributor/Retailer. Feed mills should be described on the basis of FDA licensure and NOT on whether t
single firm cannot be marked as both a licensed feed mill and an unl
• Ingredient manufacturers are considered unlicensed feed mills. Ruminant feeders (e.g. dairy farms, feedlots) might also be On-farm Mixers, but On-farm Mixers might not be ruminant feeders (e.g. swine farms). The "Feeder of Ruminants and Other Species" category has been deleted in this version of the inspection report form. If doing an inspection at a farm that does
livestock, check the "Other" box and write-in "non-ruminant feeder". On-farm Mixing applies to mixing that is not performed for the purpose of commercial distribution. Generally the use of on-farm mixed feeds occurs on the same farm premises where the feed is made. However, in some cases feeds mixed on-farm are utilized off-premises and/or outside the direct supervision of the farm manager (e.g., a farm
delivered for feeding at physically different farm locations, perhaps under a contract arrangement). On-farm Mixers are su
commercial feed mills. The "Human Food Processor" categor
manufactures human food, mark this box. The "Other" category should be used only for firm operations that are not described by the other categories listed. Improp
use of the "Other" category may cause inaccurate and/or inadequate information to be collected in the remaining Sections. Feed or Feed Ingredients. These are products intended to be fed to animals or used to
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, http://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
nsung the following:
• Familiarity with the Instructions for the Lead Investigator.
• The most recent version of the BSE Checklist/Report and acco
• The BSE Checklist/Report has not been unacceptably altered.
• All required sections are completed
• Handwritten forms are legible.
• The FEI number is provided
• The FDA District Office identity is prov
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
[email protected].
240-276-9229
ORA: Jim Dunnie
[email protected]
http://www.fda.gov/cvm/default.html
HOLY MAD COW, nothing like closing the barn door after all the mad cows got loose.
maybe it will be revised as to not allow the continued feeding of tainted and prohibited
MBM too, like 10+ MILLION POUNDS INTO COMMERCE AND BEING FED OUT IN 2007. ...tss
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. MBM IN COMMERCE USA 2007
Date: March 21, 2007 at 2:27 pm PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II
___________________________________
PRODUCT
Bulk cattle feed made with recalled Darling's 85% Blood Meal, Flash Dried, Recall # V-024-2007
CODE
Cattle feed delivered between 01/12/2007 and 01/26/2007
RECALLING FIRM/MANUFACTURER
Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007. Firm initiated recall is ongoing.
REASON
Blood meal used to make cattle feed was recalled because it was cross-contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment and labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
42,090 lbs.
DISTRIBUTION
WI
___________________________________
PRODUCT
Custom dairy premix products: MNM ALL PURPOSE Pellet, HILLSIDE/CDL Prot-Buffer Meal, LEE, M.-CLOSE UP PX Pellet, HIGH DESERT/ GHC LACT Meal, TATARKA, M CUST PROT Meal, SUNRIDGE/CDL PROTEIN Blend, LOURENZO, K PVM DAIRY Meal, DOUBLE B DAIRY/GHC LAC Mineral, WEST PIONT/GHC CLOSEUP Mineral, WEST POINT/GHC LACT Meal, JENKS, J/COMPASS PROTEIN Meal, COPPINI – 8# SPECIAL DAIRY Mix, GULICK, L-LACT Meal (Bulk), TRIPLE J – PROTEIN/LACTATION, ROCK CREEK/GHC MILK Mineral, BETTENCOURT/GHC S.SIDE MK-MN, BETTENCOURT #1/GHC MILK MINR, V&C DAIRY/GHC LACT Meal, VEENSTRA, F/GHC LACT Meal, SMUTNY, A-BYPASS ML W/SMARTA, Recall # V-025-2007
CODE
The firm does not utilize a code - only shipping documentation with commodity and weights identified.
RECALLING FIRM/MANUFACTURER
Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm initiated recall is complete.
REASON
Products manufactured from bulk feed containing blood meal that was cross contaminated with prohibited meat and bone meal and the labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
9,997,976 lbs.
DISTRIBUTION
ID and NV
END OF ENFORCEMENT REPORT FOR MARCH 21, 2007
http://www.fda.gov/bbs/topics/enforce/2 ... 00996.html
2006 (partial list of) highly potential mad cow protein in commerce 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
http://www.fda.gov/bbs/topics/enforce/2 ... 00968.html
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
###
http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00964.html
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
###
http://www.fda.gov/bbs/topics/enforce/2 ... 00963.html
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
###
http://www.fda.gov/bbs/topics/enforce/2 ... 00963.html
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
###
http://www.fda.gov/bbs/topics/enforce/2 ... 00963.html
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
###
http://www.fda.gov/bbs/topics/enforce/2 ... 00960.html
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
http://www.fda.gov/foi/warning_letters/g5883d.htm
FULL TEXT ;
http://lists.ifas.ufl.edu/cgi-bin/wa.ex ... D=0&P=3854
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
Spongiform Encephalopathy (BSE)
http://www.fsis.usda.gov/OPPDE/Comments ... 0011-1.pdf
[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 9/13/2005
http://www.fsis.usda.gov/OPPDE/Comments ... 5IFA-2.pdf
THE SEVEN SCIENTIST REPORT ***
http://www.fda.gov/ohrms/dockets/docket ... tach-1.pdf
PAUL BROWN M.D.
http://www.fda.gov/ohrms/dockets/docket ... -vol40.pdf
9 December 2005
Division of Dockets Management (RFA-305)
SEROLOGICALS CORPORATION
James J. Kramer, Ph.D.
Vice President, Corporate Operations
http://www.fda.gov/ohrms/dockets/docket ... -vol35.pdf
Embassy of Japan
http://www.fda.gov/ohrms/dockets/docket ... -EC240.htm
Dockets Entered on December 22, 2005
2005D-0330, Guidance for Industry and FDA Review Staff on Collection of
Platelets
by Automated ... EC 203, McDonald's Restaurants Corporation, Vol #:, 34 ...
http://www.fda.gov/ohrms/dockets/dailys ... 122205.htm
03-025IF 03-025IF-631 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-631 Linda A. Detwiler Page 2. Page 3. Page 4.
Page 5. Page 6. Page 7. Page 8. Page 9. Page 10. Page 11. Page 12.
http://www.fsis.usda.gov/OPPDE/Comments ... IF-631.pdf
03-025IF 03-025IF-634 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-634 Linda A. Detwiler Page 2.
Page 3. Page 4. Page 5. Page 6. Page 7. Page 8.
http://www.fsis.usda.gov/OPPDE/Comments ... IF-634.pdf
Page 1 of 17 9/13/2005 [PDF]
... 2005 6:17 PM To: [email protected] Subject: [Docket
No. 03-025IFA]
FSIS Prohibition of the Use of Specified Risk Materials for Human Food ...
http://www.fsis.usda.gov/OPPDE/Comments ... 5IFA-2.pdf
03-025IFA 03-025IFA-6 Jason Frost [PDF]
... Zealand Embassy COMMENTS ON FEDERAL REGISTER 9 CFR Parts 309 et al
[Docket No. 03-
025IF] Prohibition of the Use of Specified Risk Materials for Human Food and
...
http://www.fsis.usda.gov/OPPDE/Comments ... 5IFA-6.pdf
In its opinion of 7-8 December 2000 (EC 2000), the SSC ... [PDF]
Page 1. Linda A. Detwiler, DVM 225 Hwy 35 Red Bank, New Jersey 07701 Phone:
732-741-2290
Cell: 732-580-9391 Fax: 732-741-7751 June 22, 2005 FSIS Docket Clerk US ...
http://www.fsis.usda.gov/OPPDE/Comments ... IF-589.pdf
3. Mad Cow Disease: FDA's Management of the Feed Ban Has Improved,
but Oversight Weaknesses Continue to Limit Program Effectiveness.
GAO-05-101, Feb. 25.
http://www.gao.gov/cgi-bin/getrpt?GAO-05-101
Highlights - http://www.gao.gov/highlights/d05101high.pdf
BSE; MRR; IMPORTATION OF LIVE BOVINES AND PRODUCTS
DERIVED FROM BOVINES [Docket No. APHIS-2006-0041] RIN 0579-AC01
FULL TEXT URL @
http://lists.ifas.ufl.edu/cgi-bin/wa.ex ... T=0&P=8374
http://lists.ifas.ufl.edu/cgi-bin/wa.ex ... T=0&P=3381
Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION]
http://www.fda.gov/ohrms/dockets/docket ... 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
http://www.fda.gov/ohrms/dockets/dailys ... 4be07.html
PART 2
http://www.fda.gov/ohrms/dockets/dailys ... 4be09.html
FOR IMMEDIATE RELEASE
P01-05
January 30, 2001
Print Media: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
--------------------------------------------------------------------------------
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
Today the Food and Drug Administration announced the results of tests taken on feed used at a Texas feedlot that was suspected of containing meat and bone meal from other domestic cattle -- a violation of FDA's 1997 prohibition on using ruminant material in feed for other ruminants. Results indicate that a very low level of prohibited material was found in the feed fed to cattle.
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.
http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html
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;
Risk of oral infection with bovine spongiform encephalopathy agent in primates
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
Summary The uncertain extent of human exposure to bovine spongiform encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease (vCJD)--is compounded by incomplete knowledge about the efficiency of oral infection and the magnitude of any bovine-to-human biological barrier to transmission. We therefore investigated oral transmission of BSE to non-human primates. We gave two macaques a 5 g oral dose of brain homogenate from a BSE-infected cow. One macaque developed vCJD-like neurological disease 60 months after exposure, whereas the other remained free of disease at 76 months. On the basis of these findings and data from other studies, we made a preliminary estimate of the food exposure risk for man, which provides additional assurance that existing public health measures can prevent transmission of BSE to man.
snip...
BSE bovine brain inoculum
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
Published online January 27, 2005
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.
http://www.bseinquiry.gov.uk/files/ws/s145d.pdf
2
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.
http://www.bseinquiry.gov.uk/files/ws/s147f.pdf
2) Infectious dose:
To cattle: 1 gram of infected brain material (by oral ingestion)
http://www.inspection.gc.ca/english/sci ... esbe.shtml
SADLY, DEC 2005 SHOWS THAT WE STILL HAVE A SERIOUS PROBLEM WITH BSE/TSE MAD COW DISEASE FEED
GAO
GAO-06-157R FDA Feed Testing Program
October 11, 2005
SNIP...FULL TEXT 29 PAGES ;
http://www.gao.gov/new.items/d06157r.pdf
Mad Cow Disease: An Evaluation of a Small Feed Testing Program FDA Implemented in 2003 With Recommendations for Making the Program a Better Oversight Tool. GAO-06-157R, October 11
http://www.gao.gov/cgi-bin/getrpt?GAO-06-157R
CVM Update
November 2005 Update on Feed Enforcement Activities to Limit the Spread of BSE
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
http://www.fda.gov/cvm/5580.htm
[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
Terry S. Singeltary
Page 1 of 17
From: Terry S. Singeltary Sr. [[email protected]]
Sent: Thursday, September 08, 2005 6:17 PM
To: [email protected]
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 ;
http://www.fsis.usda.gov/OPPDE/Comments ... 5IFA-2.pdf
AND WHOM HAVE THE FEEDERS PROTECTED IN THE PAST FROM MAD COW DISEASE AND WHAT WAS THERE MAJOR CONCERNS $
STRICTLY PRIVATE AND CONFIDENTIAL 25, AUGUST 1995
snip...
To minimise the risk of farmers' claims for compensation from feed
compounders.
To minimise the potential damage to compound feed markets through adverse publicity.
To maximise freedom of action for feed compounders, notably by
maintaining the availability of meat and bone meal as a raw
material in animal feeds, and ensuring time is available to make any
changes which may be required.
snip...
THE FUTURE
4..........
MAFF remains under pressure in Brussels and is not skilled at
handling potentially explosive issues.
5. Tests _may_ show that ruminant feeds have been sold which
contain illegal traces of ruminant protein. More likely, a few positive
test results will turn up but proof that a particular feed mill knowingly
supplied it to a particular farm will be difficult if not impossible.
6. The threat remains real and it will be some years before feed
compounders are free of it. The longer we can avoid any direct
linkage between feed milling _practices_ and actual BSE cases,
the more likely it is that serious damage can be avoided. ...
SEE full text ;
http://www.bseinquiry.gov.uk/files/yb/1 ... 002001.pdf
A failed policy by a failed and corrupt administration.
THIS is what happens when you have the industry run the government.
TSS
Date: April 12, 2007 at 8:03 am PST
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
ape of firm inspected apply)
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
Does the firm handle (manufactur tingrediens that ar
the feeding of ruminant animals? YES NO Does the firm handle (manufacture, pr tingrediens that ar
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 only vegetable source proteins and uses no ani
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) _________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
If Question 2 is either "YES, but PM is orted pribited mterial (not
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
YES NO
c) Does the firm utilize its own transportation vehicles for the delivery of any bulk incoming feeds or feed ingredients?
Does the firm utilize other firms' 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?
No Outgoing Feeds/Ingredient
b) Are any outgoingted in bagged/packaged form?
No Outgoing Feeds/Ingredients YES NO
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
Are ruminant feeders doing the following?
a) Observing the caution statement on feeds containing prohibited material ( YES NO No PM-feeds on premises
b) Maintaining copies of labeling for feeds containing a
(Not including retail pet food for cats and dogs)
c) Maintaining copies of purchase invoices for feeds co
(Not including retail pet food for cats and dogs)
d) Feeding non-ruminant species (Not including cats and dogs) YES NO
e) Feedohibitedaterial
YES NO
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 (http://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
Considerations:
• A single firm can be categorized as one or more firm types, so mark all firm types that are appropriate. The BSE Checklist/Report may not fully describe the activities
your BSE District Coordinator if additional guidance is needed.
• Warehouse operations should be marked as Distributor/Retailer. Feed mills should be described on the basis of FDA licensure and NOT on whether t
single firm cannot be marked as both a licensed feed mill and an unl
• Ingredient manufacturers are considered unlicensed feed mills. Ruminant feeders (e.g. dairy farms, feedlots) might also be On-farm Mixers, but On-farm Mixers might not be ruminant feeders (e.g. swine farms). The "Feeder of Ruminants and Other Species" category has been deleted in this version of the inspection report form. If doing an inspection at a farm that does
livestock, check the "Other" box and write-in "non-ruminant feeder". On-farm Mixing applies to mixing that is not performed for the purpose of commercial distribution. Generally the use of on-farm mixed feeds occurs on the same farm premises where the feed is made. However, in some cases feeds mixed on-farm are utilized off-premises and/or outside the direct supervision of the farm manager (e.g., a farm
delivered for feeding at physically different farm locations, perhaps under a contract arrangement). On-farm Mixers are su
commercial feed mills. The "Human Food Processor" categor
manufactures human food, mark this box. The "Other" category should be used only for firm operations that are not described by the other categories listed. Improp
use of the "Other" category may cause inaccurate and/or inadequate information to be collected in the remaining Sections. Feed or Feed Ingredients. These are products intended to be fed to animals or used to
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, http://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
nsung the following:
• Familiarity with the Instructions for the Lead Investigator.
• The most recent version of the BSE Checklist/Report and acco
• The BSE Checklist/Report has not been unacceptably altered.
• All required sections are completed
• Handwritten forms are legible.
• The FEI number is provided
• The FDA District Office identity is prov
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
[email protected].
240-276-9229
ORA: Jim Dunnie
[email protected]
http://www.fda.gov/cvm/default.html
HOLY MAD COW, nothing like closing the barn door after all the mad cows got loose.
maybe it will be revised as to not allow the continued feeding of tainted and prohibited
MBM too, like 10+ MILLION POUNDS INTO COMMERCE AND BEING FED OUT IN 2007. ...tss
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. MBM IN COMMERCE USA 2007
Date: March 21, 2007 at 2:27 pm PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II
___________________________________
PRODUCT
Bulk cattle feed made with recalled Darling's 85% Blood Meal, Flash Dried, Recall # V-024-2007
CODE
Cattle feed delivered between 01/12/2007 and 01/26/2007
RECALLING FIRM/MANUFACTURER
Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007. Firm initiated recall is ongoing.
REASON
Blood meal used to make cattle feed was recalled because it was cross-contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment and labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
42,090 lbs.
DISTRIBUTION
WI
___________________________________
PRODUCT
Custom dairy premix products: MNM ALL PURPOSE Pellet, HILLSIDE/CDL Prot-Buffer Meal, LEE, M.-CLOSE UP PX Pellet, HIGH DESERT/ GHC LACT Meal, TATARKA, M CUST PROT Meal, SUNRIDGE/CDL PROTEIN Blend, LOURENZO, K PVM DAIRY Meal, DOUBLE B DAIRY/GHC LAC Mineral, WEST PIONT/GHC CLOSEUP Mineral, WEST POINT/GHC LACT Meal, JENKS, J/COMPASS PROTEIN Meal, COPPINI – 8# SPECIAL DAIRY Mix, GULICK, L-LACT Meal (Bulk), TRIPLE J – PROTEIN/LACTATION, ROCK CREEK/GHC MILK Mineral, BETTENCOURT/GHC S.SIDE MK-MN, BETTENCOURT #1/GHC MILK MINR, V&C DAIRY/GHC LACT Meal, VEENSTRA, F/GHC LACT Meal, SMUTNY, A-BYPASS ML W/SMARTA, Recall # V-025-2007
CODE
The firm does not utilize a code - only shipping documentation with commodity and weights identified.
RECALLING FIRM/MANUFACTURER
Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm initiated recall is complete.
REASON
Products manufactured from bulk feed containing blood meal that was cross contaminated with prohibited meat and bone meal and the labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
9,997,976 lbs.
DISTRIBUTION
ID and NV
END OF ENFORCEMENT REPORT FOR MARCH 21, 2007
http://www.fda.gov/bbs/topics/enforce/2 ... 00996.html
2006 (partial list of) highly potential mad cow protein in commerce 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
http://www.fda.gov/bbs/topics/enforce/2 ... 00968.html
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
###
http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00964.html
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
###
http://www.fda.gov/bbs/topics/enforce/2 ... 00963.html
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
###
http://www.fda.gov/bbs/topics/enforce/2 ... 00963.html
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
###
http://www.fda.gov/bbs/topics/enforce/2 ... 00963.html
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
###
http://www.fda.gov/bbs/topics/enforce/2 ... 00960.html
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
http://www.fda.gov/foi/warning_letters/g5883d.htm
FULL TEXT ;
http://lists.ifas.ufl.edu/cgi-bin/wa.ex ... D=0&P=3854
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
Spongiform Encephalopathy (BSE)
http://www.fsis.usda.gov/OPPDE/Comments ... 0011-1.pdf
[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 9/13/2005
http://www.fsis.usda.gov/OPPDE/Comments ... 5IFA-2.pdf
THE SEVEN SCIENTIST REPORT ***
http://www.fda.gov/ohrms/dockets/docket ... tach-1.pdf
PAUL BROWN M.D.
http://www.fda.gov/ohrms/dockets/docket ... -vol40.pdf
9 December 2005
Division of Dockets Management (RFA-305)
SEROLOGICALS CORPORATION
James J. Kramer, Ph.D.
Vice President, Corporate Operations
http://www.fda.gov/ohrms/dockets/docket ... -vol35.pdf
Embassy of Japan
http://www.fda.gov/ohrms/dockets/docket ... -EC240.htm
Dockets Entered on December 22, 2005
2005D-0330, Guidance for Industry and FDA Review Staff on Collection of
Platelets
by Automated ... EC 203, McDonald's Restaurants Corporation, Vol #:, 34 ...
http://www.fda.gov/ohrms/dockets/dailys ... 122205.htm
03-025IF 03-025IF-631 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-631 Linda A. Detwiler Page 2. Page 3. Page 4.
Page 5. Page 6. Page 7. Page 8. Page 9. Page 10. Page 11. Page 12.
http://www.fsis.usda.gov/OPPDE/Comments ... IF-631.pdf
03-025IF 03-025IF-634 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-634 Linda A. Detwiler Page 2.
Page 3. Page 4. Page 5. Page 6. Page 7. Page 8.
http://www.fsis.usda.gov/OPPDE/Comments ... IF-634.pdf
Page 1 of 17 9/13/2005 [PDF]
... 2005 6:17 PM To: [email protected] Subject: [Docket
No. 03-025IFA]
FSIS Prohibition of the Use of Specified Risk Materials for Human Food ...
http://www.fsis.usda.gov/OPPDE/Comments ... 5IFA-2.pdf
03-025IFA 03-025IFA-6 Jason Frost [PDF]
... Zealand Embassy COMMENTS ON FEDERAL REGISTER 9 CFR Parts 309 et al
[Docket No. 03-
025IF] Prohibition of the Use of Specified Risk Materials for Human Food and
...
http://www.fsis.usda.gov/OPPDE/Comments ... 5IFA-6.pdf
In its opinion of 7-8 December 2000 (EC 2000), the SSC ... [PDF]
Page 1. Linda A. Detwiler, DVM 225 Hwy 35 Red Bank, New Jersey 07701 Phone:
732-741-2290
Cell: 732-580-9391 Fax: 732-741-7751 June 22, 2005 FSIS Docket Clerk US ...
http://www.fsis.usda.gov/OPPDE/Comments ... IF-589.pdf
3. Mad Cow Disease: FDA's Management of the Feed Ban Has Improved,
but Oversight Weaknesses Continue to Limit Program Effectiveness.
GAO-05-101, Feb. 25.
http://www.gao.gov/cgi-bin/getrpt?GAO-05-101
Highlights - http://www.gao.gov/highlights/d05101high.pdf
BSE; MRR; IMPORTATION OF LIVE BOVINES AND PRODUCTS
DERIVED FROM BOVINES [Docket No. APHIS-2006-0041] RIN 0579-AC01
FULL TEXT URL @
http://lists.ifas.ufl.edu/cgi-bin/wa.ex ... T=0&P=8374
http://lists.ifas.ufl.edu/cgi-bin/wa.ex ... T=0&P=3381
Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION]
http://www.fda.gov/ohrms/dockets/docket ... 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
http://www.fda.gov/ohrms/dockets/dailys ... 4be07.html
PART 2
http://www.fda.gov/ohrms/dockets/dailys ... 4be09.html
FOR IMMEDIATE RELEASE
P01-05
January 30, 2001
Print Media: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
--------------------------------------------------------------------------------
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
Today the Food and Drug Administration announced the results of tests taken on feed used at a Texas feedlot that was suspected of containing meat and bone meal from other domestic cattle -- a violation of FDA's 1997 prohibition on using ruminant material in feed for other ruminants. Results indicate that a very low level of prohibited material was found in the feed fed to cattle.
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.
http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html
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;
Risk of oral infection with bovine spongiform encephalopathy agent in primates
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
Summary The uncertain extent of human exposure to bovine spongiform encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease (vCJD)--is compounded by incomplete knowledge about the efficiency of oral infection and the magnitude of any bovine-to-human biological barrier to transmission. We therefore investigated oral transmission of BSE to non-human primates. We gave two macaques a 5 g oral dose of brain homogenate from a BSE-infected cow. One macaque developed vCJD-like neurological disease 60 months after exposure, whereas the other remained free of disease at 76 months. On the basis of these findings and data from other studies, we made a preliminary estimate of the food exposure risk for man, which provides additional assurance that existing public health measures can prevent transmission of BSE to man.
snip...
BSE bovine brain inoculum
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
Published online January 27, 2005
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.
http://www.bseinquiry.gov.uk/files/ws/s145d.pdf
2
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.
http://www.bseinquiry.gov.uk/files/ws/s147f.pdf
2) Infectious dose:
To cattle: 1 gram of infected brain material (by oral ingestion)
http://www.inspection.gc.ca/english/sci ... esbe.shtml
SADLY, DEC 2005 SHOWS THAT WE STILL HAVE A SERIOUS PROBLEM WITH BSE/TSE MAD COW DISEASE FEED
GAO
GAO-06-157R FDA Feed Testing Program
October 11, 2005
SNIP...FULL TEXT 29 PAGES ;
http://www.gao.gov/new.items/d06157r.pdf
Mad Cow Disease: An Evaluation of a Small Feed Testing Program FDA Implemented in 2003 With Recommendations for Making the Program a Better Oversight Tool. GAO-06-157R, October 11
http://www.gao.gov/cgi-bin/getrpt?GAO-06-157R
CVM Update
November 2005 Update on Feed Enforcement Activities to Limit the Spread of BSE
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
http://www.fda.gov/cvm/5580.htm
[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
Terry S. Singeltary
Page 1 of 17
From: Terry S. Singeltary Sr. [[email protected]]
Sent: Thursday, September 08, 2005 6:17 PM
To: [email protected]
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 ;
http://www.fsis.usda.gov/OPPDE/Comments ... 5IFA-2.pdf
AND WHOM HAVE THE FEEDERS PROTECTED IN THE PAST FROM MAD COW DISEASE AND WHAT WAS THERE MAJOR CONCERNS $
STRICTLY PRIVATE AND CONFIDENTIAL 25, AUGUST 1995
snip...
To minimise the risk of farmers' claims for compensation from feed
compounders.
To minimise the potential damage to compound feed markets through adverse publicity.
To maximise freedom of action for feed compounders, notably by
maintaining the availability of meat and bone meal as a raw
material in animal feeds, and ensuring time is available to make any
changes which may be required.
snip...
THE FUTURE
4..........
MAFF remains under pressure in Brussels and is not skilled at
handling potentially explosive issues.
5. Tests _may_ show that ruminant feeds have been sold which
contain illegal traces of ruminant protein. More likely, a few positive
test results will turn up but proof that a particular feed mill knowingly
supplied it to a particular farm will be difficult if not impossible.
6. The threat remains real and it will be some years before feed
compounders are free of it. The longer we can avoid any direct
linkage between feed milling _practices_ and actual BSE cases,
the more likely it is that serious damage can be avoided. ...
SEE full text ;
http://www.bseinquiry.gov.uk/files/yb/1 ... 002001.pdf
A failed policy by a failed and corrupt administration.
THIS is what happens when you have the industry run the government.
TSS
