OIG VULNERABILITIES IN FDA’S OVER SIGHT OF STATE FOOD FACILITY INSPECTIONS

FDA faulted over state inspections

(Ric Feld/ASSOCIATED PRESS) - A 2009 salmonella outbreak linked to a Georgia peanut plant occurred after several state inspections.

Published: December 14

The Food and Drug Administration is relying more often on states to inspect food plants but is failing to properly monitor those state inspections or follow through on their findings, the Department of Health and Human Services watchdog has concluded.

In a report released Wednesday, the department’s inspector general found that a lack of resources is forcing the FDA to lean more heavily on its counterparts at the state level to inspect plants responsible for everything from packing to processing foods.

More than half the agency’s inspections were done by state officials in fiscal 2009, up from 42 percent four years earlier, according to the report. If these inspections are not done properly, they can expose consumers to sometimes life-threatening illnesses.

A deadly salmonella outbreak linked to a Georgia peanut processing plant in 2009 occurred after the plant had been inspected several times by state officials working on the FDA’s behalf. The incident prompted Rep. Rosa DeLauro (D-Conn.) to ask Inspector General Daniel Levinson to examine the FDA’s oversight of its state partners.

Wednesday’s report confirms several weaknesses in that relationship, almost all of which the FDA acknowledged were indeed problems. “The report documents glitches we’re aware of. . . . These are things we are working on,” said Mike Taylor, the FDA’s deputy commissioner for foods.

The report found that the FDA has failed to ensure that the states have completed the number of inspections assigned to them. Of the 41 states the FDA was working with in 2009, eight did not complete 10 percent of the 2,170 inspections they were responsible for that year. The agency paid for 130 of the inspections that were not done.

The report did not specify how much was paid in those instances. But it did state that the FDA spent more than $8 million for state contract inspections in fiscal 2009.

The FDA also did not do its part in monitoring the inspections as required by law, according to the report.

Each year, the FDA has to audit at least 7 percent of a state’s inspections. That means that an FDA official must tag along to observe a state inspector’s performance and identify any systemic issues — such as problems that consistently emerge in multiple audits. But the agency failed to complete the required audits in 14 states, and therefore can’t determine the effectiveness of those state inspections, the report said.

“FDA officials generally attributed their inability to complete the required number of audits to a lack of resources,” the report said. An official in one of the FDA’s 14 districts said his district ran out of travel funds. Another said his district lacked trained auditors.

Even in cases where recurring problems were identified, the problems were not always addressed. Corrective action was taken in only four of the 10 states where systemic problems were found, the report said.

When audits were conducted, the most common problem cited had to do with the state inspectors’ inability to identify violations. At least 32 percent of the 419 inspectors audited had at least one deficiency. The report cited instances in which inspectors failed to note evidence of rodents or a leaky roof above exposed food.

Even when inspectors noted food safety violations, FDA officials who reviewed the inspectors’ reports did not properfly classify all of them, the report said. Officials responsible for 11 states said they did not classify some incidents as serious and in need of official action because they thought they were not allowed to, the report said.

Officials in another 11 states said that FDA was not always notified when actions were taken and therefore could not determine if the violations were properly addressed.

“Taken together, these findings demonstrate that more needs to be done to protect public health and to ensure that contract inspections are effective,” the report concluded.

Aside from the resource issues, FDA officials told investigators that the agency relies heavily on the states in part because states have more enforcement power than the federal government. For instance, state officials can sometimes instantly shut down a plant or seize unsafe food, whereas FDA cannot achieve the same instant results.

DeLauro, the congresswoman who requested the report, said that it “illustrates a vicious cycle of woefully inadequate oversight. It is clear to me that more must be done to ensure that federal inspection and oversight of food facilities best protects the public health.”

The Food Safety Modernization Act, adopted by the previous Congress, would grant the FDA more authority. But it would also demand that the agency take on more inspections and work more with the states to keep the food supply safe.


http://www.washingtonpost.com/business/economy/2011/12/14/gIQAqBrtuO_story.html



Department of Health and Human Services

OFFICE OF INSPECTOR GENERAL

VULNERABILITIES IN FDA’S OVER SIGHT OF STATE FOOD FACILITY INSPECTIONS

Daniel R. Levinson Inspector General December 2011 OEI-02-09-00430

EXECUTIVE SUMMARY

OBJECTIVES

1. To determine the extent to which the Food and Drug Administration (FDA) enters into contracts with States to inspect food facilities.

2. To determine the extent to which FDA ensures that States complete the inspections required by their contracts.

3. To determine whether FDA ensures that State inspections are properly classified and violations are remedied.

4. To determine the extent to which FDA audits State inspections and addresses deficiencies identified by audits.

BACKGROUND

Each year, 128,000 Americans are hospitalized and 3,000 die after consuming contaminated foods and beverages. FDA is responsible for safeguarding the Nation’s food supply and for routinely inspecting food facilities. In addition to conducting its own inspections, FDA relies on State agencies to conduct inspections on its behalf; however, in recent years, concerns have been raised about the rigor of these State inspections. For example, the peanut processing plant responsible for a 2009 salmonella outbreak was inspected multiple times by a State agency working on behalf of FDA. This outbreak resulted in one of the largest food recalls in U.S. history and has led to serious questions about the effectiveness of State food facility inspections. Because of concerns about food facility inspections conducted by State agencies, this review was requested by the House Committee on Appropriations, Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies.

FDA often enters into contracts with State agencies responsible for ensuring food safety. Each contract includes the number of food facility inspections the State will conduct for FDA and the amount the State will be paid for each inspection. During the 2009 contract year, FDA held contracts with 41 States to conduct FDA’s inspections.

FDA oversees State inspections though its Contract Inspection Audit Program. The audit program is designed to verify that States conduct inspections that satisfy the requirements of their contracts. FDA requires that a minimum of 7 percent of a State’s contract inspections be audited each year. This minimum percentage—which is known as the minimum audit rate—ensures that States are conducting adequate inspections that meet the conditions of the contract.

We based this study on several sources of data: (1) FDA’s inspection data, (2) FDA’s documentation of contract inspections and payment data, (3) audit and corrective action documentation, and (4) structured interviews with FDA officials.

FINDINGS

FDA has increasingly relied on States to inspect food facilities. Although the number of food facilties inspected by FDA has decreased since 2004, the number of facilities inspected by States under contract to FDA has increased significantly. In fiscal year (FY) 2009, 59 percent of FDA’s food inspections were conducted by State inspectors, compared to only 42 percent in FY 2004.

In eight States, FDA failed to ensure that the required number of inspections was completed; FDA paid for many inspections that were incomplete. These 8 States were responsible for completing a total of 2,170 inspections; however, these States failed to complete 10 percent of these inspections during the contract year. When States fail to complete the inspections required in their contracts, FDA’s ability to identify facilities with potentially serious food safety violations is diminished. Also, FDA paid for 130 of the 221 inspections that were not completed. In four additional States, FDA paid for inspection visits, even though payment for such visits was not specified in the States’ contracts. FDA did not ensure that all State inspections were properly classified and that all violations were remedied. FDA officials responsible for 11 of 41 States were unclear about how to properly classify contract inspections. In these 11 States, FDA officials reported that they would not assign official action indicated classifications to State inspections under any circumstances, contrary to FDA guidance. If FDA does not correctly classify inspections that reveal serious violations, its ability to assess facilities’ relative risk is impaired. Additionally, FDA officials responsible for another 11 States reported that when States were responsible for correcting violations, FDA was not always informed about actions taken by the States. As a result, FDA was unable to ensure that serious violations had been adequately addressed.

FDA failed to complete the required number of audits for one-third of the States and did not always follow up on systemic problems identified. For 14 of 41 States with contracts, FDA did not complete the required number of audits and therefore failed to meet its minimum audit rate. Additionally, the audits in 10 States revealed systemic problems that needed to be corrected; however, FDA initiated corrective action in only 4 of the 10 States. If FDA does not follow its guidance and complete the required number of audits and address systemic problems, it cannot verify that States are conducting suitable inspections that satisfy the requirements of the contracts.

RECOMMENDATIONS

Our report identified significant weaknesses in FDA’s oversight of food facility inspections conducted by States. Taken together, the findings demonstrate that more needs to be done to protect public health and to ensure that contract inspections are effective and prevent outbreaks of foodborne illness. Therefore, we recommend that FDA:

Ensure that all contract inspections are completed, properly documented, and appropriately paid for.

Ensure that contract inspections are properly classified in accordance with FDA guidance.

Ensure that all inspection violations are remedied by routinely tracking all actions taken to correct violations.

Ensure that the minimum audit rate is met in all States.

Address any systemic problems identified by audits.

AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL RESPONSE

FDA concurred with four of our recommendations and agreed in part with the fifth.

In response to our first recommendation, to ensure that all contract inspections are completed, properly documented, and appropriately paid for, FDA concurred, stating that it is conducting a systematic review of the State contracting program.

In response to our second recommendation, to ensure that contract inspections are properly classified, FDA concurred and noted that it is revising its directive to emphasize more clearly that classifications must be accurate, timely, and uniform.

In response to our third recommendation, to ensure that all inspection violations are remedied by routinely tracking all actions taken to correct violations, FDA agreed to track most violative inspections and the remedies taken by industry. However, FDA noted that certain violations may not be suitable for inspection followup and that other approaches may be used to track such violations. While we appreciate FDA’s commitment to track certain violations, we encourage it to track all violations, even those that do not warrant followup inspections. FDA can use violation information to help establish the relative risk of facilities and determine how often they should be inspected. In response to our fourth recommendation, to ensure that the minimum audit rate is met in all States, FDA concurred, noting that it is reviewing the current reporting requirements to ensure that audits are completed and tracked to verify compliance with FDA requirements.

Finally, in response to our fifth recommendation, to address any systemic problems identified by audits, FDA concurred and noted that it will continue to develop processes and procedures to ensure that systemic problems are identified and that corrective action plans are implemented.

We support FDA’s efforts to strengthen State contract inspections and address the issues identified in the report. With the implementation of the Manufactured Food Regulatory Program Standards, FDA’s oversight of State inspections is even more critical. As States adopt the standards, it is essential that FDA strengthen not only States’ oversight but also its own oversight to ensure that States conduct high-quality food facility inspections.

snip...

Identifying Inspection Violations

During an inspection, State inspectors may identify potential violations of food safety laws and regulations. These violations are recorded in the inspection report. Based on the inspection report, FDA generally assigns one of three classifications: official action indicated (OAI), voluntary action indicated (VAI), or no action indicated (NAI).10 An OAI classification signifies that the inspector found objectionable conditions in the food facility and that these violations potentially “warrant regulatory action.”11 This type of violation is the most significant identified by inspectors. A VAI classification signifies that the inspector found violations that are serious enough to record but do not cross “the threshold for regulatory action.”12 An NAI classification signifies that the inspector found either no violations of law and regulations or violations that were so insignificant that no action is warranted.13

snip...


http://oig.hhs.gov/oei/reports/oei-02-09-00430.pdf



PLEASE NOTE, FDA LAST BSE MAD COW FEED REPORT WAS ALMOST A YEAR AGO (they use to come out weekly, then monthly, then quarterly, now I guess only yearly) ;



2011

January 13, 2011 January 2011 Update on Feed Enforcement Activities to Limit the Spread of BSE


http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm239959.htm





Monday, January 17, 2011

MAD COW Update on Feed Enforcement Activities to Limit the Spread of BSE January 13, 2011

snip...

Subject: BSE FEED VIOLATIONS UPDATE From 01/01/2009 To 06/10/2009

FDA BSE/Ruminant Feed Inspections Firms Inventory Report

Data reported as of: 06/06/2009 Search by: Last BSE Insp Date From 01/01/2009 To 06/10/2009 Sort by: FDA District, State, Firm Name

FDA District Firm Id (FEI) Firm Name Street Address City State Zip Code Opr. Status Firm Type(s) Prgm Risk Last BSE Insp Date Last BSE Dist. Dcsn** Handles Feed for Rum. Animals?

ATL-DO 3007582627 Hoffner Brothers Dairy 610 Ketchie Rd Mount Ulla NC 28125-9685 OPR FR, OF, OT NP 02/03/2009 VAI Y

CIN-DO 3002766655 Lester J Stutzman Feed Mill 2811 Mt Zion Rd Marion KY 42064 OPR DR, FR, NL, OF DP 01/05/2009 VAI Y

CIN-DO 3003407434 Direct Action Co Inc 6668 Old SR 39 NW Dover OH 44622 OPR DR, NL, OT HP 05/04/2009 VAI Y

KAN-DO 1000050408 Mid-South Milling Co Inc 213 Central Ave Kansas City KS 66118-1117 OPR OT, PB, TH HP 01/14/2009 VAI N

KAN-DO 3007495971 Midwest Bulk Inc 3404 N Emporia St Wichita KS 67219-3615 OPR TH DP 02/26/2009 VAI Y

KAN-DO 3007458821 Murray Grain Co Inc 900 E 21st St N Ste 201 Wichita KS 67214-1406 OPR TH DP 02/26/2009 VAI Y

KAN-DO 3006292356 Orscheln Farm & Home 1702 W 11th St Coffeyville KS 67337-3115 OPR DR DP 02/02/2009 VAI Y

LOS-DO 2027094 Nestle, USA/ Nestle Prepared Foods Company 9601 Canoga Ave Chatsworth CA 91311-4115 OPR HF HP 05/26/2009 VAI N

NYK-DO 1310558 Birkett Mills 1 Main St Penn Yan NY 14527-1615 OPR DR, HF, NL NP 01/11/2009 RTS Y

Data reported as of: 06/06/2009 Search by: Last BSE Insp Date From 01/01/2003 To 06/10/2009 and Last BSE District Decision = OAI Sort by: FDA District, State, Firm Name

FDA District Firm Id (FEI) Firm Name Street Address City State Zip Code Opr. Status Firm Type(s) Prgm Risk Last BSE Insp Date Last BSE Dist. Dcsn** Handles Feed for Rum. Animals?

KAN-DO 1927975 Hahn & Phillips Grease Co Inc 913 N Odell, PO Box 130 Marshall MO 65340 OPR NL, PB, TH HP 12/22/2008 OAI Y

Legend - Opr.Status:OPR=Operational, SEA=Seasonal, PRP=Pre-Production, Firm Type: AF=Animal Feed/Pet Food Salvager, DR=Distributor/Retailer, FL=Feed Mill (FDA Licensed), FR=Feeder of Ruminants, HF=Human Food Processor, NL=Feed Mill (not FDA Licensed), OF=On-farm Feed Mixer, OT=Other, PB=Protein Blender, PF=Pet Food Manufacturer, RE=Renderer, RO=Feeder of Ruminants and Other Species, TH=Transporter (Hauler), Prgm Risk:DP=Only Distributes Prohib.Mat.(DP), HP=Handles Prohibited Materials(HP), NP=Does not handle Prohib.Mat.(NP), Dist Dcsn:OAI=Official Action Indicated (OAI), VAI=Voluntary Action Indicated (VAI), NAI=No Action Indicated (NAI), RTS=Referred to State (RTS),


http://www.accessdata.fda.gov/BSEInspect/bse_excel.jsp



February 6, 2004

To help prevent the establishment and amplification of BSE through feed in the United States, FDA implemented a final rule that prohibits the use of most mammalian protein in feeds for ruminant animals. This rule, Title 21 Part 589.2000 of the Code of Federal Regulations, became effective on August 4, 1997.

This is an update on FDA enforcement activities regarding the ruminant feed (BSE) regulation. FDA's CVM has assembled data from the inspections that have been conducted AND whose final inspection report has been recorded in the FDA's inspection database as of January 23, 2004. As of January 23, 2004, FDA had received over 26,000 inspection reports. The majority of these inspections (around 70%) were conducted by State officials under contract to FDA, with the remainder conducted by FDA officials.

Inspections conducted by FDA or State investigators are classified to reflect the compliance status at the time of the inspection based upon the objectionable conditions documented. These inspection conclusions are reported as Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI).

An OAI inspection classification occurs when significant objectionable conditions or practices were found and regulatory sanctions are warranted in order to address the establishment's lack of compliance with the regulation. An example of an OAI inspection classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspections classified with OAI violations will be promptly re-inspected following the regulatory sanctions to determine whether adequate corrective actions have been implemented

A VAI inspection classification occurs when objectionable conditions or practices were found that do not meet the threshold of regulatory significance, but do warrant advisory actions to inform the establishment of findings that should be voluntarily corrected. Inspections classified with VAI violations are more technical violations of Title 21 Part 589.2000 of the Code of Federal Regulations, (here called the Ruminant Feed Ban) became effective on August 4, 1997. Ruminant Feed Ban provisions such as minor recordkeeping lapses and conditions involving non-ruminant feeds.

A NAI inspection classification occurs when no objectionable conditions or practices were found during the inspection or the significance of the documented objectionable conditions found does not justify further actions.

The results to date are reported here both by “segment of industry” and “in total”. NOTE – A single firm can operate as more than one firm type. As a result, the categories of the different industry segments are not mutually exclusive.


http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm048448.htm



Greetings,


THERE were 100s of NAI's, but you get the just. also, please note ;



“A VAI inspection classification occurs when objectionable conditions or practices were found that do not meet the threshold of regulatory significance, but do warrant advisory actions to inform the establishment of findings that should be voluntarily corrected. Inspections classified with VAI violations are more technical violations of Title 21 Part 589.2000 of the Code of Federal Regulations, (here called the Ruminant Feed Ban) became effective on August 4, 1997. Ruminant Feed Ban provisions such as minor recordkeeping lapses and conditions involving non-ruminant feeds. “




PLEASE note, most of the VAIs DID handle feed for ruminant animals. sure would be nice to be able to read the complete report, on a single page, for each violation, on a single day, given once a week, at a simple url, like it use to be. here is an example ;


snip...

please see my full report here ;


Monday, January 17, 2011

MAD COW Update on Feed Enforcement Activities to Limit the Spread of BSE January 13, 2011


http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/mad-cow-update-on-feed-enforcement.html



Saturday, August 14, 2010

BSE Case Associated with Prion Protein Gene Mutation

(g-h-BSEalabama) and VPSPr PRIONPATHY

(see mad cow feed in COMMERCE IN ALABAMA...TSS)


http://prionpathy.blogspot.com/2010/08/bse-case-associated-with-prion-protein.html





P.9.21

Molecular characterization of BSE in Canada

Jianmin Yang1, Sandor Dudas2, Catherine Graham2, Markus Czub3, Tim McAllister1, Stefanie Czub1 1Agriculture and Agri-Food Canada Research Centre, Canada; 2National and OIE BSE Reference Laboratory, Canada; 3University of Calgary, Canada

Background: Three BSE types (classical and two atypical) have been identified on the basis of molecular characteristics of the misfolded protein associated with the disease. To date, each of these three types have been detected in Canadian cattle.

Objectives: This study was conducted to further characterize the 16 Canadian BSE cases based on the biochemical properties of there associated PrPres. Methods: Immuno-reactivity, molecular weight, glycoform profiles and relative proteinase K sensitivity of the PrPres from each of the 16 confirmed Canadian BSE cases was determined using modified Western blot analysis.

Results: Fourteen of the 16 Canadian BSE cases were C type, 1 was H type and 1 was L type. The Canadian H and L-type BSE cases exhibited size shifts and changes in glycosylation similar to other atypical BSE cases. PK digestion under mild and stringent conditions revealed a reduced protease resistance of the atypical cases compared to the C-type cases. N terminal- specific antibodies bound to PrPres from H type but not from C or L type. The C-terminal-specific antibodies resulted in a shift in the glycoform profile and detected a fourth band in the Canadian H-type BSE.

Discussion: The C, L and H type BSE cases in Canada exhibit molecular characteristics similar to those described for classical and atypical BSE cases from Europe and Japan. This supports the theory that the importation of BSE contaminated feedstuff is the source of C-type BSE in Canada. *** It also suggests a similar cause or source for atypical BSE in these countries.


http://www.prion2009.com/sites/default/files/Prion2009_Book_of_Abstracts.pdf



North Dakota Firm Recalls Whole Beef Head Products That Contain Prohibited Materials

Recall Release CLASS II RECALL FSIS-RC-023-2010 HEALTH RISK: LOW

Congressional and Public Affairs (202) 720-9113 Catherine Cochran

WASHINGTON, April 5, 2010 - North American Bison Co-Op, a New Rockford, N.D., establishment is recalling approximately 25,000 pounds of whole beef heads containing tongues that may not have had the tonsils completely removed, which is not compliant with regulations that require the removal of tonsils from cattle of all ages, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

Tonsils are considered a specified risk material (SRM) and must be removed from cattle of all ages in accordance with FSIS regulations. SRMs are tissues that are known to contain the infective agent in cattle infected with Bovine Spongiform Encephalopathy (BSE), as well as materials that are closely associated with these potentially infective tissues. Therefore, FSIS prohibits SRMs from use as human food to minimize potential human exposure to the BSE agent.

The product subject to recall includes: Various weight cases of "Beef Heads KEEP FROZEN." Each case bears the establishment number "EST. 18859" inside the USDA mark of inspection and a case code number "16999." "North Dakota Natural Beef" is printed in the bottom left-hand corner of each label.

The recalled products were produced between June 25, 2009, and February 19, 2010. These products were shipped to distribution centers in Md., Mich., and Minn. for further sale.

The problem was discovered during FSIS inspection activities at the establishment. FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.

Media with questions about the recall should contact Philip Wicke, Vice President of Operations, at (701) 356-7723. Consumers with questions about the recall should contact Jeremy Anderson, Director of Customer Service, at (952) 545-2495.

Consumers with food safety questions can "Ask Karen," the FSIS virtual representative available 24 hours a day at AskKaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day. #


http://www.fsis.usda.gov/News_&_Events/Recall_023_2010_Release/index.asp



Thursday, June 26, 2008

Texas Firm Recalls Cattle Heads That Contain Prohibited Materials


http://madcowfeed.blogspot.com/2008/06/texas-firm-recalls-cattle-heads-that.html



Tuesday, July 1, 2008

Missouri Firm Recalls Cattle Heads That Contain Prohibited Materials SRMs


http://madcowfeed.blogspot.com/2008/07/missouri-firm-recalls-cattle-heads-that.html





Friday, August 8, 2008

Texas Firm Recalls Cattle Heads That Contain Prohibited Materials SRMs 941,271 pounds with tonsils not completely removed


http://madcowfeed.blogspot.com/2008/08/texas-firm-recalls-cattle-heads-that.html




Saturday, April 5, 2008

SRM MAD COW RECALL 406 THOUSAND POUNDS CATTLE HEADS WITH TONSILS KANSAS


http://cjdmadcowbaseoct2007.blogspot.com/2008/04/srm-mad-cow-recall-406-thousand-pounds.html



Wednesday, April 30, 2008

Consumption of beef tongue: Human BSE risk associated with exposure to lymphoid tissue in bovine tongue in consideration of new research findings


http://cjdmadcowbaseoct2007.blogspot.com/2008/04/consumption-of-beef-tongue-human-bse.html



Sunday, October 18, 2009

Wisconsin Firm Recalls Beef Tongues That Contain Prohibited Materials SRM WASHINGTON, October 17, 2009


http://madcowfeed.blogspot.com/2009/10/wisconsin-firm-recalls-beef-tongues.html



Thursday, October 15, 2009

Nebraska Firm Recalls Beef Tongues That Contain Prohibited Materials SRM WASHINGTON, Oct 15, 2009


http://madcowfeed.blogspot.com/2009/10/nebraska-firm-recalls-beef-tongues-that.html


http://madcowfeed.blogspot.com/




http://madcowspontaneousnot.blogspot.com/




10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. BLOOD LACED 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/2007/ENF00996.html



NEW URL


http://www.fda.gov/Safety/Recalls/EnforcementReports/2007/ucm120446.htm





Thursday, March 19, 2009

MILLIONS AND MILLIONS OF POUNDS OF MAD COW FEED IN COMMERCE USA WITH ONGOING 12 YEARS OF DENIAL


http://madcowfeed.blogspot.com/2009/03/millions-and-millions-of-pounds-of-mad.html



Friday, 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/foia-request-on-feed-recall-product.html




and all this was confirmed here ;


C O N F I R M E D

----- Original Message -----

From: "Terry S. Singeltary Sr."

To:

Sent: Thursday, November 05, 2009 9:25 PM

Subject: [BSE-L] 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.html



Thursday, November 12, 2009

BSE FEED RECALL Misbranding of product by partial label removal to hide original source of materials 2009


http://madcowfeed.blogspot.com/2009/11/bse-feed-recall-misbranding-of-product.html



Tuesday, March 2, 2010

Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded Rangen Inc 2/11/10 USA


http://madcowfeed.blogspot.com/2010/03/animal-proteins-prohibited-in-ruminant.html



Monday, 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.html



Monday, April 5, 2010

Update on Feed Enforcement Activities to Limit the Spread of BSE April 5, 2010


http://madcowfeed.blogspot.com/2010/04/update-on-feed-enforcement-activities.html



Saturday, July 23, 2011

CATTLE HEADS WITH TONSILS, BEEF TONGUES, SPINAL CORD, SPECIFIED RISK MATERIALS (SRM's) AND PRIONS, AKA MAD COW DISEASE


http://transmissiblespongiformencephalopathy.blogspot.com/2011/07/cattle-heads-with-tonsils-beef-tongues.html




Saturday, November 6, 2010

TAFS1 Position Paper on Position Paper on Relaxation of the Feed Ban in the EU Berne, 2010 TAFS

INTERNATIONAL FORUM FOR TRANSMISSIBLE ANIMAL DISEASES AND FOOD SAFETY a non-profit Swiss Foundation


http://madcowfeed.blogspot.com/2010/11/tafs1-position-paper-on-position-paper.html




Archive Number 20101206.4364 Published Date 06-DEC-2010 Subject PRO/AH/EDR> Prion disease update 2010 (11)

PRION DISEASE UPDATE 2010 (11)


http://www.promedmail.org/direct.php?id=20101206.4364




Monday, October 10, 2011

EFSA Journal 2011 The European Response to BSE: A Success Story

snip...

EFSA and the European Centre for Disease Prevention and Control (ECDC) recently delivered a scientific opinion on any possible epidemiological or molecular association between TSEs in animals and humans (EFSA Panel on Biological Hazards (BIOHAZ) and ECDC, 2011). This opinion confirmed Classical BSE prions as the only TSE agents demonstrated to be zoonotic so far but the possibility that a small proportion of human cases so far classified as "sporadic" CJD are of zoonotic origin could not be excluded. Moreover, transmission experiments to non-human primates suggest that some TSE agents in addition to Classical BSE prions in cattle (namely L-type Atypical BSE, Classical BSE in sheep, transmissible mink encephalopathy (TME) and chronic wasting disease (CWD) agents) might have zoonotic potential.

snip...


http://www.efsa.europa.eu/en/efsajournal/pub/e991.htm?emt=1


http://www.efsa.europa.eu/en/efsajournal/doc/e991.pdf





see follow-up here about North America BSE Mad Cow TSE prion risk factors, and the ever emerging strains of Transmissible Spongiform Encephalopathy in many species here in the USA, including humans.


Transmissible Spongiform Encephalopathy (TSE) Prion Disease, aka mad cow disease, are emerging in more ways than one, and the risk factors there from are very disturbing. The TSE Prion disease has morphed into many different strains, and in some cases, with Co-occurrence of multiple Prion Protein Types in one recipient. There are now many more strains of BSE aka Mad Cow Disease, what are termed 'atypical' BSE. atypical BSE is more virulent than the typical UK c-BSE. L-BSE, H-BSE, along with the U.K. C-BSE, have all been documented in North America (IBNC prion disease in cattle has not been documented in North America to date), along with two different strains of Chronic Wasting Disease (CWD) in deer and elk (documented to date), and many typical strains of Scrapie in sheep and goat, with the atypical Nor-98 Scrapie documented and spreading in North America. Over time, all these different TSE prion disease have been rendered and fed back to food producing animals here in the USA. The August 4, 1997 partial and voluntary mad cow feed ban in the USA was nothing more than ink on paper. The Bovine Spongiform Encephalopathy (BSE) aka mad cow disease surveillance program of the USA was terrible flawed (see GAO, OIG reports), and the BSE testing program was just as flawed, and this all a proven fact. With the mad cow feed ban having not been enforceable, 100s and 100s of TONS of banned MBM went on to be fed to USA cattle a decade after the August 4, 1997 partial and voluntary feed ban for BSE was inked on paper. Today, the USA has no idea (in my opinion), just how bad the BSE aka mad cow disease really is. However, the USA has more documented TSE prion disease in different species in the wild, than any other country, all rendered and fed back to food producing animals for man and animal. sporadic Creutzfeldt Jakob Disease in humans, with unknown pathology is rising in the USA and Canada. I urge Science to move forward, leaving the politics behind $$$

Monday, October 10, 2011 EFSA Journal 2011

The European Response to BSE: A Success Story


http://transmissiblespongiformencephalopathy.blogspot.com/2011/10/efsa-journal-2011-european-response-to.html





Monday, September 26, 2011

L-BSE BASE prion and atypical sporadic CJD


http://bse-atypical.blogspot.com/2011/09/l-bse-base-prion-and-atypical-sporadic.html



Saturday, June 25, 2011

Transmissibility of BSE-L and Cattle-Adapted TME Prion Strain to Cynomolgus Macaque

"BSE-L in North America may have existed for decades"


http://transmissiblespongiformencephalopathy.blogspot.com/2011/06/transmissibility-of-bse-l-and-cattle.html



Over the next 8-10 weeks, approximately 40% of all the adult mink on the farm died from TME.

snip...

The rancher was a ''dead stock'' feeder using mostly (>95%) downer or dead dairy cattle...


http://web.archive.org/web/20030516051623/http://www.bseinquiry.gov.uk/files/mb/m09/tab05.pdf




Sunday, June 26, 2011

Risk Analysis of Low-Dose Prion Exposures in Cynomolgus Macaque


http://transmissiblespongiformencephalopathy.blogspot.com/2011/06/risk-analysis-of-low-dose-prion.html



PRICE OF MAD COW TSE PRION POKER GOES UP $$$

Saturday, December 3, 2011

Isolation of Prion with BSE Properties from Farmed Goat

Volume 17, Number 12—December 2011


http://transmissiblespongiformencephalopathy.blogspot.com/2011/12/isolation-of-prion-with-bse-properties.html



Saturday, November 19, 2011

Novel Prion Protein in BSE-affected Cattle, Switzerland


http://transmissiblespongiformencephalopathy.blogspot.com/2011/11/novel-prion-protein-in-bse-affected.html


Friday, October 28, 2011

CVM Issues Animal Feed Safety System (AFSS) (BSE) Overview October 28 2011

CVM Issues Animal Feed Safety System (AFSS) Overview

Document -

snip...

Historically, FDA’s feed program has focused on specific safety issues, such as unsafe tissue residues resulting from feeding of medicated feeds, Bovine Spongiform Encephalopathy (BSE), and Salmonella, but has not addressed feed safety in a comprehensive manner. A comprehensive feed safety program is intended to help identify feed hazards and their potential sources and to enable establishments and FDA to prevent or eliminate the occurrence of unacceptable feed risks from those hazards.

snip...


http://www.fda.gov/downloads/AnimalVeterinary/SafetyHealth/AnimalFeedSafetySystemAFSS/UCM277673.pdf



i about choked when i read about the _historically_ part. in truth, FDA historically failed in the BSE mad cow protein feed ban and SRM removal, along with the BSE surveillance program.


strange, i wrote and sent this off earlier today. ...tss


----- Original Message -----

From: Terry S. Singeltary Sr.

To: stephanie.yao@fda.hhs.gov

Sent: Friday, October 28, 2011 1:35 PM

Subject: BSE AKA MAD COW FEED ENFORCEMENT ACTIVITIES reports ???

Hello Ms. Yao Ma'am and FDA et al,

A kind and warm greetings from Bacliff, Texas.

I have been following the mad cow saga here in the USA, pretty much since it started here in the USA. I lost my mother to the Heidenhain Variant of Creutzfeldt Jakob Disease, an exceedingly rare strain of the sporadic CJD's. as a layperson, i never accepted the myth that 85%+ of all human TSE i.e. the sporadic CJD was just a happenstance of bad luck, a spontaneous happening, no source, no route. just bad luck. i am sorry, i just could never accept that.

anyway Ma'am, I am wondering why there have been NO reports on the Enforcement Activities to Limit the Spread of BSE since January 12, 2011 ?


http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/BovineSpongiformEncephalopathy/ucm117662.htm



SNIP...

SEE FULL TEXT ;


http://madcowfeed.blogspot.com/2011/10/cvm-issues-animal-feed-safety-system.html



Monday, April 12, 2010

Senator Kay Bailey Hutchison says NO to safer food and S. 510 FDA Food Safety Modernization Act of 2009


http://fdafailedus.blogspot.com/2010/04/senator-kay-bailey-hutchison-says-no-to.html



http://transmissiblespongiformencephalopathy.blogspot.com/


http://creutzfeldt-jakob-disease.blogspot.com/


http://bseusa.blogspot.com/



http://bse-atypical.blogspot.com/


http://madcowusda.blogspot.com/



http://chronic-wasting-disease.blogspot.com/



http://nor-98.blogspot.com/



http://scrapie-usa.blogspot.com/




http://fdafailedus.blogspot.com/




TSS