Center for Veterinary Medicine Fiscal Year 2007 Annual Report

THE CENTER FOR VETERINARY MEDICINE

ANNUAL REPORT

Fiscal Year 2006: October 1, 2006–September 30, 2007

Contents

snip...

CONTROLLING RISK FROM BSE

THE CHALLENGE

BSE is a chronic, degenerative, always fatal neurological disease affecting the central nervous system of cattle. BSE belongs to a family of diseases known as transmissible spongiform encephalopathies (TSEs) that include several ruminant and nonruminant animal diseases. Laboratory and epidemiological evidence strongly suggests that people can contract a human TSE, variant Cruetzfeldt-Jakob Disease, by consuming food from BSE-infected cattle. In the absence of adequate controls, BSE could spread among the cattle population through feed ingredients derived from infected cattle.

FY 2007 CHALLENGES

We continued to provide the expert scientific knowledge and review on BSE for the Agency. Much of our effort during the year focused on enforcing and strengthening our BSE feed regulation, which prohibits the use of certain mammalian-origin proteins in ruminant feed. The purpose is to prevent the establishment and amplification of BSE in the United States through feed. Following are highlights of some of our achievements that accomplished FDA’s strategic goal of consumer protection and the Department-wide objective of improving the safety of food products.

U.S. BSE RISK STATUS

Unlike the several previous fiscal years, FY 2007 did not see the discovery of any BSE-infected cattle in the United States. Due in part to the work of CVM staff, the United States in 2007 achieved controlled-risk status through the OIE (World Organization for Animal Health). Although this category requires presentation of an international veterinary certificate attesting that certain conditions have been complied with, the status is an improvement from a trade standpoint over the previous status of “undetermined.”

TRAINING, EDUCATION, AND ENFORCEMENT

Education for the Regulated Industry

During the fiscal year, CVM released a video,” Preventing the Spread of BSE,” on FDA’s Web site at http://www.fda.gov/cvm/bseOtherInfo.htm. The approximately 11-minute video is intended to help truckers prevent the spread of BSE. The video explains the requirements under FDA’s BSE feed regulation that truckers clean out their trucks to prevent cross-contamination when carrying materials prohibited for use in the feed of ruminants. We developed the video in cooperation with FDA’s Office of Regulatory Affairs, the American Feed Industry Association, the National Grain and Feed Association, and the National Renderers Association.

Inspections

To implement the goal of improving the safety of food products through better manufacturing and product oversight, through the FY 2007 work-planning process we allocated field resources to allow for targeted inspections of all known renderers and feed mills processing products containing prohibited materials (approximately 500 high-risk firms). We estimate that the total number of FY 2007 BSE-related inspections of all firms that process or handle animal feed – including inspections both by state and FDA investigators – will approximate the confirmed number for FY 2006, which was 8,934.

We added a new inspectional emphasis in FY 2007 – targeted BSE inspections of the animal feed transportation industry. The transportation industry is a critical element in the promotion of animal feed safety through the prevention of cross-contamination. We issued an assignment to the FDA Districts to identify transportation firms and to conduct transporter inspections, and we made significant revisions to the inspection checklist by adding transportation questions.

During FY 2007, the Agency conducted BSE inspections at far more than 1,000 firms marked “transporter/hauler” on the BSE checklist. Although most of these inspections were done at firms/sites that also fit other categories on the checklist (such as feed mills, renderers, and distributor/retailers), the increased focus on transportation by these firms will provide public health benefit as well.

Enforcement Actions

Although inspections show that the rate of violations of the BSE feed rule remain low, violations may lead to enforcement actions. For example, during the year an Ohio renderer of bovine and poultry materials and two of its officers entered into a consent decree of permanent injunction due to continuing, significant violations of FDA’s ruminant feed ban. The defendants agreed to come into compliance with the regulations including labeling products with the statement “Do not feed to cattle or other ruminants,” maintaining separate lines of equipment for producing various products, and/or sufficiently cleaning existing equipment between uses. Further, the consent decree provides for FDA to require a recall or shutdown in the event of future violations.

Field Training

CVM staff conducted 9 BSE feed regulation training sessions, ranging from 2-hour updates to 2-day comprehensive training, for FDA field staff and state regulators.

STRENGTHENING THE BSE FEED REGULATION

During the year, CVM completed work on a final rule that would amend the BSE feed rule regulation to remove the highest risk tissue from all animal feed to prevent the spread of BSE. In addition, the revisions would augment the current animal feed regulation by further reducing the risks of BSE associated with cross-contamination and on-farm mis-feeding. Responding to comments on the proposed rule issued in October 2005, we have conducted a new economic analysis and revised our environmental assessment, focusing in both instances on carcass disposal.

DEVELOPING ANALYTICAL METHODS FOR DETECTING PROHIBITED PROTEINS

Because of changing demands on the FDA field laboratories, the validation of the real time polymerase chain reaction method for detecting prohibited animal proteins in animal feed was not completed this year. However, the information needed for validation was collected from the participating laboratories, and the data are currently being analyzed. When it is validated, the method will detect prohibited proteins produced according to U.S. processing conditions. CVM’s Office of Research during the year validated the real time polymerase chain reaction method for use in detecting prohibited proteins (bovine, ovine, and porcine materials) processed according to European Union conditions. Thus, the method can be used to detect prohibited materials in imported products.

AVOIDING UNSAFE DRUG RESIDUES IN HUMAN FOOD

THE CHALLENGE

Improper use of approved drugs or use of unapproved drugs in domestic animals can result in unsafe residues in meat, poultry, seafood, and milk. Firms or individuals that repeatedly present animals for slaughter that are adulterated with illegal drug residues – identified through the USDA’s National Drug Residue Monitoring Program – may cause a significant public health concern. In fact, investigation of repeat violators is a top priority. Investigating first-time violations of residues from drugs prohibited from extralabel use in food animals, residues of drugs not approved for food animal use, and very high-level drug residues are also high priorities.

FY 2007 ACCOMPLISHMENTS

ENSURING FEED SAFETY

THE CHALLENGE

Threats to the safety of the Nation’s animal feed supply could come from several sources. Contaminants and unsafe additives in animal feed can harm the animals, as well as humans who consume animal products, and can adversely affect the Nation’s food and feed supplies. Improper manufacture of animal feeds can also result in health problems for animals and humans.

FY 2007 ACCOMPLISHMENTS

APPENDIX C

CVM* 2007 HONOR AWARD RECIPIENTS

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http://www.fda.gov/cvm/FY2007AnnualReport.htm#CONTROLLING%20RISK%20FROM%20BSE

2007

10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. MBM IN COMMERCE USA 2007

Date: March 21, 2007 at 2:27 pm PST

REASON Blood meal used to make cattlefeed was recalled because it was cross-contaminated with prohibited bovinemeat 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

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

Wednesday, July 23, 2008

Audit says USDA lost track of imported cattle Report No. 50601-0012-Ch March 2008

http://usdameatexport.blogspot.com/2008/07/audit-says-usda-lost-track-of-imported.html

2008 Central Connecticut Cooperative Farmers Association 5/13/08 New England District Office Animal Protein Feed/Equine/Adulterated

http://www.accessdata.fda.gov/scripts/wlcfm/recentfiles.cfm

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

http://www.fsis.usda.gov/News_&_Events/Recall_021_2008_Release/index.asp

Texas Firm Recalls Cattle Heads That Contain Prohibited MaterialsRecall Release CLASS II RECALL FSIS-RC-020-2008 HEALTH RISK: LOW Congressional and Public Affairs (202) 720-9113 Peggy Riek WASHINGTON, June 26, 2008

http://www.fsis.usda.gov/News_&_Events/Recall_020_2008_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, May 27, 2008 FDA BSE/Ruminant Feed Inspections Firms Inventory Report Texas Legend Ranch OAI 05/10/2008

http://madcowfeed.blogspot.com/2008/05/fda-bseruminant-feed-inspections-firms.html

SPECIFIED RISK MATERIALS SRMs

http://madcowspontaneousnot.blogspot.com/2008/02/specified-risk-materials-srm.html

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

http://madcowfeed.blogspot.com/

2006

Subject: MAD COW FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL,TN, AND WV

Date: September 6, 2006 at 7:58 am PST

snip...

see listings and references of enormous amounts of banned mad cowprotein 'in commerce' in 2006 and 2005 ;

see full text ; Friday, April 25, 2008 Substances Prohibited From Use in Animal Food or Feed [Docket No. 2002N-0273] (Formerly Docket No. 02N-0273) RIN 0910-AF46

http://madcowfeed.blogspot.com/2008/04/substances-prohibited-from-use-in.html

Monday, July 21, 2008 Massachusetts patient tested for mad cow disease Sunday, July 20, 2008 8:33 PM

http://cjdmadcowbaseoct2007.blogspot.com/2008/07/massachusetts-patient-tested-for-mad.html

Monday, July 21, 2008 Officials await tests on man for human Mad Cow Disease (Texas)

http://cjdtexas.blogspot.com/2008/07/officials-await-tests-on-man-for-human.html

CJD TEXAS (cjd clusters)

http://cjdtexas.blogspot.com/

BSE BASE MAD COW TESTING TEXAS, USA, AND CANADA

http://madcowtesting.blogspot.com/

MAD COW DISEASE terminology UK c-BSE (typical), atypical BSE H or L, and or Italian L-BASE

http://bse-atypical.blogspot.com/2008/03/mad-cow-disease-terminology-uk-c-bse.html

Wednesday, July 16, 2008

Implementation of 2008 Feed Ban Enhancements Questions and Answers July 15, 2008

http://madcowfeed.blogspot.com/2008/07/implementation-of-2008-feed-ban.html

Over the next 8-10 weeks, approximately 40% of all the adult mink on the farm died from TME. Since previous incidences of TME were associated with common or shared feeding practices, we obtained a careful history of feed ingredients used over the past 12-18 months. The rancher was a "dead stock" feeder using mostly (>95%) downer or dead dairy cattle and a few horses. Sheep had never been fed.

http://www.bseinquiry.gov.uk/files/mb/m09/tab05.pdf

USDA CERTIFIED DEAD STOCK DOWNER COW SCHOOL LUNCH PROGRAM

http://downercattle.blogspot.com/

Wednesday, July 16, 2008 Prevalence of the prion protein gene E211K variant in U.S. cattle Research Project:

Haplotype Structure of the Bovine Prion Gene Complex and Association with Bovine Spongiform Encephalopathy (Bse) Location: Animal Health Systems Research

Title: Prevalence of the prion gene E211K variant in U.S. cattle

http://bse-atypical.blogspot.com/2008/07/prevalence-of-prion-protein-gene-e211k.html

Docket APHIS-2006-0041 Docket Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived from Bovines Commodities Docket Type Rulemaking Document APHIS-2006-0041-0001 Document Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived From Bovines Public Submission APHIS-2006-0041-0006 Public Submission Title Comment from Terry S Singletary Sr Views Add Comments How To Comment

snip...

MY personal belief, since you ask, is that not only the Canadian border, but the USA border, and the Mexican border should be sealed up tighter than a drum for exporting there TSE tainted products, until a validated, 100% sensitive test is available, and all animals for human and animal consumption are tested. all we are doing is the exact same thing the UK did with there mad cow poisoning when they exported it all over the globe, all the while knowing what they were doing. this BSE MRR policy is nothing more than a legal tool to do just exactly what the UK did, thanks to the OIE and GW, it's legal now. and they executed Saddam for poisoning ???

go figure....

Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518

http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&d=APHIS-2006-0041-0006

ONE FINAL COMMENT PLEASE, (i know this is long Dr. Freas but please bear with me)

THE USA is in a most unique situation, one of unknown circumstances with human and animal TSE. THE USA has the most documented TSE in different species to date, with substrains growing in those species (BSE/BASE in cattle and CWD in deer and elk, there is evidence here with different strains), and we know that sheep scrapie has over 20 strains of the typical scrapie with atypical scrapie documented and also BSE is very likely to have passed to sheep. all of which have been rendered and fed back to animals for human and animal consumption, a frightening scenario. WE do not know the outcome, and to play with human life around the globe with the very likely TSE tainted blood from the USA, in my opinion is like playing Russian roulette, of long duration, with potential long and enduring consequences, of which once done, cannot be undone.

These are the facts as i have come to know through daily and extensive research of TSE over 9 years, since 12/14/97. I do not pretend to have all the answers, but i do know to continue to believe in the ukbsenvcjd only theory of transmission to humans of only this one strain from only this one TSE from only this one part of the globe, will only lead to further failures, and needless exposure to humans from all strains of TSE, and possibly many more needless deaths from TSE via a multitude of proven routes and sources via many studies with primates and rodents and other species. ...

Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518

snip... 48 pages...

http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8

bottom line, you don't look, you dont find, you don't report, you dont have, thus, you have this imaginary classification called the BSE MRR 'CONTROLLED RISK' ;-) NOT!

THE REALITY IS ;

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA)

Summary of the Scientific Report

The European Food Safety Authority and its Scientific Expert Working Group on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR) were asked by the European Commission (EC) to provide an up-to-date scientific report on the GBR in the United States of America, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in USA. This scientific report addresses the GBR of USA as assessed in 2004 based on data covering the period 1980-2003.

The BSE agent was probably imported into USA and could have reached domestic cattle in the middle of the eighties. These cattle imported in the mid eighties could have been rendered in the late eighties and therefore led to an internal challenge in the early nineties. It is possible that imported meat and bone meal (MBM) into the USA reached domestic cattle and leads to an internal challenge in the early nineties.

A processing risk developed in the late 80s/early 90s when cattle imports from BSE risk countries were slaughtered or died and were processed (partly) into feed, together with some imports of MBM. This risk continued to exist, and grew significantly in the mid 90's when domestic cattle, infected by imported MBM, reached processing. Given the low stability of the system, the risk increased over the years with continued imports of cattle and MBM from BSE risk countries.

EFSA concludes that the current GBR level of USA is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as there are no significant changes in rendering or feeding, the stability remains extremely/very unstable. Thus, the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent persistently increases.

http://www.efsa.europa.eu/en/science/tse_assessments/gbr_assessments/573.html

http://www.efsa.europa.eu/etc/medialib/efsa/science/tse_assessments/gbr_assessments/573.Par.0004.File.dat/sr03_biohaz02_usa_report_v2_en1.pdf

Please remember, the last two mad cows documented in the USA i.e. Alabama and Texas, both were of the 'atypical' BSE strain, and immediately after that, the USDA shut down the testing from 470,000 to 40,000 in the U.S. in 2007 out of about 35 million cattle slaughtered. also, science is showing that some of these atypical cases are more virulent to humans than the typical UK BSE strain ;

***Atypical forms of BSE have emerged which, although rare, appear to be more virulent than the classical BSE that causes vCJD.***

Progress Report from the National Prion Disease Pathology Surveillance Center

An Update from Stephen M. Sergay, MB, BCh & Pierluigi Gambetti, MD

April 3, 2008

http://www.aan.com/news/?event=read&article_id=4397&page=72.45.45

In this context, a word is in order about the US testing program. After the discovery of the first (imported) cow in 2003, the magnitude of testing was much increased, reaching a level of >400,000 tests in 2005 (Figure 4). Neither of the 2 more recently indigenously infected older animals with nonspecific clinical features would have been detected without such testing, and neither would have been identified as atypical without confirmatory Western blots. Despite these facts, surveillance has now been decimated to 40,000 annual tests (USDA news release no. 0255.06, July 20, 2006) and invites the accusation that the United States will never know the true status of its involvement with BSE.

In short, a great deal of further work will need to be done before the phenotypic features and prevalence of atypical BSE are understood. More than a single strain may have been present from the beginning of the epidemic, but this possibility has been overlooked by virtue of the absence of widespread Western blot confirmatory testing of positive screening test results; or these new phenotypes may be found, at least in part, to result from infections at an older age by a typical BSE agent, rather than neonatal infections with new "strains" of BSE. Neither alternative has yet been investigated.

http://www.cdc.gov/ncidod/EID/vol12no12/06-0965.htm

Cases of atypical BSE have only been found in countries having implemented large active surveillance programs. As of 1st September 2007, 36 cases (16 H, 20 L) have been described all over the world in cattle: Belgium (1 L) [23], Canada (1 H)15, Denmark (1 L)16, France (8 H, 6 L)17, Germany (1 H, 1 L) [13], Italy (3 L)18, Japan (1 L) [71], Netherlands (1 H, 2 L)19, Poland (1 H, 6 L)20, Sweden (1 H)21, United Kingdom (1 H)22, and USA (2 H)23. Another H-type case has been found in a 19 year old miniature zebu in a zoological park in Switzerland [56]. It is noteworthy that atypical cases have been found in countries that did not experience classical BSE so far, like Sweden, or in which only few cases of classical BSE have been found, like Canada or the USA.

And last but not least, similarities of PrPres between Htype BSE and human prion diseases like CJD or GSS have been put forward [10], as well as between L-type BSE and CJD [17]. These findings raise questions about the origin and inter species transmission of these prion diseases that were discovered through the BSE active surveillance.

full text 18 pages ;

http://www.vetres.org/index.php?option=article&access=standard&Itemid=129&url=/articles/vetres/pdf/2008/04/v07232.pdf

USDA Food Safety & Inspection Service

Freedom of Information Act Requests received: February 1, 2008 to February 29, 2008

http://www.fsis.usda.gov/PDF/FOIA_Requests_0208.pdf

Thursday, April 24, 2008 RE-FOIA OF DECLARATION OF EXTRAORDINARY EMERGENCY BECAUSE OF AN ATYPICAL T.S.E. OF FOREIGN ORIGIN IN THE UNITED STATES [Docket No. 00-072-1]

http://foiamadsheepmadrivervalley.blogspot.com/2008/04/re-foia-of-declaration-of-extraordinary.html

SEAC Draft minutes of the 100th meeting held on 25th April 2008

http://seac992007.blogspot.com/2008/07/seac-draft-minutes-of-100th-meeting.html

Friday, July 18, 2008 TSE risk assessment from carcasses of ovine and caprine animals below 6 months of age from TSE infected flocks intended for human consumption

http://nor-98.blogspot.com/2008/07/tse-risk-assessment-from-carcasses-of.html

Tuesday, June 3, 2008

SCRAPIE USA UPDATE JUNE 2008 NOR-98 REPORTED PA

http://nor-98.blogspot.com/2008/06/scrapie-usa-update-june-2008-nor-98.html

Tuesday, June 3, 2008 SCRAPIE USA UPDATE JUNE 2008 NOR-98 REPORTED PA

http://nor-98.blogspot.com/2008/06/scrapie-usa-update-june-2008-nor-98.html

Thursday, April 03, 2008 A prion disease of cervids: Chronic wasting disease 2008

1: Vet Res. 2008 Apr 3;39(4):41

http://chronic-wasting-disease.blogspot.com/2008/04/prion-disease-of-cervids-chronic.html

Transmissible Mink Encephalopathy TME

http://transmissible-mink-encephalopathy.blogspot.com/


Thursday, July 10, 2008

A Novel Human Disease with Abnormal Prion Protein Sensitive to Protease update July 10, 2008

http://cjdmadcowbaseoct2007.blogspot.com/2008/07/novel-human-disease-with-abnormal-prion.html



Thursday, July 10, 2008

A New Prionopathy update July 10, 2008

http://cjdmadcowbaseoct2007.blogspot.com/2008/07/new-prionopathy-update-july-10-2008.html

Wednesday, July 23, 2008


WARNING LETTER An inspection of your licensed medicated feed mill, Cargill, Inc. 1000% higher than the levels indicated on the product's label. ...

http://staphmrsa.blogspot.com/2008/07/warning-letter-inspection-of-your.html

Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518