DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service Food and Drug Administration Rockville MD 20857
Terry Singeltary
P.O. box 42.
Bacliff, TX USA 77518
Dear Requestor
In reply refer to: F2009-7430
This is in response to your Freedom of Information Act (FOIA) request received by the Food and Drug Administration (FDA) on September 10,2009 which you ask for Recall V-258-2009. I apologize for the delay in our response to you. Enclosed you will find the records you requested. The following charges will be included in a monthly invoice:
Reproduction Search Review Total 5 Pages hour $.50 $ $.50
The above charges may not reflect final charges for this request. Please DO NOT send any payment until you receive an invoice from the Agency's Freedom of Information Staff (HFI-35).
Sincerely yours,
Sandy McGeehan
Paralegal Specialist
Communications Staff
Center for Veterinary Medicine
Memorandum
Date August 26, 2009
From CVM Animal Health Hazard Evaluation Committee
Subject Problem:
Fargam Land & Grain recalled 429,128 pounds of ground corn because it may have been contaminated with prohibited material (material prohibited for use in ruminant feed by the 1997 BSE feed regulation) and was not labeled with the cautionary statement.
The feed mill received two semi trailer loads of barley that had been recalled by Mars Petcare US because it had been contaminated by dog food, some of which is formulated to contain bovine origin meat and bone meal.
The auger used to receive the barley was used to receive two truck loads of corn before the feed mill became aware of the problem with the barley. This potentially allowed some of the dog food in the barley to be carried over into the corn.
Recall Event IDIRES #: 52103
DAF/Surveillance #: 09234
CVM Recall and Emergency Coordinator (Kathy Hemming-Thompson), HFV -234
Field/RES Report Data:
Recalling firm:
Fargam Land & Grain
505 Burlington Rd
Saginaw, TX 76179
Manufacturer:
Mars Petcare US
1 Doane Rd Clinton, OK 73601
Product & Code: Bulk ground corn; 70AY -02
Quantity Manufactured: 429,128 pounds
Quantity Distributed: 429,128 pounds
Recall Contact: Phil Farr, Owner, Fargam Land & Grain, Saginaw, TX
FDA District: Dallas
Field Recommended Classification: Class III
Effectiveness Check Level: Direct Accounts
Page 2 of 4 - DAF 09234 - Health Hazard Evaluation
Background: The firm is a feed mill that stores and manufactures products intended for use in animal feed. Its business is commingled with Saginaw Flakes, a feed mill which is under the same ownership, and located across the street from Fargam Land & Grain. A limited inspection was conducted to determine compliance with CP 7371.009 after the firm notified the Office of the Texas State Chemist that it had received four semi trailer loads of barley that may have contained dog food.
ReView:
Sample collection:
Aseptic technique [ ] Yes [ ] No [X] NA
Number of subsamples
FDA/FACTS #
Was chain of custody documented correctly?
[ ] Yes
[ ] No Explain in narrative box:
[X] NA
Analytical method: [ ] Yes [ ] No [X] NA
[ ] Official method
[ ] FDA method
[ ] Other method, explain in narrative box:
Was analysis properly conducted? [ ]Yes [ ] No Explain in narrative box: [X] NA
Laboratory analysis: [ ] Yes [ ] No [X] NA
Done by:
[ ] FDA laboratory
[ ] State laboratory
[ ] Other laboratory
[ ] None
Have any adverse reaction reports or other indication of injuries or diseases been reported relating to this problem or for similar situations?
[X] No
[ ] Yes Attach copies or explain in narrative box:
[ ] NA
Is the problem easily identified by the user?
[X] No
[ ] Yes
What are the animal and human populations at risk?
Cattle, particularly calves, is the population that is most susceptible to BSE and at greatest risk ofexposure to the BSE agent through these shipments of ground corn that may have contained prohibited material and were not labeled with the cautionary statement. Other susceptible populations, such as humans, domestic cats, and zoo animals are best protected by keeping BSE out of the cattle population.
Page 3 of 4 - DAF 09234 - Health Hazard Evaluation
What is the hazard associated with use of the product?
[X ] Life-threatening (death has or could occur) .
[ ] Results in permanent impaiiment of a body function or permanent damage to a body structure
[ ] Necessitates medical or surgical intervention to preclude or reverse permanent damage to a body structure orpermanent impairment of a body function
[ ] Temporary-or reversible (without medical intervention)
[ ] Limited (transient, minor impairment or complaints)
[ ] No adverse health consequences
[ ] Hazard cannot be assessed with the data currently available
What is the likelihood of an adverse event occurring?
[ ] Probable
[ ] Possible
[X] Unlikely
[ ] Unknown
CVM's AHHE Committee recommends the following:
a) Recall Classification: [21 CFR 7.41(b) and RPM 5-00-20 (j)].
l-Class I [ ]
2-Class ll [ ]
3-Class III [X]
4-Market withdrawal [ ] Skip parts b & c
5-0ther [ ] Skip parts b & c.
b) Depth of Recall: [21 CFR 7 .42(b )(1) and RPM 5-00-20(k)].
l-Consumer or User Level [X]
2- Retail Level/Veterinarian [ ]
3- Wholesale Level [ ]
4-NA [ ]
c) Level of Audit Checks: [Investigations Operations Manual Chapter 7, Section 7.3.2.2]
[ ] Level A-I 00% of the total number of consignees to be contacted.
[ ] Level B - Greater than 10% but less than 100% of the total number of consignees to be contacted.
[ ] Level C - 10% of the total number of consignees to be contacted.
[ ] Level D - 2% of the total number of consignees to be contacted.
[ X] Level E - No checks.
Narrative Summary:
Fargam Land & Grain, Saginaw, TX recalled 429,128 pounds of ground corn that may have contained prohibited material. The com was not labeled with the required cautionary statement to alert users of the product that it should not be fed to ruminants or be used as an ingredient in
Page 4 of 4 - DAF 09234 - Health Hazard Evaluation
ruminant feed. The corn was shipped to eleven dairy farms in Texas and one dairy farm in Louisiana between May 13th and May 15th, 2009. This is a sub-recall of a recall by Mars Petcare US, Clinton, OK of bulk whole barley that was cross-contaminated with dog food during storage and loading at the Mars Petcare plant. A receiving auger at Fargam Land and Grain that was used to unload the contaminated barley was used to unload whole corn before the problem was discovered. This potentially allowed some of the dog food in the barley to be carried over into the corn.
BSE is a degenerative disease of the central nervous system of cattle and is always fatal. It is characterized by a long incubation period of three to eight years, followed by a much shorter course of illness. The BSE agent is also the cause of variant Creutzfeldt-Jakob disease in humans, which is also always fatal.
While the health hazard is life threatening, It is highly unlikely that deaths or illnesses would result from the use of the recalled product. The meat and bone meal ingredient of the dog food carried over into the barley as a result of cross contamination, and then potentially carried over into the corn through cross-contamination, would have to have been derived from a BSE infected animal for the BSE agent to be present in the dog food-barley, and corn. This is unlikely due to the low prevalence of BSE in the U.S. cattle population. In 2006, USDA estimated the prevalence of BSE in the United States to be less than one infected animal per million adult cattle. This estimate was based on results of 735,213 cattle tested over a seven year period. The most recent of only three BSE cases ever detected in the United States was found in March 2006.
CVM Animal Health Hazard Evaluation Committee recommends a class _III_ recall and we concur with the effectiveness check level of _100_ percent.
Animal Health Hazard Evaluation Committee
Lynn Post, DVM, Ph.D., D.A.B.V.T., Chair
Sharon Benz, Ph.D., PAS
Terry Proescholdt, Leader, Feed Safety Team
Prepared by :
Burt Pritchett, DVM
end...March 4, 2010...TSS
HISTORY F.O.I.A.
Saturday, August 29, 2009
FOIA REQUEST FEED RECALL 2009 Product may have contained prohibited materials Bulk Whole Barley, Recall # V-256-2009
http://madcowfeed.blogspot.com/2009/08/foia-request-feed-recall-2009-product.htmlThursday, September 3, 2009
429,128 lbs. feed for ruminant animals may have been contaminated with prohibited material Recall # V-258-2009
http://madcowfeed.blogspot.com/2009/09/429128-lbs-feed-for-ruminant-animals.htmlFriday, September 4, 2009
FOIA REQUEST ON FEED RECALL PRODUCT 429,128 lbs. feed for ruminant animals may have been contaminated with prohibited material Recall # V-258-2009
http://madcowfeed.blogspot.com/2009_09_01_archive.htmlTuesday, November 3, 2009
re-FOIA REQUEST ON FEED RECALL PRODUCT contaminated with prohibited material Recall # V-258-2009 and Recall # V-256-2009
http://madcowfeed.blogspot.com/2009/11/re-foia-request-on-feed-recall-product.htmlFrom: Terry S. Singeltary Sr.
To:
CVMHomeP@cvm.fda.gov Cc:
FOIASTAFF@oig.usda.gov ;
paffairs@oig.hhs.gov ;
HHSTips@oig.hhs.gov ;
phyllis.fong@oig.usda.gov FOIA REQUEST ON FEED RECALL PRODUCT 429,128 lbs. feed for ruminant animals may have been contaminated with prohibited material Recall # V-258-2009
September 4, 2009
TO:
Food and Drug Administration
Division of Freedom of Information (HFI-35)
Office of Shared Services
Office of Public Information and Library Services
5600 Fishers Lane
Rockville, MD 20857
Or requests may be sent via fax to: fax number 301-443-1726 or 301-443-1719. If experience difficulty sending a fax, please call (301) 443-2414.
FROM:
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
Greetings FDA FOIE, and the Honorable Phyllis Fong et al @ OIG FOIA,
ANOTHER FOIA REQUEST PLEASE !
PLEASE SEE FULL TEXT ;
Canine Spongiform Encephalopathy CSE TSE
>>> Is anybody even looking at the dogs..especially with CWD now so widespread? <<<
NA, na, na........they know what they will find, Canine Spongiform Encephalopathy, and it was documented, but then they decided not to push the issue anymore, they had enough mad cow disease in different species to deal with. so they screwed the brains up with dogs and deer in the UK. then we took a page or two from the UKs testing protocols and USDA screwed the brains up with cattle, again, and again, and again. then played the stupid card. ya can't fix stupid. ... TSS
Monday, March 8, 2010
Canine Spongiform Encephalopathy aka MAD DOG DISEASE
Greetings,
Another Big Myth about Transmissible Spongiform Encephalopathy, is that TSE will not transmit to dogs. This is simply NOT TRUE. IT is perfectly legal to feed dogs and cats here in the USA bovine meat and bone meal. Canine dementia is real. how many dogs and cats here in the USA are tested for mad cow disease ? I just received this F.O.I.A. request, and thought I would post it here with a follow up on MAD DOG DISEASE. This is a follow up with additional data I just received on a FOIA request in 2009 ;
see full text, and be sure to read the BSE Inquiry documents toward the bottom ;
http://caninespongiformencephalopathy.blogspot.com/2010/03/canine-spongiform-encephalopathy-aka.htmlMonday, March 8, 2010 UPDATE 429,128 lbs. feed for ruminant animals may have been contaminated with prohibited material Recall # V-258-2009
http://madcowfeed.blogspot.com/2010/03/update-429128-lbs-feed-for-ruminant.htmlMonday, March 1, 2010
ANIMAL PROTEIN I.E. MAD COW FEED IN COMMERCE A REVIEW 2010
http://madcowfeed.blogspot.com/2010/03/animal-protien-ie-mad-cow-feed-in.htmlKind Regards,
Terry
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