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

Food safety for whom? Corporate wealth versus people's health

Food safety for whom? Corporate wealth versus people's health

GRAIN, May 2011

snip...

School children in the US were served 200,000 kilos of meat contaminated with a deadly antibiotic-resistant bacteria before the nation's second largest meat packer issued a recall in 2009. A year earlier, six babies died and 300,000 others got horribly sick with kidney problems in China when one of the country's top dairy producers knowingly allowed an industrial chemical into its milk supply. Across the world, people are getting sick and dying from food like never before. Governments and corporations are responding with all kinds of rules and regulations, but few have anything to do with public health. The trade agreements, laws and private standards used to impose their version of "food safety" only entrench corporate food systems that make us sick and devastate those that truly feed and care for people, those based on biodiversity, traditional knowledge, and local markets. People are resisting, whether its movements against GMOs in Benin and "mad cow" beef in Korea or campaigns to defend street hawkers in India and raw milk in Colombia. The question of who defines "food safety" is increasingly central to the struggle over the future of food and agriculture.

The growing global menace

Food should be a source of health, not harm. But food can maim, cripple, and kill. The leading cause of food poisoning in the United Kingdom today is Campylobacter, a tiny bacterium, rife throughout the country's chicken supply, that causes in humans diarrhoea, fever, abdominal pain and cramping, and in some cases chronic, even life-threatening, conditions. People get it from touching raw poultry or eating undercooked birds. Some 85% of the chicken population in the UK may be infected. In the United States, the top culprits these days are Norovirus, mostly transmitted from dirty hands, and Salmonella, contracted from eating food with faeces on it. Norovirus will give you acute vomiting and diarrhoea, while Salmonella causes vomiting, fever and cramps

snip...

Graph: Data compiled by GRAIN from government and UN sources, 2008-2010 (except Australia=2005)

Among the more notorious food safety incidents in recent years was the melamine scandal in China in 2008. Six babies died and 300,000 others got horribly sick with kidney problems when the industrial chemical melamine got into the commercial milk distribution circuit. There was also a dioxin scandal in Germany in January 2011, where the German authorities shut down more than 4,000 farms after it was discovered that a German company had sold 200,000 tonnes of dioxin-tainted animal feed, which had subsequently entered the food chain. Dioxins are cancer-causing poisons formed in the burning of waste and other industrial processes. 1

How bad is the problem globally? Believe it or not, there are no global statistics or tracking mechanisms on food safety incidents worldwide; reliable data on their frequency and impact are grossly inadequate. Nevertheless, the available data do show that food poisoning is quite common in most countries (see Graph 1). 2 According to the Singaporean authorities, who run a pretty tight food hygiene system, roughly 1.5 billion people worldwide are affected by food-borne disease outbreaks each year, resulting in 3 million deaths. 3

The price of this food safety mess is huge. The UK puts the annual costs to the British economy at US$1.92 billion, which its Food Standards Agency bluntly calls "too much". Australia's annual bill is US$1.23 billion. The World Health Organisation says that the annual cost to Vietnam is US$210 million. In the US, the Centers for Disease Control (CDC) has long given the figure of US$35 million per year, but a new study released by the Pew Charitable Trusts at Georgetown University in 2010 puts the figure astronomically higher, at US$152 billion. 4

Food safety in the Fast Food Nation

Does US-style production represent the future of global food? Possibly. Certainly, elite Western opinion shapers and policymakers – the editors of The Economist, the directors of the Bill and Melinda Gates Foundation, certain key elements in the Obama administration – think it should. So it is worthwhile to consider how the US food safety regime has responded to the dilemmas of scale in recent years.

In an industrialised, highly consolidated food system geared to maximising profit by selling vast volumes of cheap food, pressure exists at every phase of the production chain to cut costs by cutting corners, including safe food practices. Moreover, the very scale of modern food production means that seemingly isolated lapses can become quite grave, subjecting millions of people to danger based on the actions of a single production facility.

The case of Peanut Corp. of America demonstrates the perils of scale. Until recently, the company ran two plants: one in Texas, one in Georgia. These two facilities processed 2.5% of the peanuts produced in the United States, and sold "peanut paste" to the entire US processed food industry. By late 2007, the company had evidently given up trying to maintain hygienic conditions at its facilities. In late 2008, people started coming down with salmonella from a dizzying array of products containing Peanut Corp.'s paste, prompting the FDA to initiate a "voluntary recall". By the time all was said and done, the recall affected no fewer than 1,800 supermarket brands. The tainted products killed nine people and officially sickened around 700 – half of them children – in 46 US states. The Centers for Disease Control (CDC) reckons that for every reported case of salmonella, another 38 cases go unreported – so the real number of people made ill from the output of just two facilities may be up to 26,000. In the wake of the fiasco, US journalists showed that the FDA had "outsourced" inspection of the Georgia plant to state authorities, and then ignored the state inspectors' findings of atrocious hygiene practices. Moreover, it turned out that the company's own testing had found salmonella in huge batches of peanut paste, which it proceeded to send out anyway. i

In another incident in 2009, a company called Beef Packers, owned by transnational agribusiness giant Cargill, had to declare two "voluntary recalls" involving over 500 tonnes of ground beef infected with antibiotic-resistant salmonella. ii The USDA announced that consuming the suspect meat could cause "treatment failure" iii – that is, death – because of its ability to withstand drugs. At least 39 people in 11 states reported getting sick, and more than 200,000 thousand kilos of the tainted meat was served to school children through the National School Lunch program. iv

The official response to such incidents has been minimal. In January 2011, a hotly debated piece of legislation called the Food Safety Modernisation Act was signed into being. The intention of the original Bill was to update and inject some resources into the US food safety system. It basically called for more inspections, gave the government authority to mandate food recalls, and provided some traceability to an otherwise fairly unregulated industrial sector. Who would oppose such a move? The fat cats from the food industry, you might think – the Cargills and the Tysons, who don't want to be controlled. But you would be wrong. The new rules would hardly affect them.

According to an analysis by the US NGO Food & Water Watch, nothing in the Act would have prevented the Peanut Company of America from sending out its tainted paste. Worse, the rules would not even touch the meat sector, the biggest source of food-borne illness in the United States. v The main opponents of the bill throughout the debate were small family farm activists who, because of the way the bill was framed, saw themselves falling under these controls when they are not the problem. So instead of instigating real food safety reform in a country where one out of four people gets sick and 5,000 people die from eating contaminated food each year, the law might do next to nothing.

In the absence of stricter public action around food safety, corporations have moved to fill the void -- sometimes to tragicomic effect. A case in point: in the mid-2000s, a company called Beef Products Inc. had an ingenious idea: it would buy slaughterhouse scraps – which are extremely likely to be infected by bacterial pathogens – from large-scale beef processors at cut-rate prices. It would purée those parts into a paste, which it would then mix with ammonia to kill bacterial pathogens. It would sell the product back the the beef industry as a cheap filler for ground beef, with the added feature that the ammonia in the paste would sterilise the ground beef it was mixed with. The beef industry had found a "solution" to the problem of bacterial pathogens in ground beef! The product, known in the industry as "pink slime" for its distinctive look, could be found in 70% of hamburgers consumed in the United States by the end of the decade. The USDA's Food Safety Inspection Service, which oversees meat safety, applauded -- it recognised "pink slime" as safe without requiring testing, on the grounds that it had been sterilised by ammonia. But in 2009, a New York Times exposé found that pink slime in fact tended to be ridden with pathogens -- and was actively adding to the pathogen load of the ground beef it was mixed with. Beef Products Inc. responded by merely upping the ammonia dose for its mix. To this day, the product remains widely used in the vast US ground beef market, including at fast-food chains nationwide. vi

If the official US response to highly visible manifestations of food poisoning, like Salmonella-tainted meat and peanut butter, has been underwhelming and industry-friendly, then the response to low-level exposure to pathogens that cause cumulative damage has been virtually non-existent. The first kind causes spectacular, impossible-to-ignore symptoms like vomiting and diarrhoea; the second entails subtle, easy-to-ignore ones that can cause significant long-term damage. Corporate-led food safety regimes like the one in the United States have to at least gesture at the first kind; the second kind, not so much.

It turns out that the USDA's Food Safety Inspection Service (FSIS), which oversees the safety of the US meat supply, routinely endorses meat that it knows to be tainted with residues of "veterinary drugs, pesticides, and heavy metals", the USDA Inspector General revealed in a 2010 report. vii The damning report was met with silence by the US media – probably because small amounts of substances like heavy metals don't cause dramatic immediate symptoms, but rather hard-to-trace, slow-to-develop conditions like cancer. As the report puts it, the "effects of residue are generally chronic as opposed to acute, which means that they will occur over time, as an individual consumes small traces of the residue". In its report, the USDA Inspector General's office expressed confidence that the FSIS would redouble efforts to keep heavy metals and antibiotic traces out of the meat supply going forward. Yet it had expressed the same thing, after exposing the same problem, in its report two years earlier. viii

Another example is the US Food and Drug Administration's refusal to act on mounting evidence that Bisphenol A, an industrial compound found in many food containers, is an endocrine disrupter. If the food safety regime for spectacular pathogens could be described as porous, that for the second, more subtle, kind barely exists at all.

Written with contributions from Tom Philpott, senior writer on food and agriculture for Grist magazine.

i "Peanut Corp. Shipped Product After Finding Salmonella", Bloomberg News, 27 January 2009, http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aeXwqlMnIWU0;
 and "Peanut Plant Had History of Health Lapses", New York Times, 26 January 2009, http://www.nytimes.com/2009/01/27/health/27peanuts.html?_r=1&ref=health


ii "Antibiotic-resistant salmonella, school lunches, and Cargill's dodgy California beef plant", Grist, 10 December 2010, http://www.grist.org/article/2009-12-10-meat-wagon-cargill-salmonella/


iii "California Firm Recalls Ground Beef Products Due to Possible Salmonella Contamination", USDA Food Safety and Inspection Service, 9 December 2009,

http://www.fsis.usda.gov/News_&_Events/Recall_065_2009_Release/index.asp


iv "Why a recall of tainted beef didn't include school lunches", USA Today, 2 December 2009, http://www.usatoday.com/news/education/2009-12-01-beef-recall-lunches_N.htm


v Responsibility for food safety in the US is divided between two agencies. The US Department of Agriculture is responsible for meat, poultry and egg products, which accounts for 20% of the US food supply. The Food and Drug Administration, within the US Department of Health, takes care of the rest. The Food Safety Modernisation Act addresses only the work of the FDA. The top sources of food poisoning in the United States are, however, poultry, beef and leafy vegetables (in that order, 2007). See: "Can Congress make a food-safety omelette without breaking the wrong eggs? ", Grist, 25 October 2010.

vi "Safety of Beef Processing Method Is Questioned", New York Times, 30 December 2009,

http://www.nytimes.com/2009/12/31/us/31meat.html?_r=1&partner=rss&emc=rss&pagewanted=all
; See also, "Lessons on the food system from the ammonia-hamburger fiasco", Grist, 5 January 2010, http://www.grist.org/article/2010-01-05-cheap-food-ammonia-burgers


vii "FSIS National Residue Program for Cattle", Office of the Inspector General, US Department of Agriculture, http://www.usda.gov/oig/webdocs/24601-08-KC.pdf



viii "USDA Inspector General: meat supply routinely tainted with harmful residues", Grist, 15 April 2010: http://www.grist.org/


This is "food safety"?

Government and industry action on food safety gives little indication that they recognise any fundamental problem with industrial food production. Rarely do their regulations or standards hinder corporate practices in any significant way. On the contrary, they tend to reinforce the power of large industry while undermining, or even criminalising, small-scale production and local food cultures. Colombia, for instance, is in the process of implementing legislation to prevent the sale of raw milk in urban areas. Well over two million farmers and vendors depend for their livelihoods on these sales of raw milk, and around 20 million Colombians, most of them poor, depend on raw milk as an affordable and essential source of nutrition, easily made safe by boiling it at home. Hard pressed to justify its moves on public health grounds, the government says that the legislation is part of its commitment to the WTO, and that it will help to "modernise" the dairy sector, making it better able to compete with imports when a looming free trade agreement with the EU kicks in. 5

These days, in Colombia and elsewhere, "food safety" policy has little to do with public health or consumers. It has become a battleground among contesting interests, the site of power struggles for control over food and agriculture, with decisions being increasingly taken far from producers and consumers, in the obscure world of trade negotiations and multilateral agencies, where politics and commerce, not science and public health, are what drive things.

Consider the case of bovine spongiform encephalopathy (BSE), the fatal brain-wasting condition popularly known as mad cow disease. People get the human strain of it by eating the meat of cows that have been fed diseased animals as a cheap source of protein – a practice common in industrial feedlots since the 1970s. The US and Canada lost Japan, Korea and several other major export markets for beef when BSE was found in their herds in 2003, and have had a tough time regaining those markets because risks remain from their industries' feeding practices. 6 Indeed, in March 2011, a new case of BSE was identified in a Canadian cow. 7 But through constant pressure, particularly at the trade negotiating table, both countries have secured some concessions to allow certain parts of the cow, or the meat of younger animals, to cross borders freely. Both countries also went to the Organisation for Animal Health (OIE) in Paris, which has a similar role to Codex Alimentarius Commission in Rome but for the animal kingdom, to get their beef declared generally safe for consumption. Where does that leave Japan? Unmoved. It says that its standards are higher than those of the OIE or the US, and have to be given priority.

Beijing, for its part, has so far refused to budge. But that doesn't mean that Chinese consumers are getting ractopamine-free pork. The same government fighting off ractopamine-laced US pork, is aggressively pushing, in the name of "food safety", a consolidation and modernisation of the country's pig production based on the US factory farm model. China's two largest, vertically-integrated pork producers, Yurun and Shineway, both of whom have been heavily funded by the US bank Goldman Sachs, were implicated in recent food safety incidents involving ractopamine and clenbuterol (another banned drug added to pig feed for the same purposes). 8 In March 2011, Chinese consumers were shocked when a CCTV television report uncovered how ractopamine and clenbuterol are widely used in the farms supplying Shineway in Henan Province. 9 The report found that Shineway was actually offering farmers higher prices for pigs fed ractopamine. 10

Superbugs and megafarms

"Superbug" is a term used to describe bacteria that have acquired the ability to resist commonly used antibiotics. One of the most notorious is Methicillin-resistant Staphylococcus aureus (MRSA), which emerged in the 1960s in the UK and has since spread around the world, with deadly consequences. In the US alone, 17,000 people died from MRSA infection in 2005. i

MRSA is typically associated with hospitals, where the superbug has a tendency to get into open wounds and cause difficult-to-heal infections. But in recent years these superbugs have found another place to thrive: industrial pig farms. ii

In 2004, Dutch researchers identified a new strain of MRSA, later labelled ST398 or "pig MRSA", which they found in people in close contact with Dutch pig farms. Within two years ST398 become a leading source of human MRSA infection in the country, accounting for more than one in five human MRSA cases. Studies showed that these cases were closely related with pigs, and further research revealed that ST398 was running rampant in pigs on Dutch farms. A 2007 survey found ST398 in 39% of pigs and 81% of local piggeries. iii

New surveys of farms outside of the Netherlands have turned up similar numbers. iv The first ever EU-wide survey for MRSA on pig farms in 2009, using a method that "largely underestimates MRSA prevalence", found ST398 in more than two-thirds of EU member states. Spain and Germany had the highest incidence, with over 40% of pig holdings testing positive for MRSA. v Not surprisingly, given the European pig industry's heavy exports overseas, ST398 is turning up in pigs beyond Europe's borders, too. A study of pigs in the Canadian province of Ontario, for instance, found ST398 in a quarter of local pigs, as well as in one-fifth of the pig farmers tested. vi Only one study has been conducted in the US so far: it was a pilot study of two large hog operations in the midwest that found ST398 in 49% of the pigs and 45% of the workers. vii

MRSA has the potential to evolve in very dangerous ways in its new home on pig farms. The density of animals in factory farms allows the bacteria to evolve rapidly and in diverse ways. Also, the use of antibiotics on factory farms is ubiquitous. Pigs are routinely fed antibiotics in their feed and water, often as a preventive measure against disease outbreaks and even simply to increase growth rates.

In the US, 80% of all antibiotics consumed annually are consumed by livestock. viii In China, the figure is nearly 50%. ix Even in the EU, where the non-therapeutic use of antibiotics for animals is banned and where the types of antibiotics allowed for livestock are controlled, the use of antibiotics for animals still exceeds their use for humans. In Germany, for example, three times as many antibiotics are given to animals as to humans. x Such widespread use of antibiotics in factory farms speeds up the development of antibiotic resistance among bacteria. Unlike other strains of MRSA, ST398 can already withstand tetracyclines, a group of antibiotics that is given heavily and regularly to pigs in factory farms. The medical profession is getting increasingly worried about what this will mean for the future of human health care, as antibiotics may become useless. The WHO now calls it "the greatest threat to human health". xi

The good news, however, is that ST398 still hasn't shown much virulence in humans, nor is it easily transmitted between people. Not yet, at least.

In 2010, a 14-year-old girl in France, recovering in hospital from pneumonia, was infected with a superbug. She soon began having serious respiratory problems, her lungs started bleeding, and within six days she died. The superbug that killed her was a clone of MRSA ST398 that is known to circulate in humans. The most alarming issue for the French doctors studying the case was that this was the first incident on record in which this strain of MRSA had acquired the capacity to produce a lethal toxin in humans, something that certain other strains of superbugs are able to do. They reasoned that if the clone of MRSA ST398 could do it, then surely "pig MRSA" has the same capacity. xii

It is not much of a stretch to imagine a situation where "pig MRSA" passes from a pig to a farm worker carrying another MRSA strain with virulence to humans, mixes with that strain, and acquires its capacity for virulence. The new virulent strain of ST398 could then easily pass back into the pigs, where it would rapidly amplify and spread. ST398 is transmitted to humans not only through contact with live pigs: the bacteria is also present on meat sold in supermarkets and can be carried over large distances by the insects that pass in and out of farms. xiii

The EU is slowly starting to take action to defend against such a possibility. It has implemented several measures to restrict the use of antibiotics in livestock production and, at national and at EU level, some surveillance of farms is being carried out. In 2009, a panel of the European Food Safety Authority recommended that the EU move towards "systematic surveillance and monitoring of MRSA in intensively reared animals". South Korea, for its part, banned the use of seven antibiotics in animal feed in 2008, and implemented a national programme to reduce the use of antibiotics on livestock farms. But such restrictions on the use of antibiotics for livestock hardly exist in the US, although proposed legislation restricting the non-therapeutic use of certain antibiotics in feed is currently before Congress. As for surveillance, the US National Antimicrobial Resistance Monitoring System doesn't even test for MRSA. xiv Outside the industrialised countries, where the meat industry is expanding most rapidly, there is an almost complete absence of controls on the use of antibiotics in agriculture and of surveillance for pathogens such as MRSA.

Enhancing surveillance and cutting back on the use of antibiotics in factory farms are important measures. But they aren't enough to deal effectively with the threat posed by MRSA and the myriad other pathogens that thrive in factory farms. A staggering 61% of all human pathogens, and 75% of new human pathogens, are transmitted by animals, with many of the most dangerous – such as bird flu, BSE, swine flu and the Nypah virus – having emerged from intensive livestock farms. xv It is the way that animals are farmed that is fundamentally at issue. xvi

i E. Klein, D.L. Smith, R. Laxminarayan, "Hospitalizations and Deaths Caused by Methicillin-Resistant Staphylococcus aureus, United States, 1999–2005", Emerg. Infect. Dis. Vol. 13, No. 12, 2007, pp. 1840–46.

ii Ed Yong, "MRSA in pigs and pig farmers", 23 January 2009,

http://scienceblogs.com/notrocketscience/2009/01/mrsa_in_pigs_and_pig_farmers.php


iii X.W. Huijsdens et al., "Community-acquired MRSA and pig-farming", Ann. Clin. Microbiol. Antimicrob., Vol. 5, No. 26, 2006; A.J. de Neeling et al., "High prevalence of methicillin resistant Staphylococcus aureus in pigs", Vet. Microbiol., Vol. 122, No. 3–4, 21 June 2007, pp. 366–72; I. van Loo et al., "Emergence of methicillin-resistant Staphylococcus aureus of animal origin in humans", Emerg. Infect. Dis., Vol. 13, No. 12, 2007, pp. 1834–9.

iv Danish Integrated Antimicrobial Resistance Monitoring and Research Programme, http://www.danmap.org/pdfFiles/Danmap_2009.pdf


v "Pig MRSA widespread in Europe", Ecologist, 25 November 2009; Broens et al., "Diagnostic validity of pooling environmental samples to determine the status of sow-herds for the presence of methicillin-resistant Staphylococcus aureus (MRSA)", Poster presented at the ASM–ESCMID Conference on Methicillin-resistant Staphylococci, in Animals: Veterinary and Public Health Implications, London, 2009.

vi "Guelph Researchers Find MRSA in Pigs", University of Guelph, 8 November 2007, http://www.uoguelph.ca/news/2007/11/post_75.html.


vii T.C. Smith, M.J. Male, A.L. Harper, J.S. Kroeger, G.P. Tinkler et al., (2009) "Methicillin-Resistant Staphylococcus aureus (MRSA) Strain ST398 Is Present in Midwestern US Swine and Swine Workers", PLoS ONE, Vol. 4, No. 1, 2009.

viii See "New FDA Numbers Reveal Food Animals Consume Lion's Share of Antibiotics", Center for a Liveable Future, Johns Hopkins University, 23 December 2010,. http://www.livablefutureblog.com/2010/12/new-fda-numbers-reveal-food-animals-consume-lion%E2%80%99s-share-of-antibiotics
 See also Margaret Mellon, Charles Benbrook, Karen Lutz Benbrook, "Hogging it!: Estimates of antimicrobial abuse in Livestock", Union of Concerned Scientists, 2001, http://www.ucsusa.org/



ix "Half of China's antibiotics fed to animals: expert", Xinhua, 26 November 2010.


x Kristen Kerksiek, "Farming out Antibiotics: The fast track to the post-antibiotic era", Infection Research, Germany, 22 March 2010,


http://www.infectionresearch.de/perspectives/detail/pressrelease/farming_out_antibiotics_the_fast_track_to_the_post_antibiotic_era/



xi AAP, "Greatest threat to human health", Sydney Morning Herald, 16 February 2011, http://www.smh.com.au/lifestyle/wellbeing/greatest-threat-to-human-health-20110216-1awai.html


xii Frédéric Laurent, "Les souches de staphylococcus aureus ST398 sont-elles virulents", Bull. Acad. Vét. France, Vol. 163, No. 3, May 2010.

xiii See Aqeel Ahmad et al., "Insects in confined swine operations carry a large antibiotic resistant and potentially virulent enterococcal community", BMC Microbiology, 2011, http://www.biomedcentral.com/1471-2180/11/23/abstract


xiv Maryn McKenna, "Alarm over 'pig MRSA' – but not in the US", Wired, 30 October 2010, http://www.wired.com/wiredscience/2010/10/alarm-over-pig-mrsa-%E2%80%94-but-not-in-the-us/


xv John McDermott and Delia Grace, "Agriculture-Associated diseases: Adapting Agriculture to improve Human Health", ILRI, February 2011.

xvi GRAIN, "Germ warfare: Livestock disease, public health and the military-industrial complex", Seedling, January 2008, http://www.grain.org/seedling/?id=533


Food safety and global trade: Europe and the US impose their standards


snip...SEE FULL TEXT REPORT HERE ;


http://www.grain.org/briefings/?id=222


Read the synopsis of this report here.

http://www.grain.org/m/?id=327


http://www.grain.org/front_files/GRAIN_Food_Safety_Synopsis_2011.pdf


Approximately 50.3 million pounds of the beef recalled by HallmarkWestland went to federal nutrition programs, including the National School Lunch Program, and of those 50.3 million pounds, about 19.6 million pounds had already been consumed at the time the recall was issued. Release No. 0054.08, USDA, Transcript of Technical Briefing - HallmarkWestland Meat Packing Company (Feb. 21, 2008).

9. HSUS members that consume meat products, including beef products, are concerned about eating adulterated meat products and the health risks associated with such adulterated meat. Specifically, they are concerned that downed cattle are at an increased risk for harboring and transmitting BSE prions and other pathogens. The consumption of meat products derived from BSE-infected cattle is believed to cause a human neurological disease known as variant Creutzfeldt-Jakob disease ("vCJD"). The disease is progressive, invariably fatal, and there is no known effective treatment or cure. Downed cattle may also be at higher risk for harboring other foodborne transmissible pathogens, including E. coli 0157:H7, Salmonella, and anthrax. By allowing downed cattle to enter the food supply, USDA's regulatory loophole injures members of The HSUS by placing them at an increased risk of contracting these food-borne illnesses each time they eat beef.

10. Members of The HSUS are also concerned about the meat products provided to their children through the National School Lunch Program. More than 31 million school children receive lunches through the program each school day. To assist states in providing healthful, low-cost or free meals, USDA provides states with various commodities including ground beef.

As evidenced by the HallmarkWestland investigation and recall, the potential for downed animals to make their way into the National School Lunch Program is neither speculative nor hypothetical.

http://biotech.law.lsu.edu/cases/FDA/hsus-v-schafer-usda-complaint.pdf


Sunday, May 01, 2011

STUDY OF ATYPICAL BSE 2010 Annual Report May 2011

http://bse-atypical.blogspot.com/2011/05/study-of-atypical-bse-2010-annual.html


Monday, April 18, 2011

Multidrug-Resistant Staphylococcus aureus in US Meat and Poultry

http://staphmrsa.blogspot.com/2011/04/multidrug-resistant-staphylococcus.html



TSS