June 12, 2008
FEDERAL OVERSIGHT OF FOOD SAFETY
FDA Has Provided Few Details on the Resources and Strategies Needed to Implement its Food Protection Plan
What GAO Found
Since FDA’s Food Protection Plan was first released in November 2007, FDA has added few details on the resources and strategies required to implement the plan. FDA plans to spend about $90 million over fiscal years 2008 and 2009 to implement several key actions, such as identifying food vulnerabilities and risk. From the information GAO has obtained on the Food Protection Plan, however, it is unclear what FDA’s overall resource need is for implementing the plan, which could be significant. For example, based on FDA estimates, if FDA were to inspect each of the approximately 65,500 domestic food firms regulated by FDA once, the total cost would be approximately $524 million. In addition, timelines for implementing the various strategies in the plan are also unclear, although a senior level FDA official estimated that the overall plan will take 5 years to complete. Importantly, GAO has noted that public reporting is the means through which the federal government communicates the results of its work to the Congress and the American people. FDA officials told GAO that they had prepared a draft report on progress made in implementing the Food Protection Plan, but as of June 4, 2008, FDA told GAO that the Department of Health and Human Services had not cleared the report for release. The Food Protection Plan identifies the need to focus safety inspections based on risk, which is particularly important as the numbers of food firms have increased while inspections have decreased. For example, between 2001 and 2007, the number of domestic firms under FDA’s jurisdiction increased from about 51,000 to more than 65,500, while the number of firms inspected declined slightly, from 14,721 to 14,566. Thus, conducting safety inspections based on risk has the potential to be an efficient and effective approach for FDA to target scarce resources based on relative vulnerability and risk. FDA has implemented few of GAO’s past recommendations to leverage its resources and improve food safety oversight. Since 2004, GAO has made a total of 34 food safety related recommendations to FDA, and as of May 2008, FDA has implemented 7 of these recommendations. For the remaining recommendations, FDA has not fully implemented them, however, in some cases, FDA has taken some steps. However, the planned activities in the Food Protection Plan could help address several of the recommendations that FDA has not implemented. For example, in January 2004, GAO recommended that FDA make it a priority to establish equivalence agreements with other countries. We found that such agreements would shift some of FDA’s oversight burden to foreign governments. As of May 2008, FDA has not yet established equivalence agreements with any foreign countries. The Food Protection Plan requests that Congress allow the agency to enter into agreements with exporting countries to certify that foreign producers’ shipments of designated high-risk products comply with FDA standards.
Highlights of GAO-08-909T, a testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives
Why GAO Did This Study
The Food and Drug Administration (FDA) is responsible for ensuring the safety of roughly 80 percent of the U.S. food supply, including $417 billion worth of domestic food and $49 billion in imported food annually. Changing demographics and consumption patterns along with an increase in imports have presented challenges to FDA. At the same time, recent outbreaks, such as E. coli from spinach and Salmonella from tomatoes, have undermined consumer confidence in the safety of the food supply. In November 2007, FDA released its Food Protection Plan, which articulates a framework for improving food safety oversight. In January 2008, GAO expressed concerns about FDA’s capacity to implement the Food Protection Plan and noted that more specific information about the strategies and resources needed to implement the plan would facilitate congressional oversight. This testimony focuses on (1) FDA’s progress in implementing the Food Protection Plan, (2) FDA’s proposal to focus inspections based on risk, and (3) FDA’s implementation of previously issued GAO recommendations intended to improve food safety oversight. To address these issues, GAO reviewed FDA documents, such as FDA’s operations plan, and FDA data related to the plan. GAO also interviewed FDA officials regarding the progress made. GAO also analyzed FDA data on domestic and foreign food firm inspections. GAO also analyzed the status of past recommendations.
To view the full product, including the scope and methodology, click on GAO-08-909T. For more information, contact Lisa Shames at (202) 512-3841 or email@example.com.
SEE FULL TEXT ;
September 28, 2007 FDA OIG - Food and Drug Administration’s Oversight of Clinical Trials Press release,OIG Releases Report of FDA’s Oversight of Clinical Trials, Concludes Improvement of Information Systems and Processes is Needed, September 2007: "Weaknesses in the Food and Drug Administration’s (FDA) information systems and management processes hinder the agency’s ability to oversee clinical trial inspections. So concludes Inspector General Daniel R. Levinson of the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) in a report released today...To protect human subjects, federal law requires that all new drugs and medical devices undergo clinical trials to demonstrate their safety and efficacy prior to receiving FDA approval. FDA inspects clinical trials to determine whether sponsors, clinical investigators, and institutional review boards responsible for conducting or overseeing clinical trials for investigational products are complying with relevant regulations. FDA oversees clinical trials through a variety of mechanisms that include protocol reviews and onsite inspections through its Bioresearch Monitoring Program (BiMo). The OIG report focused exclusively on BiMo inspections, an important mechanism for protecting human subjects once a clinical trial is underway. OIG concluded that the FDA does not have a mechanism to identify all clinical trials and Institutional Review Boards (IRBs), which approve, monitor, and review research involving human subjects. Moreover, it lacks a comprehensive database for tracking its inspections of clinical trials. Previous OIG reports found similar weaknesses."
Department of Health and Human Services, Office of Inspector General - The Food and Drug Administration’s Oversight of Clinical Trials, released September 28, 2007. (41 pages, PDF)
>>>Importantly, GAO has noted that public reporting is the means through which the federal government communicates the results of its work to the Congress and the American people.<<<
Owner and Corporation Plead Guilty to Defrauding Bovine Spongiform Encephalopathy (BSE) Surveillance Program An Arizona meat processing company and its owner pled guilty in February 2007 to charges of theft of Government funds, mail fraud, and wire fraud. The owner and his company defrauded the BSE Surveillance Program when they falsified BSE Surveillance Data Collection Forms and then submitted payment requests to USDA for the services. In addition to the targeted sample population (those cattle that were more than 30 months old or had other risk factors for BSE), the owner submitted to USDA, or caused to be submitted, BSE obex (brain stem) samples from healthy USDA-inspected cattle. As a result, the owner fraudulently received approximately $390,000. Sentencing is scheduled for May 2007.
Topics that will be covered in ongoing or planned reviews under Goal 1 include: soundness of BSE maintenance sampling (APHIS), implementation of Performance-Based Inspection System enhancements for specified risk material (SRM) violations and improved inspection controls over SRMs (FSIS and APHIS), snip... The findings and recommendations from these efforts will be covered in future semiannual reports as the relevant audits and investigations are completed. 4 USDA OIG SEMIANNUAL REPORT TO CONGRESS FY 2007 1st Half
-MORE Office of the United States Attorney District of Arizona FOR IMMEDIATE RELEASE For Information Contact Public Affairs February 16, 2007 WYN HORNBUCKLE Telephone: (602) 514-7625 Cell: (602) 525-2681
CORPORATION AND ITS PRESIDENT PLEAD GUILTY TO DEFRAUDING GOVERNMENT’S MAD COW DISEASE SURVEILLANCE PROGRAM
PHOENIX -- Farm Fresh Meats, Inc. and Roland Emerson Farabee, 55, of Maricopa, Arizona, pleaded guilty to stealing $390,000 in government funds, mail fraud and wire fraud, in federal district court in Phoenix. U.S. Attorney Daniel Knauss stated, “The integrity of the system that tests for mad cow disease relies upon the honest cooperation of enterprises like Farm Fresh Meats. Without that honest cooperation, consumers both in the U.S. and internationally are at risk. We want to thank the USDA’s Office of Inspector General for their continuing efforts to safeguard the public health and enforce the law.” Farm Fresh Meats and Farabee were charged by Information with theft of government funds, mail fraud and wire fraud. According to the Information, on June 7, 2004, Farabee, on behalf of Farm Fresh Meats, signed a contract with the U.S. Department of Agriculture (the “USDA Agreement”) to collect obex samples from cattle at high risk of mad cow disease (the “Targeted Cattle Population”). The Targeted Cattle Population consisted of the following cattle: cattle over thirty months of age; nonambulatory cattle; cattle exhibiting signs of central nervous system disorders; cattle exhibiting signs of mad cow disease; and dead cattle. Pursuant to the USDA Agreement, the USDA agreed to pay Farm Fresh Meats $150 per obex sample for collecting obex samples from cattle within the Targeted Cattle Population, and submitting the obex samples to a USDA laboratory for mad cow disease testing. Farm Fresh Meats further agreed to maintain in cold storage the sampled cattle carcasses and heads until the test results were received by Farm Fresh Meats.
Evidence uncovered during the government’s investigation established that Farm Fresh Meats and Farabee submitted samples from cattle outside the Targeted Cattle Population. Specifically, Farm Fresh Meats and Farabee submitted, or caused to be submitted, obex samples from healthy, USDA inspected cattle, in order to steal government moneys.
Evidence collected also demonstrated that Farm Fresh Meats and Farabee failed to maintain cattle carcasses and heads pending test results and falsified corporate books and records to conceal their malfeasance. Such actions, to the extent an obex sample tested positive (fortunately, none did), could have jeopardized the USDA’s ability to identify the diseased animal and pinpoint its place of origin. On Wednesday, February 14, 2007, Farm Fresh Meats and Farabee pleaded guilty to stealing government funds and using the mails and wires to effect the scheme. According to their guilty pleas:
(a) Farm Fresh Meats collected, and Farabee directed others to collect, obex samples from cattle outside the Targeted Cattle Population, which were not subject to payment by the USDA;
(b) Farm Fresh Meats 2 and Farabee caused to be submitted payment requests to the USDA knowing that the requests were based on obex samples that were not subject to payment under the USDA Agreement;
(c) Farm Fresh Meats completed and submitted, and Farabee directed others to complete and submit, BSE Surveillance Data Collection Forms to the USDA’s testing laboratory that were false and misleading;
(d) Farm Fresh Meats completed and submitted, and Farabee directed others to complete and submit, BSE Surveillance Submission Forms filed with the USDA that were false and misleading;
(e) Farm Fresh Meats falsified, and Farabee directed others to falsify, internal Farm Fresh Meats documents to conceal the fact that Farm Fresh Meats was seeking and obtaining payment from the USDA for obex samples obtained from cattle outside the Targeted Cattle Population; and
(f) Farm Fresh Meats failed to comply with, and Farabee directed others to fail to comply with, the USDA Agreement by discarding cattle carcasses and heads prior to receiving BSE test results. A conviction for theft of government funds carries a maximum penalty of 10 years imprisonment. Mail fraud and wire fraud convictions carry a maximum penalty of 20 years imprisonment. Convictions for the above referenced violations also carry a maximum fine of $250,000 for individuals and $500,000 for organizations. In determining an actual sentence, Judge Earl H. Carroll will consult the U.S. Sentencing Guidelines, which provide appropriate sentencing ranges. The judge, however, is not bound by those guidelines in determining a sentence.
Sentencing is set before Judge Earl H. Carroll on May 14, 2007. The investigation in this case was conducted by Assistant Special Agent in Charge Alejandro Quintero, United States Department of Agriculture, Office of Inspector General. The prosecution is being handled by Robert Long, Assistant U.S. Attorney, District of Arizona, Phoenix. CASE NUMBER: CR-07-00160-PHX-EHC RELEASE NUMBER: 2007-051(Farabee) # # #
Thu Dec 6, 2007 11:38
FDA IN CRISIS MODE, AMERICAN LIVES AT RISK
FDA SCIENCE AND MISSION AT RISK
In 2007, in one weekly enforcement report, the fda recalled 10,000,000+ pounds of BANNED MAD COW FEED, 'in commerce', and i can tell you that most of it was fed out ;
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 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
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
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 cow protein '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
SPECIFIED RISK MATERIALS
SRM MAD COW RECALL 406 THOUSAND POUNDS CATTLE HEADS WITH TONSILS KANSAS
MAD COW DISEASE terminology UK c-BSE (typical), atypical BSE H or L, and or Italian L-BASE
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
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.
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) , Canada (1 H)15, Denmark (1 L)16, France (8 H, 6 L)17, Germany (1 H, 1 L) , Italy (3 L)18, Japan (1 L) , 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 . 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 , as well as between L-type BSE and CJD . 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 ;
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.
Tuesday, June 3, 2008SCRAPIE USA UPDATE JUNE 2008 NOR-98 REPORTED PA
Here we report that both Nor98 and discordant cases, including three sheep homozygous for the resistant PrPARR allele (A136R154R171), efficiently transmitted the disease to transgenic mice expressing ovine PrP, and that they shared unique biological and biochemical features upon propagation in mice. These observations support the view that a truly infectious TSE agent, unrecognized until recently, infects sheep and goat flocks and may have important implications in terms of scrapie control and public health.
Edited by Stanley B. Prusiner, University of California, San Francisco, CA, and approved September 12, 2005 (received for review March 21, 2005)
***The pathology features of Nor98 in the cerebellum of the affected sheep showed similarities with those of sporadic Creutzfeldt-Jakob disease in humans.
*** twenty-seven CJD patients who regularly consumed venison were reported to the Surveillance Center***,
snip...see full text 19 pages ;
SEE FULL TEXT CWD ;
Communicated by: Terry S. Singeltary Sr.
[In submitting these data, Terry S. Singeltary Sr. draws attention to the steady increase in the "type unknown" category, which, according to their definition, comprises cases in which vCJD could be excluded. The total of 26 cases for the current year (2007) is disturbing, possibly symptomatic of the circulation of novel agents. Characterization of these agents should be given a high priority. - Mod.CP]
There is a growing number of human CJD cases, and they were presented last week in San Francisco by Luigi Gambatti(?) from his CJD surveillance collection.
He estimates that it may be up to 14 or 15 persons which display selectively SPRPSC and practically no detected RPRPSC proteins.
The statistical incidence of CJD cases in the United States has been revised to reflect that there is one case per 9000 in adults age 55 and older. Eighty-five percent of the cases are sporadic, meaning there is no known cause at present.
Economics and Trade STATEMENT OF DR. RICHARD RAYMOND
DR. RICHARD RAYMOND
USDA UNDERSECRETARY FOR FOOD SAFETY
Regarding the Safety of the U.S. Food Supply May 4, 2008 “Good evening. I am Dr. Richard Raymond, Under Secretary for Food Safety at the U.S. Department of Agriculture. I appreciate the opportunity to discuss with you the safety of the U.S. beef supply. I want to be sure that you are aware that I will be discussing food safety issues only, and I am not here this evening to discus negotiations.
“The U.S. Government believes the current agreement well addresses the health and food safety concerns of Korean consumers. It provides for Korea's sovereign right to conduct an audit of our facilities and to work with USDA inspection authorities if any food safety concerns are identified. When the OIE gave the United States "controlled risk" status a year ago, it was after the world's BSE experts reviewed the preventative and food safety measures in the United States.
“Since the requirements to export to Korea are consistent with science, U.S. requirements as well as those of the OIE require that if any food safety concern is found, it would be fully investigated and immediately corrected by USDA.
“I want to assure all consumers – both domestic and abroad – that the U.S. beef supply is among the safest in the world. To help ensure its safety, USDA takes a number of steps to prevent foodborne illness. USDA’s Food Safety and Inspection Service (FSIS) employs over 9,000 personnel, including 7,800 full-time in-plant and other front-line personnel protecting the public health in approximately 6,200 federally inspected establishments nationwide. FSIS personnel must be continuously present for slaughter operations and observe the animal both in motion and at rest before slaughter, and every carcass after slaughter. FSIS also must be present in each processing establishment every shift every day. Under the FSIS verification sampling program, FSIS samples meat, poultry, and processed egg products and analyzes them for the presence of microbial pathogens. To protect against bovine spongiform encephalopathy (BSE), the U.S. government also has an interlocking system of safeguards.
Safeguards Against BSE
“I would like to take this opportunity to give you a brief summary of the safeguards against BSE that the United States has in place to protect our food supply.
“Since the discovery of the first case of BSE in Great Britain in 1986, we have learned a tremendous amount about this disease. That knowledge has greatly informed USDA’s regulatory systems and response efforts. It has also given us the opportunity to examine our own cattle herd, which is why we know that the risk of BSE in the United States is extremely low.
“The U.S. government’s interlocking system of controls to protect the food supply from BSE includes a ban on non-ambulatory disabled cattle since January 2004. On July 12, 2007, FSIS announced a permanent prohibition on the non-ambulatory disabled or “downer” cattle from the food supply, with the exception of otherwise normal, healthy animals that become non-ambulatory because of an acute injury after passing ante-mortem inspection.
“We have learned that the single most important thing we can do to protect human health regarding BSE is the removal from the food supply of specified risk materials (SRMs) – those tissues that, according to scientific evidence, could be infective in a cow with BSE. USDA requires that all SRMs are removed from carcasses so that they do not enter the food supply. Slaughter facilities cannot operate their slaughter operations without the continuous presence of USDA inspection personnel to ensure safe and wholesome product, including the removal, segregation and disposal of SRMs. According to the 2005 Harvard Risk Assessment, SRM removal alone reduces the potential exposure to consumers of BSE by 99 percent. USDA inspectors are stationed at key points along the production line where they are able to directly observe certain SRM removal activities. Other off-line inspection personnel verify additional plant SRM removal, segregation and disposal. Moreover, FDA bans SRMs in FDA-regulated human foods and cosmetics.
“An additional significant step we have taken to prevent the spread of BSE and bring about its eradication in the animal population is the ruminant feed ban. In 1997, the FDA implemented a mandatory feed ban that prohibits feeding most mammalian protein to ruminants, including cattle. This rule was strengthened just recently in a final rule published April 25, 2008. The feed ban is a vital measure to prevent the transmission of BSE to cattle. While the 1997 rule provides a strong primary line of defense against BSE, as evidenced by the extremely low prevalence of BSE in the U.S., the additional measures taken in this final rule, which goes into effect 12 months from the date of publication, will further reinforce the existing rule by removing certain cattle derived materials from all animal feed. This action will minimize any residual BSE risks not eliminated by the 1997 rule, if cross contamination of ruminant feed with non ruminant feed, or diversion of non ruminant feeds to ruminants, were to occur. In fact, this feed ban goes beyond what is required by OIE, and that is significant.
“Another step is BSE testing, which is best used as a surveillance tool. By testing high-risk animals, including those that show possible clinical signs of the disease, we can document the effectiveness of our security measures.
“USDA’s Animal and Plant Health Inspection Service (APHIS) has conducted targeted BSE surveillance testing since 1990, including an enhanced surveillance effort that was initiated after a cow tested positive for the disease in December 2003. The goal of the enhanced effort, which began in June 2004, was to test as many animals in the targeted population of dead, down, or disabled cattle as possible over a 24-month period. Out of over 759,000 animals tested, this intensive effort detected only two additional animals with the disease. Both of those animals were born prior to initiation of the FDA feed ban and neither entered the food supply. This testing confirms an extremely low prevalence of the disease in the United States and the efficacy of the feed banning preventing transmission of BSE to the American herd.
“The enhanced surveillance program provided sufficient data to allow USDA to more accurately estimate the prevalence or level of BSE within the U.S. cattle population. Based on this analysis, we can definitively say that the incidence of BSE in the United States is extremely low. APHIS continues to conduct an ongoing BSE surveillance program targeted to high-risk animals that samples approximately 40,000 high-risk animals annually. This level of surveillance significantly exceeds the guidelines set forth by the World Animal Health Organization, which has affirmed that U.S. regulatory controls against the disease are effective.
“It is because of the strong system that the United States has put in place, and which we continue to work to strengthen, that we can be confident of the safety of our beef supply in regard to BSE and that the spread of BSE has been prevented in this nation.
Hallmark/Westland Meat Packing Co.
“I also want to discuss with you the undercover video by the Humane Society that was released on January 30. As soon as the video was released, USDA Secretary Schafer called for an investigation into the matter. USDA’s Office of the Inspector General (OIG) is leading that investigation, with support from FSIS and the Agricultural Marketing Service (AMS). This investigation is still ongoing, and in the meantime, FSIS has implemented a series of interim actions to verify and thoroughly analyze humane handling activities in federally inspected establishments.
“When we learned of the problems at Hallmark/Westland on January 30, FSIS took immediate steps to determine if the allegations made public by the Humane Society of the United States (HSUS) were accurate. I also want to stress to you that the animals in the video are in no way indicative of animals that would ever pass ante-mortem inspection.
“Evidence from the ongoing investigation demonstrates that, over the past two years, this plant did not always notify the FSIS public health veterinarian (PHV) when cattle became non-ambulatory after passing ante-mortem (prior to slaughter) inspection, as is required by FSIS regulations. This failure by Hallmark/Westland led to the company’s February 17, 2008, voluntary recall of 143 million pounds of fresh and frozen beef products produced at the establishment since February 1, 2006. Because of the previously explained interlocking safeguards against BSE exposure, it is extremely unlikely that these meat products pose a risk to human health. The recall action was deemed necessary because the establishment did not comply with FSIS regulations. This recall was not about food safety.
“It is important to note that certain cattle, while ambulatory when they pass ante-mortem inspection, may later become non-ambulatory from an acute injury or another circumstance. If such a situation occurs, FSIS regulations require the PHV to inspect the animal again and determine that the animal did indeed suffer from an acute injury before the animal is permitted to go to slaughter. Otherwise, the animal is condemned, does not go to slaughter, and therefore, does not enter the food chain. It is also significant to understand that this plant had five full-time USDA inspectors who were doing their jobs to protect public health. Over the last three years, these inspectors condemned five percent of the cattle that were presented for slaughter. Most of the condemned were as a result of carcass and/or organ inspection post slaughter.
“Last year, humane handling violations resulted in FSIS issuing notices of suspension of inspection, which effectively stop operations at a facility, to 12 of nearly 800 livestock slaughter plants. In 2007, FSIS issued 685 non-compliance records for humane handling issues out of more than 168,000 humane handling verification procedures – demonstrating that there is a very low level of less than egregious activity in plants. In general, these violations are minor and do not affect the safety and wholesomeness of our food supply. USDA believes that operating our inspection system in a transparent manner keeps our consumers informed and helps us strengthen an already strong food safety system.
“The investigation led by OIG with support from FSIS and AMS is ongoing. However, we are not waiting for the completion of the investigation to act.
“USDA has already taken a number of steps to strengthen our inspection system. FSIS has increased the amount of time allocated per shift by inspection program personnel to verify humane handling activities and to verify that animals are handled humanely in ante-mortem areas. FSIS is focusing surveillance and inspection activities at establishments where older or potentially distressed animals are slaughtered, such as facilities that handle dairy or veal cattle. At these facilities, the time spent performing humane handling verification activities will be doubled. At facilities with contracts for for Federal nutrition assistance programs, humane handling verification time is being doubled, regardless of the type or class of the animal slaughtered.
“FSIS is also conducting surveillance activities to observe the handling of animals outside the approved hours of operation from vantage points within and adjacent to the official premises. FSIS has been and will continue to conduct humane handling audits in additional plants across the U.S.
“One last point that I would like to address is regarding a human health issue. I am certain that many of you are aware that an investigation was being conducted to determine the cause of death from a young patient in Virginia who was recently reported in the in the media to have died of variant Creutzfeldt-Jacob disease (vCJD). The epidemiologic characteristics of the illness and preliminary results of the neuropathologic testing of brain tissue obtained at autopsy indicate that the patient did not die of vCJD. The U.S. Centers for Disease Control and Prevention has just provided us with that information, and I felt it was important to share that with you today. An official release once all testing is completed and confirmed is expected soon, but the CDC has allowed me to offer you this preliminary information today.
“Again – I want to stress to all consumers – both domestic and abroad – that U.S. beef is safe. USDA takes a number of steps to prevent foodborne illness. The U.S. government’s interlocking system of controls to protect the food supply from BSE is effective and provide a level of security recognized as significant worldwide.”
NOTE: Access news releases and other information at the FSIS Web site at
Monday, May 5, 2008
STATEMENT OF DR. RICHARD RAYMOND USDA UNDERSECRETARY FOR FOOD SAFETY May 4, 2008
bought and paid for by your local cattle dealer $$$
IN my opinion the WOAH/OIE is nothing more than a organized bunch of lobbyist for the members Countries in support of there INDUSTRY, bound together as one, with the only purpose of open trade for there precious commodities and futures. Speaking only of BSE, they failed at every corner, and then just said to hell with it, well just trade all strains of TSE globally.
snip...SEE FULL TEXT with facts and sources @ ;
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-2006-0041-0028.1 Public Submission Title Attachment to Singeltary comment Views
PLEASE see full text here ;
U.S. slams door on revising S. Korea beef import pact
June 11, 2008, 10:14PM
-------- Original Message --------
Subject: re-USDA's surveillance plan for BSE aka mad cow disease
Date: Mon, 02 May 2005 16:59:07 -0500
From: "Terry S. Singeltary Sr."
To: firstname.lastname@example.org, HHSTips@oig.hhs.gov, contactOIG@hhsc.state.tx.us
Greetings Honorable Paul Feeney, Keith Arnold, and William Busbyet al at OIG, ...............
There will be several more emails of my research to follow.
I respectfully request a full inquiry into the cover-up of TSEs in the United States of America over the past 30 years. I would be happy to testify...
Thank you, I am sincerely,
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518xxx xxx xxxx
Date: June 14, 2005 at 1:46 pm PST
In Reply to: Re: Transcript Ag. Secretary Mike Johanns and Dr. John Clifford, Regarding further analysis of BSE Inconclusive Test Results
posted by TSS on June 13, 2005 at 7:33 pm:
Secretary of Agriculture Ann M. Veneman resigns Nov 15 2004, three days later inclusive Mad Cow is announced. June 7th 2005 Bill Hawks Under Secretary for Marketing and Regulatory Programs resigns. Three days later same mad cow found in November turns out to be positive. Both resignation are unexpected.
-------- Original Message --------
Subject: Re: BSE 'INCONCLUSIVE' COW fromTEXAS ???
Date: Mon, 22 Nov 2004 17:12:15 -0600
From: "Terry S. Singeltary Sr."
To: Carla EverettReferences: <[log in to unmask]><[log in to unmask] us>
Greetings Carla, still hear a rumor;
Texas single beef cow not born in Canada no beef entered the food chain?
and i see the TEXAS department of animal health is ramping up for something,but they forgot a url for update?
I HAVE NO ACTUAL CONFIRMATION YET...
can you confirm??? terry
-------- Original Message --------
Subject: Re: BSE 'INCONCLUSIVE' COW from TEXAS ???
Date: Fri, 19 Nov 2004 11:38:21 -0600
From: Carla Everett
To: "Terry S. Singeltary Sr."References: <[log in to unmask]>
The USDA has made a statement, and we are referring all callers to the USDAweb site. We have no informationabout the animal being in Texas.
At 09:44 AM 11/19/2004, you wrote:
>>i am getting unsubstantiated claims of this BSE 'inconclusive' cow is from
>TEXAS. can you comment on this either way please?
>Terry S. Singeltary Sr.>>
-------- Original Message --------
Subject: Re: BSE 'INCONCLUSIVE' COW from TEXAS ???
Date: Mon, 22 Nov 2004 18:33:20 -0600
From: Carla Everett
To: "Terry S. Singeltary Sr."
References: <[log in to unmask]><[log in to unmask] us><[log in to unmask]> <[log in to unmask]us> <[log in to unmask]>
our computer department was working on a place holder we could post USDA'sannouncement of any results. There are no results to be announced tonight by NVSL, so we are back in a waiting mode and will post the USDA announcement when we hear something.
At 06:05 PM 11/22/2004,
>why was the announcement on your TAHC site removed?
>>Bovine Spongiform Encephalopathy:
>November 22: Press Release title here
>>star image More BSE information
>>Carla Everett wrote:
>>>no confirmation on the U.S.'inconclusive test...
>>no confirmation on location of animal.>>>>>>
***Aug. 30, 2005***
Investigation Results of Texas Cow That Tested Positive for Bovine Spongiform Encephalopathy (BSE)
Release No. 0336.05 Contact: USDA Jim Rogers 202-690-4755 FDA Rae Jones 301-827- 6242
Printable version Email this page
U.S. Department of Agriculture (USDA) Food and Drug Administration (FDA)
Investigation Results of Texas Cow That Tested Positive for Bovine Spongiform Encephalopathy (BSE) Aug. 30, 2005
The U.S. Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) and the U.S. Department of Health and Human Services' Food and Drug Administration (FDA) have completed their investigations regarding a cow that tested positive for bovine spongiform encephalopathy (BSE) in June 2005. The agencies conducted these investigations in collaboration with the Texas Animal Health Commission and the Texas Feed and Fertilizer Control Service.
Our results indicate that the positive animal, called the index animal, was born and raised on a ranch (termed the "index farm") in Texas. It was a cream colored Brahma cross approximately 12 years old at the time of its death. It was born prior to the implementation of the 1997 feed ban instituted by FDA to help minimize the risk that a cow might consume feed contaminated with the agent thought to cause BSE. The animal was sold through a livestock sale in November of 2004 and transported to a packing plant. The animal was dead upon arrival at the packing plant and was then shipped to a pet food plant where it was sampled for BSE. The plant did not use the animal in its product, and the carcass was destroyed in November 2004.
snip... see full text ;
DeLauro is ranking member of the House Appropriations Agriculture subcommittee, which has jurisdiction and oversight responsibilities of USDA and FDA.
“I am concerned that the APHIS officials that reviewed these results seemed to make decisions based not on science, but on the economic ramifications a positive BSE finding in a domestic born animal could have on the U.S. economy,” said DeLauro. “When consumer safety is in question, APHIS should not be forced into additional testing of an inconclusive sample by its inspector general.
“While we are glad that this cow did not enter the human food supply, APHIS officials had a responsibility to further examine this sample that even our “gold standard” test proved inconclusive. By refusing to send samples for further testing, APHIS could have jeopardized consumer health and safety and put the industry at a disadvantage, drawing into question the safety of our beef.
“Today I am requesting that APHIS disclose which officials made this decision and further explain their reasoning for not voluntarily testing this inconclusive sample further.”
48 hr BSE confirmation turnaround took 7+ months to confirm this case, so the BSE MRR policy could be put into place. ...TSS
>>> I would be more worried about the latest USA suspect where no WB can be done, due to formalin fixation of the sample. I don’t know if the“reference” laboratory in Weybridge has ever missed any BSE-positive cattle (or atypical bovine TSEs), but they have certainly failed to confirm several cases of atypical scrapie, because they insisted on using the so-called validated methods recommended by the OIE before 2003. I hope they now have solved this problem.<<< i agree with this. in fact, the OIE since adhering to GWs BSE MRR policy (minimal risk region), and doing away with the USA, Canada, and Mexico BSE GBR Risk assessments, was anything but 'sound science'. by the OIE adhering to this 'junk science' of this administrations corporate scientists, the OIE has done nothing more than become a commodity brokerage for the legal trading of all phenotypes of TSEs Globally. THEY have in essence done away with 30 years of trying to eradicate TSEs globally. MILLIONS and millions of dollars down the drain, with MILLIONS and millions of humans and animals now becoming exposed even more than before, due to nothing more than greed and the almighty buck. as GW says, ''bring em on''. he will get exactly what he asks for again in the years and decades to come. but, as my birthday card today states; This birthday you have something to be thankful for (with a picture of GW on the front), I CAN'T RUN AGAIN....................amen! SO why should he care, he will not be in office, but the markets will be o.k. for now, borders open, and the list of demented and dead will continue to slowly grow even more, with more strains of TSE mutating and being exported throughout the globe... gee thanks GW/OIE! snip...end BESIDES the Texas mad cow that sat on the shelf for 7+ months before the Honorable Phyllis Fong of the OIG finally did the end around Johanns et al and finally had Weybridge bring that negative cow back from the dead to finally being a confirmed mad cow (hint, hint, getting MRR implemented first), was this simply another bumbling of BSE protocol, or just same old same old; Jim Rogers (202) 690-4755 USDA Press Office (202) 720-4623 Statement by Chief Veterinary Medical Officer John Clifford Animal and Plant Health Inspection Service Regarding Non-Definitive BSE Test ResultsJuly 27, 2005 snip... Our laboratory ran the IHC test on the sample and received non-definitive results that suggest the need for further testing. As we have previously experienced, it is possible for an IHC test to yield differing results depending on the “slice” of tissue that is tested. Therefore, scientists at our laboratory and at Weybridge will run the IHC test on additional “slices” of tissue from this animal to determine whether or not it was infected with BSE. We will announce results as soon as they are compiled, which we expect to occur by next week. I would note that the sample was taken in April, at which time the protocols allowed for a preservative to be used (protocols changed in June 2005). The sample was not submitted to us until last week, because the veterinarian set aside the sample after preserving it and simply forgot to send it in. On that point, I would like to emphasize that while that time lag is not optimal, it has no implications in terms of the risk to human health. The carcass of this animal was destroyed, therefore there is absolutely no risk to human or animal health from this animal.
Animal and Plant Health Inspection Service
Bovine Spongiform Encephalopathy (BSE) Surveillance Program - Phase II
Food Safety and Inspection Service
Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products - Phase III
Report No. 50601-10-KC January 2006
Finding 2 Inherent Challenges in Identifying and Testing High-Risk Cattle Still Remain
Our prior report identified a number of inherent problems in identifying and testing high-risk cattle. We reported that the challenges in identifying the universe of high-risk cattle, as well as the need to design procedures to obtain an appropriate representation of samples, was critical to the success of the BSE surveillance program. The surveillance program was designed to target nonambulatory cattle, cattle showing signs of CNS disease (including cattle testing negative for rabies), cattle showing signs not inconsistent with BSE, and dead cattle. Although APHIS designed procedures to ensure FSIS condemned cattle were sampled and made a concerted effort for outreach to obtain targeted samples, industry practices not considered in the design of the surveillance program reduced assurance that targeted animals were tested for BSE.
USDA/OIG-A/50601-10-KC Page 27
observe these animals ante mortem when possible to assure the animals from the target population are ultimately sampled and the clinical signs evaluated.
OH, and about that mad cow ruminant to ruminant SRM feed ban, and other slaughter-houses letting sick and diseased cattle going to the food supply. they claim the feed ban is what the other safe guard is for downers.nothing but ink on paper. $$$
i am reminded of a few things deep throat (high ranking official at usda) told me years ago;
The most frightening thing I have read all day is the report of Gambetti's finding of a new strain of sporadic cjd in young people.........Dear God, what in the name of all that is holy is that!!! If the US has different strains of scrapie.....why????than the UK...then would the same mechanisms that make different strains of scrapie here make different strains of BSE...if the patterns are different in sheep and mice for scrapie.....could not the BSE be different in the cattle, in the mink, in the humans.......I really think the slides or tissues and everything from these young people with the new strain of sporadic cjd should be put up to be analyzed by many, many experts in cjd........bse.....scrapie Scrape the damn slide and put it into mice.....wait.....chop up the mouse brain and and spinal cord........put into some more mice.....dammit amplify the thing and start the damned research.....This is NOT rocket science...we need to use what we know and get off our butts and move....the whining about how long everything takes.....well it takes a whole lot longer if you whine for a year and then start the research!!! Not sure where I read this but it was a recent press release or something like that: I thought I would fall out of my chair when I read about how there was no worry about infectivity from a histopath slide or tissues because they are preserved in formic acid, or formalin or formaldehyde.....for God's sake........ Ask any pathologist in the UK what the brain tissues in the formalin looks like after a year.......it is a big fat sponge...the agent continues to eat the brain ......you can't make slides anymore because the agent has never stopped........and the old slides that are stained with Hemolysin and Eosin......they get holier and holier and degenerate and continue...what you looked at 6 months ago is not there........Gambetti better be photographing every damned thing he is looking at.....
Okay, you need to know. You don't need to pass it on as nothing will come of it and there is not a damned thing anyone can do about it. Don't even hint at it as it will be denied and laughed at.......... USDA is gonna do as little as possible until there is actually a human case in the USA of the nvcjd........if you want to move this thing along and shake the earth....then we gotta get the victims families to make sure whoever is doing the autopsy is credible, trustworthy, and a saint with the courage of Joan of Arc........I am not kidding!!!! so, unless we get a human death from EXACTLY the same form with EXACTLY the same histopath lesions as seen in the UK nvcjd........forget any action........it is ALL gonna be sporadic!!!
And, if there is a case.......there is gonna be every effort to link it to international travel, international food, etc. etc. etc. etc. etc. They will go so far as to find out if a sex partner had ever traveled to the UK/europe, etc. etc. .... It is gonna be a long, lonely, dangerous twisted journey to the truth. They have all the cards, all the money, and are willing to threaten and carry out those threats....and this may be their biggest downfall...
Thanks as always for your help. (Recently had a very startling revelation from a rather senior person in government here..........knocked me out of my chair........you must keep pushing. If I was a power person....I would be demanding that there be a least a million bovine tested as soon as possible and agressively seeking this disease. The big players are coming out of the woodwork as there is money to be made!!! In short: "FIRE AT WILL"!!! for the very dumb....who's "will"! "Will be the burden to bare if there is any coverup!"
again it was said years ago and it should be taken seriously....BSE will NEVER be found in the US! As for the BSE conference call...I think you did a great service to freedom of information and making some people feign integrity...I find it scary to see that most of the "experts" are employed by the federal government or are supported on the "teat" of federal funds. A scary picture! I hope there is a confidential panel organized by the new government to really investigate this thing.
You need to watch your back........but keep picking at them.......like a buzzard to the bone...you just may get to the truth!!! (You probably have more support than you know. Too many people are afraid to show you or let anyone else know. I have heard a few things myself... you ask the questions that everyone else is too afraid to ask.)
Questions linger in U.S. CJD cases
Published: Oct. 19, 2005 at 8:37 PM E-mail Story Print Preview License
By STEVE MITCHELLSenior Medical CorrespondentWASHINGTON, Oct. 19 (UPI) -- French researchers have ruled out the human form of mad cow disease in a deceased California man, even though they did not conduct the critical test widely regarded as the only way to determine precisely the nature of his disease, United Press International has learned.
The case of Patrick Hicks, who died last November from his condition, has remained murky from the beginning. Dr. Ron Bailey, of Riverside, Calif., the man's neurologist, had suspected the 49-year-old Hicks of having contracted variant Creutzfeldt Jakob disease -- a fatal, brain-wasting illness humans can contract from eating beef products contaminated with the mad cow pathogen -- and both he and the family wanted an autopsy conducted to determine if Hicks had succumbed to the disorder.
Bailey became concerned that Hicks might have contracted vCJD because he initially had exhibited psychiatric symptoms, his illness appears to have lasted for more than one year and he showed normal brain-wave patterns via EEGs until the late stages -- all consistent with the disease. In addition, Hicks's relatively young age raised concerns, because nearly all of the more than 150 cases of vCJD detected worldwide have occurred in people under age 55.
The first hint of oddness began when, according to both Hicks's brother and mother, a team of six doctors, who they suspect were with the Centers for Disease Control and Prevention in Atlanta, visited Patrick last October while he was still alive and under care at Loma Linda University Medical Center in Loma Linda, Calif.
They said they were asked to leave when the doctors arrived to examine Patrick.
CDC officials would not confirm to UPI whether they had investigated the case, but the agency's policy does require examining all suspected cases of vCJD in anyone under 55.
The family also said Loma Linda refused to released Hicks's medical records to them.
The oddities continued after Hicks's death. Bailey found it almost impossible to get an autopsy conducted on Hicks, the only way to determine conclusively whether he had variant or sporadic CJD -- a version of the disease not related to mad cow. One county coroner's office referred him to another and both refused to conduct the procedure, he said.
Then, the National Prion Disease Pathology Surveillance Center in Cleveland, Ohio -- which was established by the CDC to investigate potential vCJD cases in the United States -- dispatched a mobile autopsy company called 1-800-Autopsy, but the company failed to follow the center's protocol and did not collect frozen sections of brain, which are required for tests to determine whether the disease is vCJD or sCJD. Instead, the autopsy company fixed the entire brain in formalin.
The NPDPSC, however, considers the collection of frozen brain tissue essential to distinguishing vCJD from other forms of CJD.
"Only frozen brain tissue examination definitely confirms or excludes the diagnosis of prion disease and provides the information to identify the type of prion disease," the center's Web site says. Prions are abnormal proteins thought to play a role in causing vCJD and sCJD.
The problem raised enough concern that both Bailey and Hicks's family sought a second opinion.
Experts had told them that animal-injection studies could be done with formalin-fixed tissue, so the family arranged to have a sample of Patrick's brain sent to Dr. Jean Jacques Hauw at the Laboratoire De Neuropathologie at the Groupe Hospitalier Pitie-Salpetriere in Paris, who they thought had agreed to do the studies.
The NPDPSC, however, delayed sending the sample to France for two months after the family's request last March. During the delay, Pierluigi Gambetti, the NPDPSC's director, sent a letter to Hicks's wife.
"We can definitely rule out the diagnosis of variant CJD," the letter stated.
Gambetti's strong conclusion sounded strange to Bailey, because the NPDPSC had not conducted further tests since January, when they had said vCJD was unlikely but that they were unable to rule it out entirely.
After examining the brain tissue, Hauw's team told the family the disease was consistent with sCJD, but to date they have not explained why they did not conduct the animal-injection studies -- the family's reason for sending samples of his brain to France.
Asked the reasons for not following the family's wishes and conducting the animal studies, Hauw told UPI, "I cannot answer your question," citing French regulations that prohibited him from providing information about a specific patient.
He did say, however, that "animal injection is not needed for the routine diagnosis of Creutzfeldt-Jakob disease and its various variants, at least in France and in the United Kingdom."
That may be true, but it remains unclear why he accepted the case in the first place, knowing that is what the family wanted.
Moreover, this was not a "routine diagnosis." If Hicks suffered from vCJD, he potentially would have been the first person in the United States to have acquired the disease domestically, a development with significant domestic and international ramifications.
In addition, other experts, such as Dr. Laura Manuelidis, section chief of surgery in the neuropathology department at Yale University, have said the only way to know conclusively whether the disease is due to sCJD or vCJD is through animal-injection studies.
"From what I gather, the result was merely rubber stamped," Bailey told UPI. "I guess we will never really know for sure."
The handling of the case is noteworthy, because the NPDPSC currently is investigating nine potential sCJD cases in Idaho. Experts suspect some of those cases could be vCJD.
The handling of the case is noteworthy, because the NPDPSC currently is investigating nine potential sCJD cases in Idaho. Experts suspect some of those cases could be vCJD.
Bailey and some patient advocates said they are now skeptical of the NPDPSC's behavior.
"How could my experience with the Hicks case ... and the interaction with NPDPSC not lessen my confidence?" Bailey asked. "I anticipate that all of the Idaho cluster of CJD patients will turn out to have sCJD. I cannot for a minute see their results indicating anything but this. After all, if any patient were to have vCJD, it would have been Patrick Hicks. The results of NPDPSC are not definitive in excluding Hicks as not having vCJD. There certainly will always be that question in my mind."
Terry Singletary, a patient advocate whose mother died of a form of the disease called Heidenhain variant, told UPI he likewise had lost confidence in the NPDPSC.
"I do not trust them," Singletary said. "It's all going to be sporadic. This is the way they want it. They do not want to find out all the routes and sources of this agent."
Both vCJD and mad cow disease are politically sensitive issues because they can impact international trade. Dozens of nations closed their borders to American beef after a lone U.S. cow tested positive for the disease in 2003, resulting in more than $4.7 billion in losses for the industry, and the U.S. Department of Agriculture delayed doing confirmatory tests for seven months on what turned out to be a second case of mad cow.
The NPDPSC did not respond to UPI's phone call requesting comment about the Idaho cases. The CDC referred UPI to Idaho officials.
Of the nine Idaho cases, three people have tested positive for a CJD-like illness, but officials are conducting further tests to determine whether the disease is sCJD. Two others tested negative and four were buried without autopsies.
The cases could just be a statistical fluke, but the state averages about 1.2 sCJD cases per year and has never had more than three in a single year. The disease is rare and generally is thought to occur at the rate of one case per million people.
Several CJD clusters in other states have far exceeded that rate, however. These included:
--southern New Jersey (2000-2003),
--Lehigh, Pa. (1986-90),
--Allentown, Pa. (1989-92),
--Tampa, Fla. (1996-97),
--Oregon (2001-02), and
--Nassau County, N.Y. (1999-2000).
Some of the clusters involved as many as 18 deaths, and ranged from a rate of four to eight cases per million people.
A group of J.P. Morgan analysts issued an advisory last year on the impact the clusters could have on the beef industry, and said that some of the cases could be due to vCJD.
"The existence of clusters raises the question of 'contamination' or 'infection,' and also raises the hypothesis that rather than cases of sCJD, these might have been cases of vCJD," the advisory said. "Given that sCJD occurs randomly in one out of 1 million cases, it is a statistical rarity to find an sCJD cluster -- let alone six."
If that assessment is accurate, another cluster in Idaho would be even more unlikely.
Another possibility is some of the Idaho cases could be due to chronic wasting disease, which is similar to mad cow disease and currently is epidemic among deer and elk in several states, including Idaho's neighbors Wyoming and Utah.
No human cases of CWD have ever been confirmed, but the disease has been shown to infect human cells in a lab dish. Also, a team of researchers led by Jason Bartz of Creighton University in Omaha, Neb., report in the November issue of the Journal of Virology they had experimentally transmitted CWD to squirrel monkeys --the first reported transmission of CWD to primates.
If CWD is capable of infecting humans, it is unknown whether the resulting disease would resemble sCJD, vCJD or a novel disorder. If the disease looks like sCJD, cases could be going undetected or misdiagnosed.
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NIH may destroy human brain collection
By Steve MitchellMedical Correspondent
Washington, DC, Mar. 24 (UPI) -- The National Institutes of Health may discard part or all of a rare collection that includes hundreds of human brain samples from patients that suffered from a disorder similar to mad cow disease -- unless another researcher or institution takes them on, United Press International has learned.
Several scientists said the collection, which is held by the NIH's National Institute for Neurological Disorders and Stroke in Bethesda, Md. -- and includes brains and other tissue samples from people afflicted with the brain-wasting illness Creutzfeldt Jakob disease -- is irreplaceable and could even provide insight into treatments for the fatal disorder. Currently, there is no cure for CJD and patients typically die within a year after symptoms begin.
However, NIH officials in control of the collection's fate told UPI the remaining samples are of little scientific value and may be disposed of if researchers outside the agency do not claim it. That position stands in sharp contrast with CJD experts who thought the collection should be preserved.
"It's invaluable," said Dr. Paul Brown, former medical director of the NIH's Laboratory for Central Nervous System Studies, whose expertise is in CJD and mad cow disease (also known as bovine spongiform encephalopathy, or BSE).
The collection is badly in need of organization and no one is certain how many brains or other tissue samples it contains, said Brown, who worked with the collection since its inception in the 1960's until his retirement last year. There could be brains, blood, spinal fluid and various other tissues from 1,000 people or more, he said. Some of the specimens would be of scientific use today, he said.
"This collection has the unique value of stretching back to the beginning of when these diseases were discovered," Brown told UPI, noting that the first samples were obtained in 1963. "It would be as though you had in your hands the possibility of finding out when AIDS started."
Bruce Johnson, a former technician at the CNSS lab who worked extensively with the collection before he retired in 2003, told UPI he was told "in two years they (NIH officials)are going to destroy it, if nobody wants it."
Eugene Major, acting director of the basic neuroscience program at the NIH, said no specific timeframe had been established.
"We have not set a firm deadline date," Major told UPI. "We are working very hard with investigators that we know in order to be able to make sure that whatever we deem is valuable is potentially kept here." Some samples already have been determined not to have any research value and have been "removed and disposed of," he said.
Others samples have been given out to Dr. David Asher at the Food and Drug Administration and Pierluigi Gambetti at the National Prion Disease Pathology Surveillance Center in Cleveland, Ohio.
Major maintained the remaining collection was not particularly valuable for research. "Whatever had been collected here that has not already been distributed to responsible investigators who could use them really has very little remaining value," he said.
Neither Asher nor Gambetti returned phone calls from UPI, but Brown said he thought Asher had received only a dozen or two samples at most and Gambetti had not received much at all.
Neil Cashman, a brain-disease researcher at the University of Toronto's Center for Research in Neurodegenerative Diseases -- who has tried to obtain the collection from the NIH -- said it was priceless.
"It would be like destroying an art museum," Cashman told UPI. "There's all this information and insight that's locked up in these tissues and if it's destroyed it will be lost forever."
The Memorial Institute for Neurodegenerative Diseases Inc., a non-profit organization consisting of more than 40 university and institute researchers from the United States, Canada, United Kingdom and France, also thinks the brain collection is invaluable.
"It is the opinion of the Board of Directors ... of The MIND Inc., that the ... brain bank should not be broken up nor destroyed," said Harry E. Peery, MIND's executive director, in a letter to UPI. "We believe that this collection is of inestimable research value and should be kept intact."
The institute, at the University of Saskatchewan in Saskatoon, applied for possession of the collection in early 2004, but received a letter from the NINDS indicating the fate of the collection had not yet been determined.
"We have heard nothing further since that time" and continue to be interested in acquiring the complete collection, Peery said.
CJD belongs to a group of rare, brain-wasting disorders that are little understood, incurable and fatal. This includes mad cow disease in cows, chronic wasting disease in deer and elk. The most infamous of these illnesses in humans is variant CJD, which people can contract from eating beef products infected with the mad-cow pathogen.
Although vCJD has infected more than 154 people worldwide, only one case has ever been detected in the United States -- in a Florida woman who is thought to have contracted the disease while living in the United Kingdom. However, the NIH brain samples have never been screened for vCJD -- something Johnson thinks is critically important.
"No one has ever looked to see if any American (in the collection) in the past had variant CJD," Johnson said. "You think it would be required that they do that. You think it would be a Congressional mandate that they test these brains: 'Let's see if we've got this disease in our country.'"
Johnson noted at least one brain in the collection he personally had examined -- from a French woman collected in 1971 -- showed evidence of possible vCJD infection, but the sample needed further study to be sure.
Other samples in the collection include the brains of patients who were only 16 years old when they were diagnosed with CJD. This would be unusual for sporadic CJD, because generally it strikes those over age 60. Variant CJD, on the other hand, typically occurs in patients in their 20s or younger.
"I thought it was absolutely vital (to test these brains)," Johnson said. "Maybe there's a dozen cases in there of variant CJD."
Major disagreed. "There's really no reason to do that," he said. "The effort it would take to screen those samples ... would not give us any new insights into variant CJD beyond what it is we already know."
Johnson said he was frustrated with the NIH administration's lack of interest in preserving the collection or testing for vCJD. "They don't understand," he said, "they honest-to-god don't understand what it's all about."
Patient advocates also objected to the possible destruction of the brains.
Terry Singeltary, whose mother died of a type of CJD called Heidenhain variant in 1997, said he is outraged and families of other CJD victims probably will be, too.
"A lot of these families went through a lot of heartache and a lot of trouble to get these brain samples to the NIH," Singeltary told UPI. "Now they're just going to discard them because they're not of scientific use? That's just asinine. That stuff is valuable information."
Graham Steel, vice-chair of the Human BSE Foundation in the United Kingdom, told UPI, "The potential loss of such important tissue samples would be a massive blow for TSE (the group of diseases that includes CJD and BSE) research in the United States. This should not be allowed to happen."
Singeltary noted there currently is no cure for these diseases. "If you don't have any answers yet, why would you throw these specimens away?" he asked.
He added that more sensitive tests are just becoming available and could help determine the origin of some of the CJD cases. "We've all been sitting around waiting for more sensitive tests to get validated because we want answers," he said.
"You know, it must be an embarrassment," Johnson said. "Some Senator is going to eventually say 'What is NIH doing about mad cow disease?' And people are going to scratch their heads and say 'not much'." He added, "What's going to happen (is) one of these senators or their wife is going to develop spontaneous CJD one day and ... there's going to be hell raised and they're going to ask, 'Why isn't NIH working on this?'"
NIH sends mixed signals on CJD brains
By Steve MitchellMedical Correspondent
Washington, DC, Apr. 7 (UPI) -- A National Institutes of Health official who told United Press International the agency might destroy its collection of brains from human patients afflicted with a condition similar to mad cow disease reportedly has told the head of a patient-advocate group the collection would be preserved.
The official, Eugene Major, acting director of the basic neuroscience program at the NIH, has not responded to e-mail or a phone call from UPI seeking clarification of his remarks, and the official status of the collection remains unknown.
As reported by UPI on March 24, the collection is stored in freezers by the NIH's National Institute for Neurological Disorders and Stroke in Bethesda, Md. It contains brains and other tissue samples from hundreds of people who died from the brain-wasting illness Creutzfeldt Jakob disease, as well as tissues from an untold number of experimental animals.
The consensus of scientists in this field is the collection, which dates back to 1963, is invaluable for research and could even provide insight into treatments for the fatal disorder. Currently, there is no cure for CJD and patients typically die within a year after symptoms begin.
Florence Kranitz, president of the non-profit advocacy group CJD Foundation, told UPI she had "a very long conversation" with Major, in which he told her the remaining tissues in the collection would not be destroyed.
"He reassured me in no uncertain terms," Kranitz said, noting constituents of the foundation and other CJD advocacy groups had been expressing concerns to her the tissues would be destroyed.
Kranitz, who has personal reasons for wanting the collection preserved -- her husband died of CJD in 2000 -- said she plans to meet with Major at the end of April to discuss the issue further.
CJD belongs to a group of diseases collectively known as transmissible spongiform encephalopathies, or TSEs, that includes mad cow disease in cows, chronic wasting disease in deer and elk, and scrapie in sheep. All TSEs are incurable and fatal.
Major previously told UPI some samples already have been destroyed and others have been given to researchers at the Food and Drug Administration and the National Prion Disease Pathology Surveillance Center in Cleveland.
Major said the remaining collection "has very little remaining value" and could be destroyed if another entity does not claim them.
Bruce Johnson, a former NIH scientist who retired at the end of 2003, said he had been told the collection would be destroyed in two years if no one took the samples from the NIH.
In response to hearing that Major had failed to confirm to UPI the brain collection would not be destroyed, Patricia Ewanitz, who lives in Port Jefferson Station, N.Y., and is founder of the advocacy group CJD Voice, said, "The brain tissue might not be indispensable to the National Institutes of Health but it is absolutely necessary to the families who thought enough of science to donate the brains, brain tissue and blood in hopes of someday finding an answer to why their loved one died."
Ewanitz, whose husband died of CJD in 1997, added, "It now seems like such a joke."
Terry Singeltary, whose mother passed away from a type of CJD in 1997, said the NIH should use the samples for scientific research, not just store them in freezers.
Both Singeltary and Ewanitz said they would feel more reassured if Major verified in writing the collection will not be destroyed.
"I would go further and ask Major what he plans to do with them," Singeltary said. "If the samples are just going to sit up there and go bad, then they should give them out to researchers looking for cause and cure."
The revelation the NIH might destroy part or all of the collection sparked an outcry from patient advocates, consumer groups and scientists.
Advocates have been contacting their members of Congress, urging them to investigate and prevent the NIH from destroying the brains. Consumer groups also have gotten involved and scientists have taken steps to obtain the collection or have urged Major not to destroy the samples.
Felicia Nestor, who serves as a consultant to Public Citizen, told UPI she had contacted certain legislators and at least one was considering looking into the situation. Nestor asked the legislator's name be withheld.
Kranitz said Major also told her he plans "to advertise in professional neurological journals and by whatever means necessary to make it known" to researchers in the field the tissues are available.
Major previously said, however, that efforts to inform researchers of the availability of the collection were already underway and included informing NIH grantees. He added he had personally notified researchers at scientific meetings, but no TSE researcher contacted by UPI was aware of this.
"I was never informed," said Laura Manuelidis, an expert on these diseases and section chief of surgery in the neuropathology department at Yale University. She said the first she had heard of the situation was in UPI's March 24 report.
Manuelidis also said she contacted Major, expressing interest in the specimens, but so far has not received a response.
"I sent a letter to (Major) on (March 25) about our interest in these specimens, but he has not replied," she told UPI in an e-mail.
Neil Cashman, a TSE expert at the University of Toronto, who said he was not aware the samples might be destroyed, has lobbied colleagues at the University of British Columbia -- where Cashman is scheduled to move to this summer -- to help draft a letter requesting the collection.
The Memorial Institute for Neurodegenerative Diseases Inc., a non-profit organization consisting of more than 40 university and institute researchers from the United States, Canada, the United Kingdom and France, requested the collection in January, 2004. So far, the institute has not been informed of a decision by the NIH.
Asked if Major had told him whether the collection would be preserved, MIND Executive Director Harry Peery said, "We have heard nothing further from Eugene Major or anyone else at the NIH regarding the brain collection."
UNITED STATES SENATE
WASHINGTON, DC 20510-4305
Mr. Terry Singeltary
P.O. Box 42
Bacliff, Texas 77518
Dear Mr. Singeltary:In response to your recent request for my assistance, I have contacted the National Institutes ofHealth. I will write you again as soon as I receive a reply.I appreciate having the opportunity to represent you in the United States Senate and to be of service in this matter.Sincerely,
JOHN CORNYNUnited States SenatorJC:djl
UNITED STATES SENATE
WASHINGTON, DC 20510-4305
Mr. Terry Singeltary
P.O. Box 42
Bacliff, Texas 77518
Dear Mr. Singeltary:
Enclosed is the reply I received from the Department of Health and Human Services in response to my earlier inquiry on your behalf. I hope this will be useful to you.I appreciate having the opportunity to represent you in the United States Senate.
Thank you for taking time to contact me.
United States SenateJC:djlEnclosure
DEPARTMENT OF HEALTH & HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and StrokeNINDS
Building 31, Room 8A5231 Center Dr., MSC 2540Bethesda, Maryland 20892-2540Phone: 301-496-9746Fax: 301-496-0296Email: [log in to unmask]
May 10, 2005
The Honorable John CornynUnited States SenatorOccidental Tower5005 LBJ Freeway, Suite 1150Dallas, Texas 75244-6199
Dear Senator Cornyn:
Your letter to the National Institutes of Health (NIH) forwarding correspondence from Mr. Terry S. Singeltary, Sr., has been forwarded to me for reply. Mr. Singeltary is concerned about thepreservation of Creutzfeldt-Jakob disease (CJD) brain samples that have been maintained by theNational Institute of Neurological Disorders and Stroke (NINDS) Intramural Research programfor many years.
I am sorry to learn that Mr. Singeltary's mother died of CJD and can certainly understand hisdesire that any tissues that could help investigators unravel the puzzle of this deadly disease arepreserved. I hope he will be pleased to learn that all the brains and other tissues with potential tohelp scientists learn about CJD are, and will continue to be, conserved. (The tissues that arediscarded are those that have either decayed to an extent that renders them no longer appropriatefor research or those for which we do not have sufficient identification.)
The purpose of gathering these brains and tissues is to help scientists learn about CJD. To that end, some of the NINDS-held samples are distributed to investigators who can demonstrate thatthey have a compelling research or public health need for such materials. For example, sampleshave been transferred to NIH grantee Dr. Pierluigi Gambetti, who heads the National PrionDiseases Pathology Surveillance Center at Case Western Reserve University in Ohio and workswith the Centers for Disease Control and Prevention to monitor all cases of CJD in the UnitedStates. Dr. Gambetti studies the tissues to learn about the formation, physical and chemicalproperties, and pathogenic mechanisms of prion proteins, which are believed to be involved inthe cause of CJD. Samples have also been transferred to Dr. David Asher, at the U.S. Food andDrug Administration, for use in assessing a potential diagnostic test for CJD.
Page 2 - The Honorable John Cornyn
in closing, we know that donating organs and tissue from loved ones is a very difficult andpersonal choice that must often be made at the most stressful of times. We at the NINDS aregrateful to those stalwart family members who make this choice in the selfless hope that it willhelp others afflicted with CJD. We also know the invaluable contribution such donations maketo the advancement of medical science, and we are dedicated to the preservation of all of thetissue samples that can help in our efforts to overcome CJD.
I hope this information is helpful to you in responding to Mr. Singeltary.Sincerely,
Story C. Landis, Ph.D.Director, National Institute of Neurological Disorders and Stroke
NIH says it will preserve CJD brains
By STEVE MITCHELL
WASHINGTON, May 31 (UPI) -- The National Institutes of Health apparently has reversed its position on the fate of an invaluable collection of brains from people afflicted with a condition similar to mad cow disease, saying in a letter to a U.S. senator it will not destroy the collection.
An NIH official had told United Press International previously that the brain collection, which consists of samples from hundreds of people who died from the brain-wasting illness called Creutzfeldt Jakob disease, could be discarded if another entity does not claim them.
That sparked an outcry from patient-advocacy groups, consumer watchdogs and scientists, and the agency now appears to have backed away from that course.
"All the brains and other tissues with potential to help scientists learn about CJD are, and will continue to be, conserved," Story Landis, director of the National Institute of Neurological Disorders and Stroke, which oversees the brain collection, wrote in a May 10 letter to Sen. John Cornyn, R-Texas.
Cornyn had inquired about the status of the collection in April.
Last March, Eugene Major, acting director of the basic neuroscience program at the NIH, told UPI the useful portions of the collection had been doled out to scientists and the remaining samples had "very little remaining value" and could be destroyed.
Landis could not be reached for comment Tuesday. NINDS spokesman Paul Girolami told UPI he had been unable to locate her.
Scientists think the collection, which dates back to 1963, is invaluable for research on CJD and similar diseases and could even provide insight into treatments. There is no cure for CJD and patients typically die within a year after symptoms begin.
"Absolutely, the collection is worth keeping," Bruce Johnson, a former NIH scientist who said he had been told the collection would be destroyed in two years if no one took the samples from the agency, told UPI.
The Memorial Institute for Neurodegenerative Diseases Inc., a non-profit organization consisting of more than 40 researchers from several countries, offered to take the collection off of NIH's hands more than a year ago and so far has not heard anything from the agency, Harry Peery, MIND's executive director, told UPI.
CJD belongs to a group of incurable and fatal diseases collectively known as transmissible spongiform encephalopathies, or TSEs, that includes mad cow disease in cows, chronic wasting disease in deer and elk, and scrapie in sheep.
Variant CJD, or vCJD, is a relatively new TSE, which people can contract from consuming beef products infected with the mad cow pathogen.
Despite Landis' assurance the collection will be preserved, some family members of the patients who donated their brains to the NIH are still skeptical. This is because the wording Landis used in the letter leaves open the possibility that some brain samples are being destroyed.
"The tissues that are discarded are those that have either decayed to an extent that renders them no longer appropriate for research or those for which we do not have sufficient identification," Landis wrote.
"Which ones" are being destroyed? asked Terry Singeltary, who is involved with several CJD patient groups.
"With a system like this, they could destroy whatever and whenever they wanted, for whatever reason they wanted," Singeltary, whose mother died of CJD in 1997, told UPI.
"It's a perfect excuse to discard some suspicious tissue resembling vCJD or some atypical TSE related to animal TSEs in the USA," he added.
Although the collection includes samples from CJD patients as young as 16 that could make them candidates for possible vCJD, the brains have never been screened for evidence of the disease. The only confirmed vCJD case in the United States occurred in a Florida woman who is thought to have contracted the disease in England.
Johnson said he along with renowned CJD expert Paul Brown were in the process of sorting through the samples to match them up with patient identification documents until they both retired. Some of the samples may prove impossible to identify, he said, but he and Brown are the only ones familiar enough with the collection to organize it and neither has been asked back by the agency to aid in the identification process.
Steve Mitchell is UPI's Medical Correspondent. E-mail: [log in to unmask]
Copyright 2005 by United Press International. All Rights Reserved.
Subject: LESTER CRAWFORD AND THE FDA SOLD THERE SOUL TO THE DEVIL AND EXPOSED US ALL TO MAD COW DISEASEs I.E. TSE Date: January 20, 2007 at 8:53 am PST
Ex-FDA Chief Faces Fines in Stock Case By ANDREW BRIDGES, Associated Press Writer 1:55 PM PST, January 19, 2007
WASHINGTON -- Former FDA Commissioner Lester Crawford would face a $50,000 fine and probation but no jail time as punishment for lying about ownership of illegally held stocks, according to a deal worked out between his attorney and federal prosecutors.
Crawford and the government both have agreed to the fine and some form of probation, though his ultimate sentence will be at the discretion of Magistrate Judge Deborah A. Robinson, according to sentencing memoranda filed with the U.S. District Court in Washington.
His sentencing is set for Tuesday.
Crawford pleaded guilty in October to charges of having a conflict of interest and false reporting of information about stocks he and his wife owned in food, beverage and medical device companies he regulated while head of the Food and Drug Administration.
The U.S. Attorney's office recommended the $50,000 fine, saying it would exceed the roughly $39,000 Crawford and his wife, Cathy, made from exercising options and in dividends from the forbidden stocks they held in the FDA-regulated companies.
The government also recommended Crawford be sentenced to probation and community service but skip any jail time, according to its sentencing memo filed with the court. Crawford could face up to six months in jail under sentencing guidelines.
"Given his early acceptance of responsibility, the defendant's actions merit the stigma of criminal convictions, a fine, and probation, but not incarceration," according to the government memo, signed by assistant U.S. attorneys Howard R. Sklamberg and Timothy G. Lynch. Sklamberg declined to comment Friday.
Crawford's attorney, Barbara Van Gelder, said her client agreed to pay the fine, according to her memo to the court. However, Van Gelder specifically requested unsupervised probation, which would allow Crawford to travel overseas for work. Van Gelder did not mention community service in her memo. She did not immediately return a message seeking comment.
In October, Crawford admitted to falsely reporting that he had sold or did not own stock when he continued holding shares in the firms governed by rules of the FDA, which is illegal. Beginning in 2002, Crawford filed seven incorrect financial reports with a government ethics office and Congress, leading to the misdemeanor charges.
Although Crawford lied about ownership of the stocks -- including under oath before the Senate -- government attorneys acknowledged there is no evidence he was "engaged in a concerted scheme to use his high office for personal gain."
Van Gelder, meanwhile, suggested Crawford's wife, secretary and financial adviser prepared and handled the inaccurate financial statements Crawford filed with the government. She acknowledged, however, that Crawford remained ultimately responsible for their accuracy.
Crawford, a veterinarian and food-safety expert, abruptly resigned from the FDA in September 2005 but gave no reason for leaving. He had held the job for two months, following his confirmation by the Senate.
On the Net:
Food and Drug Administration: http://www.fda.gov/
FOR IMMEDIATE RELEASE P07-08 January 19, 2007 Media Inquiries: Kathleen Quinn, 301-827-6242 Consumer Inquiries: 888-INFO-FDA
FDA Commissioner Announces Important Personnel Changes
U.S. Food and Drug Administration (FDA) Commissioner Dr. Andrew C. von Eschenbach is pleased to announce two new personnel changes at the Agency; the creation of the Office of the Chief Medical Officer which will be overseen by Deputy Commissioner Dr. Janet Woodcock and the appointment of John R. Dyer, MPH, as the agency's Deputy Commissioner for Operations and the Chief Operating Officer (COO).
"FDA is a science-based agency and science-led Agency; science provides the foundation for our regulatory decisions and the work we do on a daily basis to promote and protect the nations' health," said Dr. von Eschenbach. "Creation of this office, and position, will better ensure we achieve this mission with the highest scientific quality and effectiveness needed."
Mr. Dyer most recently served as the Chief Operating Officer for the Centers for Medicare & Medicaid Services (CMS), a federal agency within the Department of Health and Human Services that is responsible for providing health insurance benefits to the elderly, disabled, and indigent through the Medicare and Medicaid programs. In that capacity, he led the implementation of the Medicare Modernization Act (MMA) and was responsible for the overall day to day operations of the agency. Specifically as COO, he helped develop the program policies and regulations, and stood up the business and systems operations of the prescription drug program in time for the congressionally mandated start of open enrollment on Oct 15, 2005 and start of the drug prescription benefits on January 1, 2006.
Prior to CMS, from 2001-2003, Mr. Dyer worked in the private sector for information technology and executive leadership companies. He was involved in entrepreneurial ventures in agriculture, real estate, and industrial enterprises in Latin America from 2003-2004.
In his federal career from 1972 to 2000, Mr. Dyer held increasingly responsible executive positions with the Social Security Administration (SSA), including the Chief Information Officer and Principal Deputy Commissioner where he assisted the agency by leading the effort to automate and modernize systems and improve the level of customer service. Other federal positions include the Director for Budget and Management at CMS (then the Health Care Financing Administration) from 1984-1998 and Commerce Branch Chief at the Office of Management and Budget in the Executive Office of the President. While at OMB, Mr. Dyer had budget and policy review of wide-ranging research and development programs ranging from mental health to ocean and atmospheric related.
Mr. Dyer has been the recipient of many awards during his federal career including the Presidential Award for Distinguished Executive. He holds a Masters Degree in Public Health from the University of Michigan and obtained his undergraduate Bachelor of Arts in Sociology from Notre Dame.
and this is science based ???
lester crawford sold his soul to the devil too $$$
lot of that going around with this administration, or so it seems.
now i know why it has taken so long to get any of the mad cow safe guards put into place, simply put, it was never about science. it was all about money and protecting the industries that are responsible for passing the mad cow agent to hell and back, and exposing us all, and killing some of our loved ones. i have always called it, 'corporate homicide', and these @ssholes make up laws as they go to protect themselves i.e. one example is the 'tissue donor law', where as after 4 hours of _attempting_ to contact the families of a deceased, if no contact is made, they can legally take tissue, without any concent, and then there are laws that protect them from getting sued for doing this. just one example that came off the top of my head, at least this is how it was in Texas last time i looked. to think that martha stewart went to prison and lester crawford walks. where is the justice, or is any justice left with this administration??? it is looking more and more like the bush administration was nothing more than a bunch of crooks. the majority of them anyhow. will it be more of the same with these new comers???
still very disgusted,
Subject: BSE FDA MAD COW SAFEGUARDS LESTER CRAWFORD SOLD OUT TO THE HIGHEST BIDDER Date: October 18, 2006 at 7:44 am PST
Former FDA Commissioner Pleads Guilty to Conflict of Interest and Making False Financial Disclosures
WASHINGTON, Oct. 17, 2006 - Lester M. Crawford, a former Commissioner of the Food and Drug Administration (FDA), has pled guilty to a Conflict of Interest charge and Making False Financial Disclosures to the U.S. Senate and the Executive Branch, announced U.S. Attorney Jeffrey A. Taylor and Inspector General Daniel Levinson, U.S. Department of Health and Human Services.
Crawford entered his guilty plea to the two misdemeanor charges this afternoon in the U.S. District Court for the District of Columbia before U.S. Magistrate Judge Deborah Robinson. Crawford is scheduled to be sentenced on January 22, 2007. He faces a sentence of up to one year in prison on each charge.
"One of the most important principles of our ethics laws is that public officials cannot have a financial interest in any decision that they make,” stated U.S. Attorney Taylor. “Lester Crawford, who held one of the most important jobs in government, blatantly violated these principles. Today, he is being held accountable for his actions."
Inspector General Levinson stated, "Any Government official's disregard of the conflict of interest laws undermines the integrity of the rules of conduct established for all those in Government. Taxpayers must have confidence that administrators of Government programs will be objective and free from improper influences in carrying out their official duties."
Crawford, 68, of Chevy Chase, Maryland, held some of the most senior positions in the FDA. He served as Deputy Commissioner between February 25, 2002 and March 26, 2004, when he became Acting Commissioner. On February 15, 2005, Crawford was nominated to become Commissioner. On July 18, 2005, the U.S. Senate confirmed Crawford, who remained Commissioner until September 30, 2005.
As a senior FDA employee, Crawford was required to file regular Public Financial Disclosure Reports, known as Standard Form SF 278s. Schedule A of the SF 278 required the filer to list all investment assets having a value exceeding $1,000 that were held by the filer or the filer's spouse, as well as sources of income exceeding $200 earned by the filer during the applicable reporting period.
Each year, ethics officials at the Department of Health and Human Services reviewed Crawford's SF 278s to ensure that he and his wife were not holding stocks or stock options of companies that were "significantly regulated organizations," which federal regulations defined as organizations for which the sales of products regulated by the FDA constitute ten percent or more of annual gross sales in the organization's previous fiscal year. Any FDA employee who was required to file an SF 278 could not hold a "financial interest," such as stock or stock options, in a significantly regulated organization.
Crawford's nomination as Commissioner required confirmation by the U.S. Senate and was considered by the Senate Committee on Health, Education, Labor, and Pensions. As a nominee, Crawford was required to submit two financial disclosure documents to the Committee: an SF 278 and a Statement for Completion by Presidential Nominees. Crawford filed both forms in February 2005.
Crawford’s plea to Making False Writings is based on his failure to disclose his and his wife’s ownership of stock in “significantly regulated organizations” to the Senate Committee and to the Executive Branch.
During the relevant time periods, Crawford and/or his wife owned forbidden stocks in the following “significantly regulated organizations”: Pepsico, Sysco, Kimberly-Clark, and Embrex.
Crawford filed a number of disclosure forms and other false writings in which he did not declare his and his wife’s ownership of forbidden stocks and stock options. Specifically,
•July 1, 2004. In this SF 278, Crawford disclosed ownership of Sysco and Kimberly-Clark stock. When an HHS ethics official inquired about Crawford’s ownership of this stock, Crawford responded in a December 28, 2004 email that the stocks in "Sysco and Kimberly-Clark have in fact been sold." That statement was false.
• February 23, 2005. Crawford did not disclose on this SF 278 his income from a November 17, 2004 exercise of Embrex stock options or the Crawfords' ownership of Kimberly-Clark or Sysco stock.
• February 25, 2005. Crawford failed to disclose in his nominee Statement to the Senate Committee his income from the exercise of Embrex stock options in October 2003 and November 2004. Crawford also did not disclose his remaining Embrex stock options.
Crawford’s ownership of Sysco and Pepsico stock and his role as Chairman of the FDA’s Obesity Working Group (“OWG”) gave rise to the Conflict of Interest charge, to which he has also pled guilty. On February 11, 2004, Crawford and the OWG's Vice Chairman submitted the OWG's final report and recommendations, entitled "Calories Count: Report of the Working Group on Obesity," to then-FDA Commissioner Mark McClellan. The report contained many recommendations, including encouraging manufacturers to re-label serving sizes, noting as an example that "a 20 oz bottle of soda that currently states 110 calories per serving and 2.5 servings per bottle could be labeled as 275 calories per bottle." The FDA publicly released "Calories Count" on March 12, 2004.
On June 3, 2004, Crawford testified before the House of Representatives Committee on Government Reform about the government's role in combating obesity. In his testimony, Crawford outlined the OWG's recommendations and again stressed the importance of re-labeling serving sizes for sodas.
During the entire period from the formation of the OWG to the date of Crawford's congressional testimony, Crawford and his wife owned 1,400 shares of Pepsico stock, worth a minimum of about $62,000, and 2,500 shares of Sysco stock, worth a minimum of about $78,000. Pepsico, a leading manufacturer of soft drinks and snack foods, and its shareholders had a financial interest in the OWG's conclusions and recommendations. Sysco, a leading manufacturer of food products, and its shareholders had a financial interest in the OWG's conclusions and recommendations.
There is no evidence that the OWG's conclusions were altered because of the Crawfords' ownership of Pepsico or Sysco stock.
Following the announcement of Crawford’s departure from office, Senators Mike Enzi and Edward Kennedy and Representatives Maurice Hinchey, Marcy Kaptur, Lynn Woolsey, Raúl Grijalva, and Sam Farr asked that the Inspector General investigate this matter.
In announcing today’s guilty plea, U.S. Attorney Taylor and Inspector General Levinson commended Inspector Thomas Sowinski of the Inspector General’s office for his outstanding investigation of this case. They also thanked the Senate Legal Counsel’s Office for the help that it provided in the investigation. Finally, they commended Assistant U.S. Attorneys Howard Sklamberg and Timothy Lynch, who prosecuted the case, and intern Vi Do, who assisted in the investigation.
For Information, Contact Public Affairs Channing Phillips (202) 514-6
like we have said time and time again, you cannot have the wolf guarding the henhouse. the fda, usda, aphis, fsis, cdc and nih, are just a few examples of how enept and or broken the system is. ...tss
Press Release FOR IMMEDIATE RELEASE Monday, Jan. 26, 2004 FDA Press Office 301-827-6242
Expanded "Mad Cow" Safeguards Announced to Strengthen Existing Firewalls Against BSE Transmission HHS Secretary Tommy G. Thompson today announced several new public health measures, to be implemented by the Food and Drug Administration (FDA), to strengthen significantly the multiple existing firewalls that protect Americans from exposure to the agent thought to cause bovine spongiform encephalopathy (BSE, also known as mad cow disease) and that help prevent the spread of BSE in U.S. cattle.
The existing multiple firewalls, developed by both the U.S. Department of Agriculture (USDA) and HHS, have been extremely effective in protecting the American consumer from exposure to BSE. The first firewall is based on import controls started in 1989. A second firewall is surveillance of the U.S. cattle population for the presence of BSE, a USDA firewall that led to the finding of the BSE cow in December. The third firewall is FDA's 1997 animal feed ban, which is the critical safeguard to help prevent the spread of BSE through cattle herds by prohibiting the feeding of most mammalian protein to ruminant animals, including cattle. The fourth firewall, recently announced by USDA, makes sure that no bovine tissues known to be at high risk for carrying the agent of BSE enter the human food supply regulated by USDA. The fifth firewall is effective response planning to contain the potential for any damage from a BSE positive animal, if one is discovered. This contingency response plan, which had been developed over the past several years, was initiated immediately upon the discovery of a BSE positive cow in Washington State December 23.
The new safeguards being announced today are science-based and further bolster these already effective safeguards.
Specifically, HHS intends to ban from human food (including dietary supplements), and cosmetics a wide range of bovine-derived material so that the same safeguards that protect Americans from exposure to the agent of BSE through meat products regulated by USDA also apply to food products that FDA regulates.
FDA will also prohibit certain currently allowed feeding and manufacturing practices involving feed for cattle and other ruminant animals. These additional measures will further strengthen FDA's 1997 "animal feed" rule.
"Today's actions will make strong public health protections against BSE even stronger," Secretary Thompson said. "Although the current animal feed rule provides a strong barrier against the further spread of BSE, we must never be satisfied with the status quo where the health and safety of our animals and our population is at stake. The science and our own experience and knowledge in this area are constantly evolving. Small as the risk may already be, this is the time to make sure the public is protected to the greatest extent possible."
"Today we are bolstering our BSE firewalls to protect the public," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "We are further strengthening our animal feed rule, and we are taking additional steps to further protect the public from being exposed to any potentially risky materials from cattle. FDA's vigorous inspection and enforcement program has helped us achieve a compliance rate of more than 99 percent with the feed ban rule, and we intend to increase our enforcement efforts to assure compliance with our enhanced regulations. Finally, we are continuing to assist in the development of new technologies that will help us in the future improve even further these BSE protections. With today's actions, FDA will be doing more than ever before to protect the public against BSE by eliminating additional potential sources of BSE exposure."
To implement these new protections, FDA will publish two interim final rules that will take effect immediately upon publication, although there will be an opportunity for public comment after publication.
The first interim final rule will ban the following materials from FDA-regulated human food, (including dietary supplements) and cosmetics:
Any material from "downer" cattle. ("Downer" cattle are animals that cannot walk.) Any material from "dead" cattle. ("Dead" cattle are cattle that die on the farm (i.e. before reaching the slaughter plant); Specified Risk Materials (SRMs) that are known to harbor the highest concentrations of the infectious agent for BSE, such as the brain, skull, eyes, and spinal cord of cattle 30 months or older, and a portion of the small intestine and tonsils from all cattle, regardless of their age or health; and The product known as mechanically separated beef, a product which may contain SRMs. Meat obtained by Advanced Meat Recovery (an automated system for cutting meat from bones), may be used since USDA regulations do not allow the presence of SRMs in this product. The second interim final rule is designed to lower even further the risk that cattle will be purposefully or inadvertently fed prohibited protein. It was the feeding of such protein to cattle that was the route of disease transmission that led to the BSE epidemic in United Kingdom cattle in the 1980's and 1990's.
This interim final rule will implement four specific changes in FDA's present animal feed rule. First, the rule will eliminate the present exemption in the feed rule that allows mammalian blood and blood products to be fed to other ruminants as a protein source. Recent scientific evidence suggests that blood can carry some infectivity for BSE.
Second, the rule will also ban the use of "poultry litter" as a feed ingredient for ruminant animals. Poultry litter consists of bedding, spilled feed, feathers, and fecal matter that are collected from living quarters where poultry is raised. This material is then used in cattle feed in some areas of the country where cattle and large poultry raising operations are located near each other. Poultry feed may legally contain protein that is prohibited in ruminant feed, such as bovine meat and bone meal. The concern is that spillage of poultry feed in the chicken house occurs and that poultry feed (which may contain protein prohibited in ruminant feed) is then collected as part of the "poultry litter" and added to ruminant feed.
Third, the rule will ban the use of "plate waste" as a feed ingredient for ruminants. Plate waste consists of uneaten meat and other meat scraps that are currently collected from some large restaurant operations and rendered into meat and bone meal for animal feed. The use of "plate waste" confounds FDA's ability to analyze ruminant feeds for the presence of prohibited proteins, compromising the Agency's ability to fully enforce the animal feed rule.
Fourth, the rule will further minimize the possibility of cross-contamination of ruminant and non-ruminant animal feed by requiring equipment, facilities or production lines to be dedicated to non-ruminant animal feeds if they use protein that is prohibited in ruminant feed. Currently, some equipment, facilities and production lines process or handle prohibited and non-prohibited materials and make both ruminant and non-ruminant feed -- a practice which could lead to cross-contamination.
To accompany these new measures designed to provide a further layer of protection against BSE, FDA will in 2004 step up its inspections of feed mills and renderers. FDA will itself conduct 2,800 inspections and will make its resources go even further by continuing to work with state agencies to fund 3,100 contract inspections of feed mill and renderers and other firms that handle animal feed and feed ingredients. Through partnerships with states, FDA will also receive data on 700 additional inspections, for a total of 3,800 state contract and partnership inspections in 2004 alone, including annual inspections of 100 percent of all known renderers and feed mills that process products containing materials prohibited in ruminant feed.
"We have worked hard with the rendering and animal feed production industries to try and achieve full compliance with the animal feed rule," said Dr. McClellan, "and through strong education and a vigorous enforcement campaign, backed by additional inspections and resources, we intend to maintain a high level of compliance."
Dr. McClellan also noted that, in response to finding a BSE positive cow in Washington state December 23, FDA inspected and traced products at 22 facilities related to that positive cow or products from the cow, including feed mills, farms, dairy farms, calf feeder lots, slaughter houses, meat processors, transfer stations, and shipping terminals. Moreover, FDA has conducted inspections at the rendering facilities that handled materials from the positive cow, and they were found to be fully in compliance with FDA's feed rule.
To further strengthen protections for Americans, FDA/HHS intends to work with Congress to consider proposals to assure that these important protective measures will be implemented as effectively as possible.
FDA is also continuing its efforts to assist in the development of better BSE science, to achieve the same or greater confidence in BSE protection at a lower cost. For example, to enhance the ability of our public health system to detect prohibited materials in animal feed, FDA will continue to support the development and evaluation of diagnostic tests to identify prohibited materials. These tests would offer a quick and reliable method of testing animal feeds for prohibited materials and for testing other products for contamination with the agent thought to cause BSE.
FDA has publicly discussed many of the measures being announced today with stakeholders in workshops, videoconferences, and public meetings. In addition, FDA published an Advance Notice of Proposed Rulemaking in November 2002 (available online at
concerning possible changes to the animal feed rule.
Comprehensive information about FDA's work on BSE and links to other related websites are available at http://www.fda.gov/.
For Immediate Release July 9, 2004 FSIS Press Office APHIS Press Office FDA Media Relations
(202) 720-9113 (202) 734-7799 (301) 827-6242
USDA and HHS Strengthen Safeguards Against Bovine Spongiform Encephalopathy WASHINGTON, July 9, 2004--HHS Secretary Tommy G. Thompson and Agriculture Secretary Ann M. Veneman today announced three actions being taken to further strengthen existing safeguards that protect consumers against the agent that causes bovine spongiform encephalopathy (BSE, also known as "mad cow disease").
The three documents on display today include:
A joint USDA Food Safety & Inspection Service (FSIS), USDA Animal and Plant Health Inspection Service (APHIS) and Food and Drug Administration (FDA) notice that asks for public comment on additional preventive actions that are being considered concerning BSE; An interim final FDA rule that prohibits the use of certain cattle-derived materials in human food (including dietary supplements) and cosmetics; and A proposed FDA rule on recordkeeping requirements for the interim final rule relating to this ban. "Today's actions continue our strong commitment to public health protections against BSE," Secretary Thompson said. "Although our current rules are strong, when it comes to public health and safety we cannot be content with the status quo. We must continue to make sure the public is protected to the greatest extent possible."
"This Administration is committed to science-based measures to enhance and protect public health," Veneman said. "The advance notice of proposed rulemaking will allow the public the opportunity to provide their input."
"The series of firewalls already in place offer excellent protection against BSE," said Acting Commissioner of the Food and Drug Administration, Dr. Lester M. Crawford. "With these additional measures, we will make a strong system even stronger by putting into effect the most comprehensive, science-based improvements possible."
The steps already taken have been effective in protecting the American consumer from exposure to BSE. Import controls on live cattle and certain ruminant products were put in place more than 15 years ago. In 1997, FDA finalized its animal feed ban, which has been the critical safeguard to stop the spread of BSE through the U.S. cattle population by prohibiting the feeding of most mammalian protein to cattle and other ruminant animals. USDA implemented additional measures in January to ensure that no cattle tissues known to be high risk for carrying the BSE agent are included in USDA-regulated products. Finally, as became evident last December, there is a contingency response plan, developed over the past several years, that is launched immediately to contain any potential damage after a BSE positive animal is found.
To allow interested parties and stakeholders the opportunity to comment on the additional regulatory and policy measures under consideration, USDA's APHIS and FSIS, along with the FDA, developed an advance notice of proposed rulemaking that includes several additional actions the federal government is considering regarding BSE.
The ANPR also provides the public a succinct report on the work of the international review team (IRT) convened by Secretary Veneman to review the U.S. response to the single case of BSE in the United States (in a cow imported from Canada), along with a summary of the many actions already taken by each agency on BSE.
USDA's FSIS continues to seek and address comments on actions taken in relation to the BSE mitigation measures and put in place in January 2004. FSIS is also specifically seeking comments on whether a country's BSE status should be taken into account when determining whether a country's meat inspection system is equivalent to the U.S. regulations including the provisions in the FSIS interim final rules.
USDA's APHIS is specifically seeking comments on the implementation of a national animal identification system. In April, USDA announced the availability of $18 million in Commodity Credit Corporation funding to expedite development of a national animal identification system, which is currently underway. APHIS is inviting comments on when and under what circumstances the program should move from voluntary to mandatory, and which species should be covered now and over the long term.
The ANPRM also requests comment on the following measures related to animal feed, which is regulated by FDA:
removing specified risk materials (SRM's) from all animal feed, including pet food, to control the risks of cross contamination throughout feed manufacture and distribution and on the farm due to misfeeding; requiring dedicated equipment or facilities for handling and storing feed and ingredients during manufacturing and transportation, to prevent cross contamination; prohibiting the use of all mammalian and poultry protein in ruminant feed, to prevent cross contamination; and prohibiting materials from non-ambulatory disabled cattle and dead stock from use in all animal feed. FDA has reached a preliminary conclusion that it should propose to remove SRM's from all animal feed and is currently working on a proposal to accomplish this goal. Comments on these issues raised in the ANPRM are due to FDA next month.
FDA today also issued an interim final rule that prohibits the use of cattle-derived materials that can carry the BSE-infectious agent in human foods, including certain meat-based products and dietary supplements, and in cosmetics. These highÇrisk cattle-derived materials include SRM's that are known to harbor concentrations of the infectious agent for BSE, such as the brain, skull, eyes, and spinal cord of cattle 30 months of age or older, and a portion of the small intestine and tonsils from all cattle, regardless of their age. Prohibited high-risk bovine materials also include material from non-ambulatory disabled cattle, the small intestine of all cattle, material from cattle not inspected and passed for human consumption, and mechanically separated beef.
This action is consistent with the recent interim final rule issued by USDA declaring these materials to be inedible (unfit for human food) and prohibiting their use as human food.
FDA's interim final rule, in conjunction with interim final rules issued by FSIS in January 2004, will minimize human exposure to materials that scientific studies have demonstrated are likely to contain the BSE agent when derived from cattle that are infected with the disease. Consumption of products contaminated with the agent that causes BSE is the likely cause of a similar disease in people called variant Creutzfeldt-Jakob disease.
Although FDA's interim final rule has the full force and effect of law and takes effect immediately upon publication in the Federal Register, FDA is also asking for public comment on it.
In conjunction with the publication of the interim final rule, FDA is also proposing to require that manufacturers and processors of FDA-regulated human food and cosmetics containing cattle-derived material maintain records showing that prohibited materials are not used in their products. FDA is taking this action because records documenting the absence of such materials are important to ensure compliance with requirements of the interim final rule.
Publication of this USDA-FDA notice, as well as the two FDA documents, is scheduled for mid-July in the Federal Register. Comments should be submitted as directed in the addresses section of each document. Each document also provides information about how and where comments received may be viewed.
Note to Reporters: USDA news releases, program announcements and media advisories are available on the Internet. Go to the APHIS home page at http://www.aphis.usda.gov/ and click on the "News" button.
HHS news releases are available online at http://www.hhs.gov/; FDA news releases can be found at http://www.fda.gov/, which will also provide links to the documents discussed in this release.
STATEMENT BY LESTER M. CRAWFORD, D.V.M., PH.D. DEPUTY COMMISSIONER OF FOOD AND DRUGS DEPARTMENT OF HEALTH AND HUMAN SERVICES BEFORE THE COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY UNITED STATES SENATE JANUARY 27, 2004
Mr. Chairman, Members of the Committee, thank you for the opportunity to participate in today’s hearing on measures taken by the Federal government to safeguard human and animal health in the United States from Bovine Spongiform Encephalopathy (BSE) and the response to the finding of a BSE-positive cow in the State of Washington. I am Dr. Lester M. Crawford, Deputy Commissioner, Food and Drug Administration (FDA or the Agency).
The mission of FDA is to protect the public health by assuring the safety and efficacy of our nation’s human and veterinary drugs, human biological products, medical devices, human and animal food supply, cosmetics, and radiation emitting products. In fulfilling this mission, FDA is the Agency responsible for assuring that all FDA-regulated products remain safe and uncompromised from BSE and related diseases. Many FDA-regulated products contain bovine ingredients, for example, heart valves, ophthalmic devices, dental products, wound dressings, injectable drugs, vaccines, soups, gravies, sausage casings, and animal feeds.
FDA has long been actively involved nationally and internationally in efforts to understand and prevent the spread of BSE. FDA collaborates extensively with the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Animal and Plant Health Inspection Service (APHIS) and the Food Safety and Inspection Service (FSIS) within the U.S. Department of Agriculture (USDA), Customs and Border Protection (CBP), the Environmental Protection Agency (EPA), other Federal agencies, state and local jurisdictions, and with affected industries and consumer groups. Many of these activities fit within the framework of the Department of Health and Human Service’s (HHS or the Department) Bovine Spongiform Encephalopathy/Transmissible Spongiform Encephalopathy (BSE/TSE) Action Plan, which was released in August 2001. This collaboration over many years has enabled FDA to strengthen safeguards for FDA-regulated products and to respond quickly and effectively to the first case of BSE within the U.S.
The mission of the Agency is to protect the public health by assuring the safety and efficacy of our nation’s human and veterinary drugs, human biological products, medical devices, human and animal food supply, cosmetics, and radiation emitting products. In fulfilling this mission, FDA is the Agency responsible for assuring that all FDA-regulated products remain safe and uncompromised from BSE and related diseases.
BSE is a progressive neurological disorder of cattle that results from infection by an unconventional transmissible agent, and was first diagnosed in the United Kingdom (U.K.) in 1986. Many FDA-regulated products contain bovine ingredients, for example, heart valves, ophthalmic devices, dental products, wound dressings, injectable drugs, vaccines, soups, gravies, sausage casings, and animal feeds and thus must be taken into consideration as part the effort to prevent infectivity by BSE.
FDA has a longstanding commitment to protecting consumers from BSE by following multiple measures designed to safeguard FDA-regulated products from possible contamination by the BSE agent. Under the Federal Food, Drug, and Cosmetic (FD&C) Act, FDA has the authority to prevent the adulteration and misbranding of FDA-regulated products. Further, for medical products that require pre-market approval (e.g., drugs under Section 505 and medical devices under Section 513 of the FD&C Act), FDA has addressed safety concerns related to BSE through requirements of the application and approval process.
The U.S. employs a robust multi-layered approach to preventing the introduction and amplification of BSE. While the goal of this approach is to achieve an extremely high level of compliance with each preventative measure, this multi-layered approach is designed to protect the U.S. consumer from exposure to the BSE infective material, and to date this approach has been working. Since 1989, USDA has prohibited the importation of live animals and animal products from BSE-positive countries. Since 1997, FDA has prohibited the use of certain mammalian proteins in the manufacture of ruminant feed. FDA continues to implement policies to keep safe all FDA-regulated products, including food, food ingredients, dietary supplements, drugs, vaccines, and cosmetics from risk of any BSE-contaminated bovine material. As a result of these multiple regulatory safeguards, the risk of exposure to BSE through products, FDA regulates remains extremely low in the U.S.
FDA’s 1997 animal feed regulation forms the basis of the Agency’s efforts to prevent the spread of BSE through animal feed. This rule prohibits the use of most mammalian protein in the manufacture of animal feeds for ruminants. FDA implemented this rule to establish in our country feeding practices consistent with the best science and epidemiological knowledge known at the time to prevent the spread of BSE throughout herds of U.S. cattle. A risk assessment sponsored by USDA and conducted by the Harvard Center for Risk Analysis, released in November 2001, identified FDA’s feed ban as one of the primary safeguards against the spread of BSE in U.S. cattle.
To maximize protection afforded by the feed regulation, FDA has developed and implemented a BSE/Ruminant Feed Ban Inspection compliance program and established the goal of 100 percent compliance. FDA’s strategy for achieving uniform compliance with the feed rule focuses on three areas: education, inspection, and enforcement. FDA and its state counterparts conduct, at least annually, targeted BSE inspections of 100 percent of known renderers, protein blenders, and feed mills processing products containing material prohibited from use in ruminant feed. Compliance by these establishments with FDA’s feed rule is estimated to be at better than 99 percent. As of December 20, 2003, FDA had received over 26,000 inspection reports (6,404 for Fiscal Year 2003). The majority of these inspections (around 70 percent) were conducted by state officials for FDA, with the remainder conducted by FDA officials. The total number of inspection reports represents 13,672 firms, 1,949 of which are active and handle materials prohibited from use in ruminant feed. The 1,949 active firms that handle prohibited material have been inspected by FDA and, as of December 31, 2003, only five were found to have significant violations, resulting in official action indicated (OAI). FDA is working with these firms to bring them into compliance.
On December 23, 2003, FDA was notified by USDA of a presumptive-positive finding of BSE in a cow in Washington State. FDA immediately initiated its BSE Emergency Response Plan. As part of the plan, FDA has been coordinately closely with USDA so that we can effectively investigate this BSE case, trace the various products involved, and take the appropriate steps to protect the public. FDA investigators and inspectors located the high risk material rendered from the infected cow, and the rendering plants placed a hold on the rendered material, which is being disposed of appropriately. I am happy to report that all of the establishments inspected by FDA during the course of the investigation were in compliance with the feed ban. In addition, to help address the concerns of foreign governments and restore confidence in American products, FDA has participated, along with USDA, in numerous meetings and consultations with foreign governments since USDA surveillance found the BSE-positive cow.
In addition to new policies and regulations, new knowledge and tools gained through applied research can greatly help us to be more effective in our regulatory mission, such as protecting the country from BSE. Several of FDA’s Centers, as well as many private laboratories, academic institutions, and other Federal agencies (most notably NIH) are also involved in significant research activities relating to TSEs. Basic areas requiring research include: increasing our understanding of prions, learning how prions are transmitted within a species and potentially between species, developing diagnostic tests for humans and animals, developing detection methods for use on regulated products, developing methods to increase or eliminate infectivity, and designing new treatments. We are optimistic about the promise of new technologies, such as better methods to quickly distinguish the species of proteins and sensors to detect abnormal prions in food. Development of these technologies can contribute significantly to the effort to prevent the spread of BSE and must be considered carefully when evaluating potential regulatory changes to address BSE.
At the time that FDA implemented the feed rule in 1997, the Agency also recognized that evolving, complex scientific and public health issues, particularly regarding BSE required the Agency to continue to assess and scrutinize the rule to ensure its integrity as a firewall against the potential for spread of BSE. To further explore ways the animal feed regulation could be improved in November 2002, FDA published an advance notice of proposed rulemaking (ANPR) soliciting information and views from the affected industries and the public on some potential changes to its current feed regulation, including ways that the animal feed regulation could be strengthened. Although the risk of exposure to BSE in the U.S. remains extremely low and the measures in place are working, as a result of the recently discovered infected cow in the state of Washington, the Agency is evaluating the appropriateness of additional science-based measures to further strengthen our current protections.
Yesterday, Department Secretary Tommy Thompson and FDA Commissioner Mark McClellan announced several additional public health measures to further strengthen the current robust safeguards that help protect Americans from exposure to the agent that causes BSE and help prevent the spread of BSE in U.S. cattle. These measures relate to both protections for foods intended for human consumption as well as additional measures to strengthen FDA’s 1997 final rule regulating animal feed. With respect to human foods, FDA announced that it will extend to FDA-regulated foods, dietary supplements and cosmetics, restrictions on using specified risk materials that would complement the recent USDA announcements. Concerning animal feed, the Agency announced a series of measures designed to lower even further the risk that cattle will be purposefully or inadvertently fed “ruminant” proteins, including, eliminating an exemption in the feed rule that allows mammalian blood and blood products at slaughter to be fed to ruminants as a protein source; banning the use of “poultry litter” as a feed ingredient for cattle and other ruminants; prohibiting the use of “plate waste” as a feed ingredient for ruminants, including cattle; and taking steps to further minimize the possibility of cross-contamination of animal feed via equipment, facilities or production lines.
Finally, FDA is increasing its inspections of feed mills and renderers in 2004. Our 2001 base funding for BSE-related activities was $3.8 million. We shifted resources internally in 2001 and received a substantial increase from Congress in 2002. Our funded level for 2004 is currently approximately $21.5 million, almost a five-fold increase over the 2001 base. FDA will itself conduct 2,800 inspections and will make its resources go even further by working with state agencies to fund 3,100 contract inspections of feed mills and renderers and other firms that handle animal feed and feed ingredients. Through partnerships with states, FDA will also receive data on 700 additional inspections, for a total of 3,800 state contract and partnership inspections in 2004. These inspections would include 100 percent of all known renderers and feed mills that process products containing prohibited materials.
The Agency looks forward to continuing to assist Congress as it evaluates the risks associated with BSE, identifies opportunities to promote technologies that will detect and prevent the spread of BSE, and considers science-based approaches to further strengthen regulatory protections and bolster the resources available to assist Federal, state, local and private efforts to assure that BSE does not present a threat to human or animal health in the U.S.
Background on Bovine Spongiform Encephalopathy (BSE)
BSE is a progressive neurological disorder of cattle that results from infection by an unconventional transmissible agent, and was first diagnosed in the U.K. in 1986. It belongs to a family of diseases, transmissible spongiform encephalopathies (TSEs), a group of transmissible, slowly progressive, degenerative diseases of the central nervous systems of several species of animals.
The vast majority of BSE cases have been reported in the U.K., where more than 183,000 cases in more than 35,000 herds have been reported through the end of November 2003. The U.K.-BSE epidemic peaked in January 1993 at nearly 1,000 new cases per week. The original source of the BSE outbreak is uncertain, but may have resulted from the feeding of scrapie-containing sheep meat-and-bone meal to cattle. Scrapie is an endemic spongiform encephalopathy and has been widespread in the U.K., where the rendered carcasses of livestock (including sheep) were fed to ruminants and other animals until 1988, as a protein-rich nutritional supplement. It appears likely that changes in the rendering process in the U.K. that had taken place around 1980 allowed the etiologic agent in infected carcasses to survive, contaminate the protein supplement, and infect cattle. There is strong evidence and widespread agreement that the outbreak was amplified by feeding rendered bovine meat-and-bone meal to young calves. BSE has a prolonged incubation period in cattle, ranging from two to eight years, with a mean of five to six years.
Outside of the U.K., 22 other countries, mostly in Europe, have reported cases of BSE in indigenous cattle to the World Organisation for Animal Health (known as the O.I.E.). Other countries may be considered at risk because of an inadequate surveillance program, a lack of information on which to make a risk assessment, or the potential for exposure to BSE.
TSEs also include “scrapie” in sheep and goats, “chronic wasting disease” (CWD) in deer and elk, feline spongiform encephalopathy, transmissible mink encephalopathy, and, in humans, kuru, Gerstmann-Straussler-Scheinker syndrome, fatal familial insomnia, and Creutzfeldt-Jakob disease (CJD or “classical” CJD) and variant CJD, which was first reported in the U.K. in 1996. TSEs are not known to infect non-mammalian species.
Classic CJD occurs throughout the world, including the U.S., at a rate of about one case per million people. The median age at death in the U.S. of patients with classic CJD is 68. Most cases of CJD are considered sporadic, a small number are familial associated with a gene mutation, and a small number are iatrogenic, resulting from the accidental transmission of the causative agent via contaminated surgical equipment, or as a result of cornea or dura mater transplants, or the administration of human-derived pituitary growth hormones.
Variant CJD (vCJD) is a distinct variant from classic CJD and is strongly believed to have been acquired from eating food products containing the BSE agent. The absence of confirmed cases of vCJD in geographic areas free of BSE supports this conclusion, and the interval between the period for initial extended exposure of the population to potentially BSE-contaminated food and the onset of initial vCJD cases, approximately ten years, is consistent with known incubation periods for CJD. Experimental studies on monkeys and mice, as well as additional laboratory studies of infecting prions from vCJD patients and BSE-infected animals, also support such a relationship. The incubation period for vCJD in humans is unknown, but is at least five years and could extend up to 20 years or longer.
As of December 1, 2003, a total of 153 vCJD cases had been reported worldwide, 143 of the cases occurring in the U.K. The low number of vCJD cases relative to the number of cases of BSE in the U.K. indicates that a substantial species barrier protects humans from widespread illness. There are no cases of vCJD having been contracted in the U.S. The only person diagnosed with vCJD while living in the U.S. is a U.K. citizen believed to have acquired the disease while living in the U.K.
Legal and Regulatory Framework for FDA Protections
FDA has a longstanding commitment to protecting consumers from BSE by following multiple measures designed to safeguard FDA-regulated products from possible contamination by the BSE agent. Under the FD&C Act, FDA has the authority to prevent the adulteration and misbranding of FDA-regulated products. For example, FDA has used provisions in Section 402(a) (the food adulteration provisions) and Section 403(a) (the food misbranding provisions) of the FD&C Act to prohibit ruminant feed from containing certain protein derived from mammalian tissues. These same adulteration and misbranding provisions apply to human food. Further, for medical products that require pre-market approval (e.g., drugs under Section 505 and medical devices under Section 513 of the FD&C Act), FDA has addressed safety concerns related to BSE through requirements of the application and approval process. Additionally, when material from the one BSE-positive cow in the U.S. was traced to renderers, FDA advised those firms that this material could not be used as an animal feed because it was adulterated under Section 402(a)(5) of the FD&C Act because it was, in part, the product of a diseased animal. Under section 801 of the FD&C Act, FDA may refuse admission of imported food and certain other products that appear to be in violation of the FD&C Act. Furthermore, under Section 701(a), FDA may promulgate regulations for the efficient enforcement of the FD&C Act. For example, under Section 701(a) and other sections, FDA promulgated its “animal feed” rule (Title 21, Code of Federal Regulation (CFR) section 589.2000) to prohibit ruminant feed from containing certain protein derived from mammalian tissues. In addition, under the Public Health Service Act, FDA is authorized to make and enforce regulations to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the U.S. or between states.
Preventing the Spread of BSE: FDA Protections
FDA and other Federal agencies have had preventive measures in place to reduce the U.S. consumer’s risk of exposure to any BSE-contaminated meat and food products for a considerable time. Since 1989, USDA has prohibited the importation of live animals and animal products from BSE-at risk countries. Since 1997, FDA has prohibited the use of certain mammalian proteins in the manufacture of ruminant feed. FDA continues to implement policies to keep safe all FDA-regulated products, including food, food ingredients, dietary supplements, drugs, vaccines, and cosmetics from risk of any BSE-contaminated bovine material. As a result of these multiple regulatory safeguards, the risk of exposure to the BSE agent through products FDA regulates remains extremely low in the U.S. In 1998, USDA commissioned the Harvard Center for Risk Analysis to conduct an analysis and evaluation of the U.S. regulatory measures to prevent the spread of BSE in the U.S. and to reduce the potential exposure of U.S. consumers to BSE. The Harvard study concluded, among other things, that even if introduced in the U.S., due to the preventive measures currently in place in the U.S., BSE is extremely unlikely to become established in the U.S.
The U.S. employs a robust approach to preventing the introduction and amplification of BSE, and the prevention of introduction and amplification of BSE has been described as consisting of five separate firewalls. Our existing firewalls are based on a four-pronged regulatory strategy:
Our first firewall is formed through regulations and enforcement to protect U.S. borders from potentially infective materials utilizing a regime of import controls. USDA, beginning in 1989, enacted major restrictions on imports, and more restrictive import controls have been introduced as we have learned more about the science of BSE and as the worldwide epidemiology has changed. FDA remains a committed partner with USDA and CBP in protecting our borders. The second firewall is surveillance of the U.S. cattle population for the presence of BSE. Surveillance of the cattle population is the primary responsibility of USDA, and USDA has recently announced steps to increase surveillance. The third firewall is prevention of the amplification of BSE through feed provided to cattle and other ruminants, and this responsibility falls primarily on FDA. FDA’s animal feed ban regulations form the basis of this third firewall and have been cited as one of the most significant elements needed to prevent the spread of BSE in the U.S. We have taken intensive steps to get an extremely high level of compliance with this feed ban. As a result, we have been able to work with the animal feed industry to achieve more than a 99% compliance rate – and we intend to continue to work for full compliance. The fourth firewall is making sure that no bovine materials that can transmit BSE be consumed by people. So even if a BSE-positive cow made it through all of the previous firewalls, which is extremely unlikely, it would not pose any risk to people. USDA and FDA have long had steps in place to help prevent any possible exposure to BSE in bovine products, and recently USDA announced additional major steps to prevent any of the tissues known to carry BSE from entering the beef supply, as well as to restrict use of certain “downer” cows that might be at higher risk of carrying BSE. FDA will be taking comparable measures to prevent human exposure to the FDA-regulated bovine products that might potentially harbor BSE. A fifth firewall is effective response planning to contain the potential for any damage from a BSE positive animal, if one is discovered at some point in the system. This urgent response plan went into place immediately upon the discovery of a BSE-positive cow in Washington State on December 23, 2003. We have inspected and traced products at 22 facilities, including feed mills, farms, dairy farms, calf feeder lots, slaughterhouses, meat processors, transfer stations, and shipping terminals. We have accounted for all the products related to the BSE-positive cow that FDA regulates, and none have gone into human or animal consumption. Moreover, FDA has conducted inspections at all the rendering facilities involved, and found they were fully in compliance with our feed rule. The goal of our firewall after firewall approach is to provide full protection of the public against BSE without adding unnecessary costs or restricting the consumption of safe beef products. FDA and USDA intend to maintain an extremely high level of compliance with each firewall. In addition, our multi-layered approach makes sure that even if each firewall doesn’t function perfectly, the U.S. consumer is, nonetheless, protected from exposure to the BSE infective material.
FDA’s Feed Rule: Substances Prohibited From Use in Animal Feed
Rendered feed ingredients contaminated with the BSE agent are believed to be the principal means by which BSE is amplified in cattle populations. To help prevent the establishment and spread of BSE through feed in the U.S., FDA implemented a final rule that prohibits the use of most mammalian protein in the manufacture of animal feeds for ruminants. This rule, 21 CFR 589.200, became effective on August 4, 1997. Mammalian proteins exempted from the rule are blood and blood products, gelatin, inspected meat products that have been cooked and offered for human food and further heat processed for feed (such as plate waste and used cellulosic food casings), milk products (milk and milk proteins), and any product whose only mammalian protein consists entirely of porcine or equine protein. Fats and oils, such as tallow, do not fall within the current feed rule because they are not protein.
FDA implemented this rule to establish in our country feeding practices consistent with the best science and epidemiological knowledge known at the time to prevent the spread of BSE throughout herds of U.S. cattle. A risk assessment sponsored by USDA and conducted by the Harvard Center for Risk Analysis, released in November 2001, identified FDA’s feed ban as one of the primary safeguards against the spread of BSE in U.S. cattle.
To maximize protection afforded by the feed regulation, FDA has developed and implemented a BSE/Ruminant Feed Ban Inspection compliance program and established the goal of 100 percent compliance. FDA’s strategy for achieving uniform compliance with the feed rule focuses on three areas: education, inspection, and enforcement.
A strong inspection presence can be considered the backbone of FDA’s strategy for achieving compliance with the feed rule. FDA and its state counterparts conduct, at least annually, targeted BSE inspections of 100 percent of known renderers, protein blenders, and feed mills processing products containing material prohibited from use in ruminant feed. Compliance by these establishments with FDA’s 1997 feed rule is over 99 percent. FDA has prioritized the inspection process so that any firms found to be out of compliance in their last inspection will be promptly re-inspected. In addition, FDA will conduct for-cause inspections where evidence dictates, e.g., as a result of a sampling assignment. FDA and the states also conduct inspections of selected processors that are not using prohibited material to ensure compliance with the regulation by this segment of the industry.
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 decisions are reported as 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 the ruminant feed rule such as minor record-keeping 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. As of December 20, 2003, FDA had received over 26,000 inspection reports (6,404 for fiscal year 2003). The majority of these inspections (around 70 percent) were conducted by state officials for FDA, with the remainder conducted by FDA officials. The total number of inspection reports represents 13,672 firms, 1,949 of which are active and handle materials prohibited from use in ruminant feed. These firms, which may be in more than one category, include renderers, licensed feed mills, feed mills not licensed by FDA, protein blenders, and others (such as ruminant feeders, on-farm mixers, pet food manufacturers, animal feed salvagers, distributors, retailers, and animal feed transporters). The 1,949 active firms that handle prohibited material have been inspected by FDA and, as of December 31, 2003, only five were found to have significant violations, resulting in OAI. FDA is working with these firms to bring them into compliance.
To be transparent about inspection results, FDA has recorded inspectional findings in a newly designed FDA BSE/Ruminant Feed Inspection Database available on FDA’s website. The database is dynamic, with new information being entered on a continual basis. Each entry in the database represents the results of the most recent inspection.
FDA also conducts sampling of feed and feed ingredients in the marketplace as an additional tool to target firms for inspection. This type of sample analysis is being done using feed microscopy as the method for detecting prohibited materials. Other methods, such as polymerase chain reaction (PCR), are being validated for additional analytical use.
Enforcement is an important component of the compliance strategy. FDA pursues enforcement actions when we find knowing or intentional non-compliance, or if repeated inspection and educational efforts are ineffective in assuring compliance. Our first action of choice will ordinarily be a Warning Letter, which notifies responsible parties of a violation or violations and asks for a response within a certain time frame explaining corrective actions taken. When it is consistent with the public protection responsibilities of FDA and the nature of the violation, it is our practice to afford individuals and firms an opportunity voluntarily to take appropriate and prompt corrective action. The Agency has additional, more stringent enforcement tools available when our notification to the company of documented violations does not lead to compliance with the FD&C Act, including product seizure, injunction, and prosecution.
As of January 1, 2004, FDA has issued 63 Warning Letters and has one court ordered Permanent Injunction since the BSE feed rule went into effect. Also, 47 firms recalled 280 products during the same time period; 12 of the recalls were in 2003.
Education has been, and continues to be, a critical component of our compliance strategy. Providing clear guidance and information on FDA’s requirements and regulations is vital to help assure compliance. FDA has provided and sponsored many educational services and forums, including nationwide seminars, CD-ROM training, teleconferences, guidances targeted for different segments of the animal feed industry, guidance for Federal and state inspectors, and a variety of published articles. The Agency has met with many industry trade groups to discuss coordination of educational efforts with affected parties, and we expect to continue an open dialogue, seeking suggestions for types of educational approaches, sharing resources, and keeping the industry updated on new developments or problem areas that arise.
To minimize the risk of the introduction or spread of BSE we also must have strong enforcement measures to protect our borders. FDA’s Import Program is responsible for coordinating the import of products potentially infected with or at high risk of infection with the agent associated with BSE. Operationally, FDA’s Import Program provides for the review of information about FDA-regulated products offered for entry into the U.S. and the opportunity for physical examination of the products. FDA uses this information to determine whether a product is subject to refusal of admission.
In protecting the borders from potentially unsafe products, FDA works closely with USDA and CBP to ensure a coordinated and efficient BSE import control strategy. This tri-agency cooperative effort has led to a multi-layer review process whereby each agency utilizes the strengths of its particular entry procedures to produce a composite system that is considerably more robust than any one component. BSE import activities are reviewed and coordinated by an inter-agency workgroup composed of representatives from FDA, CBP, and USDA/APHIS. In fact, on February 5, 2002, with APHIS, FSIS, Canadian Food Inspection Agency (CFIA), Health Canada, and state participation, FDA conducted a simulation exercise involving the importation of potentially BSE-contaminated product and subsequent regulatory follow-up.
FDA uses Import Alerts to disseminate information regarding problems or potential problems with imported products. Import Alerts recommend that field offices examine, sample, or detain and, if warranted, refuse admission of the product in question. These Import Alerts are made available on FDA’s website. With respect to its import alerts on BSE, FDA coordinates closely with APHIS and its prohibitions on the importation of products related to BSE concerns. An alert may cover an individual manufacturer, supplier, or a particular product from an entire country. Import Alerts also may be issued as a follow-up to an inspection, when it is determined that a manufacturer is in violation of good manufacturing practice requirements.
FDA has in place several import alerts targeting BSE. Import Alert 17-04, first issued in October 1994, allows detention, without physical examination, of bulk shipments of high-risk bovine tissues and tissue-derived ingredients from BSE-at-risk countries. Import Alert 99-25, first issued in January 2001, allows detention without physical examination of animal feed, animal feed ingredients, and other products for animal use from countries identified by USDA as BSE-positive or BSE-at-risk when processed animal protein is declared in the ingredients or when FDA sampling and analysis finds the presence of undeclared animal protein. Import Alert 71-02, issued in October 2003, calls for detention without physical examination of products of specific firms located in USDA-listed BSE-positive or BSE-at-risk countries, which have been identified through FDA sampling and analysis, as importing products containing animal protein. These import alerts are continuously updated as new countries are listed by USDA as either BSE-positive or BSE-at-risk, or to make other appropriate changes.
FDA’s Response to the Identification of a BSE-Positive Cow in Washington State
On December 23, 2003, at approximately 3:00 pm, the Agency’s Office of Crisis Management (OCM) was notified by USDA’s APHIS of a presumptive-positive finding of bovine spongiform encephalopathy (BSE) in a “downer” cow slaughtered on December 9, 2003, at a USDA-inspected slaughter facility in Washington State.
FDA had in place its Bovine Spongiform Encephalopathy Emergency Response Plan that describes the roles and activities of each of the Agency components involved in managing this kind of emergency. This plan had been tested several times in tabletop and simulated incidents that actively involved state, Federal, and Canadian counterparts. The plan has been in place since 2001 and has been revised in response to the incident exercises conducted by FDA.
As provided in the Emergency Response Plan, OCM’s Emergency Operations Center (EOC) is the single point of coordination for FDA’s response to a BSE emergency. FDA’s EOC maintains contact with HHS Secretary’s Command Center (SCC), CDC’s EOC, USDA/FSIS Office of Food Security and Emergency Preparedness, and other EOCs, as appropriate.
At the time of notification by USDA of the presumptive case of BSE, FDA’s OCM initiated its BSE Emergency Response Plan and activated FDA’s EOC. Various FDA headquarters and FDA center offices were immediately notified in accordance with the plan, as well as the FDA Seattle District Office (SEA-DO).
FDA responsibilities include conducting inspections and investigations to determine where any animal by-products went and ensuring that they did not enter commerce contrary to provisions of the FD&C Act and other statutes enforced by FDA.
On the same day FDA was notified of the presumptive case of BSE by USDA, FDA’s SEA-DO dispatched five investigative teams to investigate various facilities suspected of being either a source or recipient of affected material.
An aggressive schedule of inspections and investigations was pursued by FDA which enabled FDA to announce in December 27, 2003, that its investigators and inspectors from the states of Washington and Oregon had located the high risk material rendered from the one cow that had tested positive for BSE in Washington State and that the rendering plants that processed this material had placed a hold on the rendered material. The firms, located in Washington State and Oregon, assisted and cooperated fully with FDA’s investigation.
FDA advised the involved renderers on acceptable methods of disposing of material, such as landfill (coordinating with state and local officials and EPA), incineration, digestion, or conversion to a fuel/industrial source. Disposal of the meat and bone meal on hold has begun.
Communications, of course, have played a critical role in many aspects of the incident response. Late on December 23, 2003, FDA’s headquarters and district staff participated in a teleconference with APHIS and Washington State officials to ensure a coordinated response to the incident. FDA, CDC, Department of Defense, and FSIS continued to participate in APHIS-initiated interagency calls throughout the response to the incident.
FDA also has kept affected industries and State counterparts informed and up-to-date. On December 23, 2003, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) advised Washington State milk cooperatives that there was no known risk of BSE transmission from milk. The scientific data indicate that milk from BSE cows does not transmit BSE.
In responding to the BSE incident, FDA inspected and traced products at many different facilities, including renderers, feed mills, farms, dairy farms, calf feeder lots, slaughterhouses, meat processors, transfer stations, and shipping terminals. Notably, inspectors found no deviations from FDA’s feed rule.
Working with Foreign Governments
FDA officials regularly meet with representatives of foreign governments and international organizations on many levels and on many issues of common interest, including BSE. Immediately after the announcement on December 23, 2003, of a BSE-positive cow in the U.S., various foreign governments closed their markets to U.S. beef. Since that time, FDA officials, working closely with USDA officials, have been involved in numerous meetings and consultations with representatives of foreign governments to help address concerns and restore confidence in American products. For example:
FDA representatives met with Japanese officials from the Ministry of Agriculture, Forestry, and Fisheries, the Ministry of Health, Labor, and Welfare, the Food Safety Commission and the Japanese Embassy on January 9, 2004, to discuss BSE control measures in animal feed and food additives. FDA representatives met with numerous foreign attaches at USDA on January 12, 2004, to discuss FDA’s Center for Veterinary Medicine measures to prevent BSE in animal feeds. FDA representatives met in separate meetings on January 13, 2004, with officials from the CFIA and from Mexico’s Secretaría de Agricultura, Ganadería, Desarrollo Rural, Pesca y Alimentación to discuss current feed safety measures to prevent BSE in the U.S. The Ministers of Agriculture of the U.S., Mexico and Canada met on January 16, 2004, to coordinate ongoing interagency efforts towards expediting increased harmonization through a consultative process among the countries. I accompanied Secretary of Health and Human Services Tommy G. Thompson, at this meeting that resulted in a proposal to establish a Coordinating Committee on BSE to facilitate collaborative effort. Additionally, last week I visited with Japanese and Korean officials, as part of the U.S. Government’s delegation to discuss scientific and trade implications of the U.S. BSE case. The delegation also included senior scientific, regulatory, and trade officials from USDA, and the U.S. Trade Representative. Research
Several of FDA’s Centers, as well as many private laboratories, academic institutions, and other Federal Agencies (most notably NIH) are involved in significant research activities relating to TSEs. Basic areas requiring research include: increasing our understanding of prions; learning how prions are transmitted within a species and potentially between species; developing diagnostic tests for humans and animals; developing detection methods for use on regulated products; developing methods to increase or eliminate infectivity; and designing new treatments.
Most people envision research as being applied by medical practitioners to diagnose and treat disease. Applied research also is critical in a regulatory environment, where knowledge and tools gained through applied research can help us to achieve our mission more effectively and more efficiently.
Taking one example pertinent to BSE, current rendering processes do not completely inactivate the BSE agent. Advances in technology that could distinguish between BSE-infected and non-infected cattle, or that could completely inactivate the BSE agent in feed components may allow for exemptions to the feed regulations for those renderers and feed manufactures who apply these technologies.
Discussed below some examples of research on BSE and vCJD that could have significant regulatory implications and benefit:
FDA’s CFSAN is in the final year of funding a two-year project to develop sensors to detect abnormal prion protein in food. Work on the project should be completed in early 2004, and will result in a report on the usefulness of the sensors for detecting TSE agents in finished food products. No tests for the rapid diagnosis of vCJD have been validated as either sufficiently specific or sensitive to be used to screen the blood supply. A reliable blood-screening test for vCJD is an extremely important goal and is currently the object of considerable research activity. FDA has conducted and supported research efforts in the process of validating a rapid-DNA based method for detection of animal derived materials in animal feed and feed ingredients. As a part of this research effort, FDA has developed a Polymerase Chain Reaction probe to determine the animal species of origin from which feed ingredients were derived. FDA remains firmly committed to bringing better science to the public, to provide better public health protection at a lower cost. That’s why a key part of our BSE strategy involves fostering the development of better technologies to deal with BSE. To enhance the ability of our public health system to detect prohibited materials in animal feed, FDA will continue to support the development and testing of diagnostic tests to identify prohibited materials. As these tests are developed FDA will evaluate the utility of such tests promptly and thoroughly, so that there will be a quick and reliable method of testing animal feeds for prohibited materials.
Additional Measures to Bolster Protections Against BSE
FDA implemented the feed rule in 1997 based on the best information obtainable on the science and epidemiology of BSE at the time. The Agency also recognized that evolving, complex scientific and public health issues, particularly regarding BSE and vCJD, required the Agency to continue to assess and scrutinize the rule to ensure its integrity as a firewall against the potential for spread of BSE.
The Agency held a public hearing in October 2001 to solicit information and views on its present animal feed regulation. FDA requested information and views from individuals and organizations on the present rule and whether changes in the rule or other additional measures were necessary. The Agency was particularly interested in soliciting comments and views from individuals, industry, consumer groups, health professionals, and researchers with expertise in BSE and related animal and human diseases. The Agency specifically invited comments, both oral and written, on 17 questions about ways the rule and its enforcement might be improved to achieve its original objectives of preventing the establishment and amplification of BSE in the U.S. Transcripts of the hearing were then made publicly available with access through FDA’s website.
Soon after the public hearing, the USDA released the Harvard Center for Risk Analysis’s findings on the impact of various risks and potential pathways for exposure of U.S. cattle and U.S. citizens to the BSE agent. This assessment of the situation in the United States concluded that, due to control measures already in place, the risk to U.S. cattle and to U.S. consumers from BSE is very low. The model also demonstrated that certain new control measures could reduce the small risk even further.
To further explore ways the animal feed regulation could be improved in November 2002, FDA published an ANPR soliciting information and views from the affected industries and the public on some potential changes to its current feed regulation, including ways that the animal feed regulation could be strengthened. Information and comments were sought on the following five aspects of the BSE feed regulation: feasibility and impacts of excluding high risk materials, such as brain and spinal cord, from rendered animal products; use of poultry litter in cattle feed and impacts of banning such use; impacts of introducing new labeling requirements for pet food; methods to prevent cross-contamination between prohibited and non-prohibited material; use of plate waste in ruminant feed and impacts of eliminating such use.
Yesterday, we announced that we will be taking several additional steps to further strengthen the current robust safeguards that help protect Americans from exposure to the agent that causes BSE and help prevent the spread of BSE in U.S. cattle. These measures relate to both protections for foods intended for human consumption as well as additional measures to strengthen FDA’s 1997 final rule regulating animal feed. Many of these steps were raised in the November 2002, ANPR, as well as at the public meeting. With respect to human foods the Agency announced it will be extending to FDA-regulated foods, dietary supplements and cosmetics, restrictions on using specified risk materials that would complement the recent USDA announcements. Concerning animal feed, the Agency announced a series of measures designed to lower even further the risk that cattle will be purposefully or inadvertently fed “ruminant” proteins, including, eliminating the existing exemption in the feed rule that allows mammalian blood and blood products at slaughter to be fed to ruminants as a protein source; prohibiting the use of “poultry litter” as a feed ingredient for cattle and other ruminants; banning the use of “plate waste” as a feed ingredient for ruminants, including cattle; taking further steps to minimize the possibility of cross-contamination of animal feed via equipment, facilities or production lines; and evaluating additional mechanisms to enhance the ability of our public health system to detect prohibited materials in animal feed utilizing diagnostic tests.
In addition, FDA intends step up its inspections of feed mills and renderers in 2004. FDA is increasing its inspections of feed mills and renderers in 2004. Our 2001 base funding for BSE-related activities was $3.8 million. We shifted resources internally in 2001 and received a substantial increase from Congress in 2002. Our funded level for 2004 is currently approximately $21.5 million, almost a five-fold increase over the 2001 base. FDA will itself conduct 2,800 inspections and will make its resources go even further by working with state agencies to fund 3,100 contract inspections of feed mills and renderers and other firms that handle animal feed and feed ingredients. Through partnerships with states, FDA will also receive data on 700 additional inspections, for a total of 3,800 state contract and partnership inspections in 2004. These inspections would include 100 percent of all known renderers and feed mills that process products containing prohibited materials.
FDA has an enormous responsibility in assuring that the products the Agency regulates which contain bovine materials are safe and uncompromised by BSE or other TSEs. FDA’s principal line of defense in meeting this responsibility is to cut-off all avenues for the possible spread of BSE through U.S. cattle herds. Our most powerful tool in preventing the spread of BSE in U.S. cattle herds is effective enforcement of the Agency’s feed ban restrictions as part of a multi-layered set of firewalls put in place as part of the U.S. Government’s comprehensive BSE prevention program.
To date, a rigorous program of education, inspections, and enforcement education have enabled us to fulfill our responsibilities as part of the U.S. plan for preventing the spread of BSE. Although the risk of exposure to BSE in the United States remains extremely low and the measures in place are working, as a result of the recently discovered infected cow in the state of Washington, the Agency will be taking additional science-based steps to further strengthen our current protections.
FDA looks forward to continuing to assist Congress as it evaluates the risks associated with BSE, identifies opportunities to promote technologies that will detect and prevent the spread of BSE, and considers science-based approaches to further strengthen regulatory protections and bolster the resources available to assure that BSE does not present a threat to human or animal health in the U.S.
Thank you for the opportunity to testify today.
FDA to add new BSE-related feed rules soon Robert Roos News Editor
Sep 22, 2005 (CIDRAP News) – The head of the Food and Drug Administration (FDA) said this week the agency will soon align its rules on animal feed more closely with those in Canada and Europe, signaling a likelihood of new restrictions to prevent the spread of bovine spongiform encephalopathy (BSE), or mad cow disease.
The United States and Canada both ban the use of cattle parts in feed for cattle and other ruminant animals but allow cattle parts in feed for other animals such as pigs and poultry. However, Canada plans to ban the use of high-risk cattle parts, such as the brain and spinal cord of cattle older than 30 months, in all animal feeds in the near future. Europe already bans high-risk parts, called specified-risk materials (SRMs), from all animal feeds.
In July 2004 the FDA said it had reached a "preliminary" decision to ban SRMs from all animal feed, as recommended by an international panel of experts after the first US BSE case surfaced in December 2003. The agency promised to develop a proposal to that effect. SRMs are the tissues most likely to contain the abnormal proteins associated with BSE in infected animals.
FDA Commissioner Lester Crawford's comments in a Sep 19 speech now suggest the agency is about to go ahead with the plan, though he gave no date.
Crawford said the new rules will be "quite a bit stronger" than initially planned, according to a Sep 19 Bloomberg News report on his speech to the Consumer Federation of America. He said the rules will be similar to those in Europe and Canada.
"Our regulation will mimic theirs and it will supersede earlier considerations," Crawford was quoted as saying.
Will D. Hueston, DVM, a University of Minnesota professor who served on the expert panel that advised the US government about responses to the first BSE case, said Crawford's comments probably mean the FDA will ban SRMs from all animal feeds.
"I think it means they'll take additional action to remove SRMs from animal feeds—I think they' really targeting the high-risk materials, the brain and spinal cord," Hueston told CIDRAP News. "They're actively collaborating with Canada to try to get a uniform program, because we have a lot of trade with Canada in feed and animals and everything else."
"It's the international standard to remove SRMs from animal feed . . . in countries where BSE has been identified," said Hueston, who directs the university's Center for Animal Health and Food Safety.
SRMs are banned from human food; they are removed from cattle carcasses at slaughterhouses and taken to rendering plants, where they can currently be used in poultry feed and other nonruminant feeds. Hueston said the main concern is that cattle can be exposed to SRMs if they are accidentally given poultry feed. "So this [proposed ban] reduces the potential for leakage in the system."
Another pathway that exposes cattle to poultry feed is the practice of putting poultry litter—spilled bedding, feed, and waste collected underneath poultry cages—in cattle feed. Hueston said Canada has banned that, while the United States still permits it.
The FDA said last year it was considering banning the use of poultry litter in cattle feed. Reports on Crawford's speech didn't mention any comments on that issue.
"They [the FDA] haven't given a clear indication which way they're going to move on that," Hueston said. He commented that keeping SRMs out of poultry feed would address that concern.
According to accounts of his speech, Crawford did not suggest whether the FDA will ban the use of cattle blood and restaurant leftovers in cattle feed—practices that some regard as other risk factors for spreading BSE.
The United States has been trying to persuade Japan to reopen its market to US beef ever since BSE turned up here in 2003. According to the Bloomberg story, a draft report issued last week by Japan's Food Safety Commission said US cattle are more exposed to BSE than Japanese cattle because of insufficient feed regulations.
Hueston said the FDA is undoubtedly weighing the possible effects of its feed rules on the effort to reopen beef trade with Japan and other countries. "Aso, you don't want to create a brand-new disparity with Canada, when our beef industries are essentially joined at the hip," he added.
The Canadian Food Inspection Agency (CFIA) said this week it hopes to ban SRMs from all animal feeds by the end of this year, according to a Sep 20 Reuters report. The story quoted Billy Hewett, the CFIA's policy director, as saying, "I know it seems slow, but it is enormously complex."
PLEASE NOTE, WERE STILL WAITING $$$
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] RE-FOIA OF DECLARATION OF EXTRAORDINARY EMERGENCY BECAUSE OF AN ATYPICAL T.S.E. (PRION DISEASE) OF FOREIGN ORIGIN IN THE UNITED STATES [Docket No. 00-072-1]
With great disgust, I must report, that after years and years of wrangling over the infamous mad sheep of mad river valley, I have failed in getting an official answer via FOIA on the outcome of the TSE testing of those imported Belgium sheep. The USA Government refuses to tell the public, exactly what the testing outcome was, and in doing so, shows just how corrupt this administration has been. and the excuse given in their answer to my final appeal, which they have now officially denied, was bizarre to say the least ;
"I am denying your FOIA appeal. This is the final agency decision. You may seek judicial review of this decision in the United States district court for the judicial district in which you reside or have your principal place of business or in the District of Columbia, pursuant to 5 U.S.C. & 552(a)(4)(B)."
FOIA OF DECLARATION OF EXTRAORDINARY EMERGENCY BECAUSE OF AN ATYPICAL T.S.E. (PRION DISEASE) OF FOREIGN ORIGIN IN THE UNITED STATES [Docket No. 00-072-1]
WITH great sadness and disgust, the USDA OIG has finally shot me down for good, and have refused my FOIA request officially. I got the letter around Jan. 1, 2008 and have just not been able to admit defeat until now. The Faillace's claim their sheep were TSE free, and they very well may have been, I dont know, and we now find out we will never know. does not matter I suppose, the TSE they were worried about in those imported Belgium sheep was documented in 2007 in the USA in 5 different states i.e. the NOR-98. UNLESS, those sheep from Belgium imported to the USA had BSE, and that may be why they did not give the test results via the FOIA?
PLEASE NOTE, none of this answered my question and or FOIA request of what type TSE was finally diagnosed in those Vermont sheep, and or did they ever do mouse bio-assays, and if not, why not. none of these questions were ever answered, and probably never will be. also, the seven pages in question in hotline files. it was four pages of my old letter to them about BSE testing on top of the Sheep testing, two page letter from Ms MacNeil and one page of exemptions, and one page fax copy of my complaint sum on 'BSE Testing'. the one page of exemptions of the agencies reasons for not answering my question about those sheep and the mouse bio-assays, and the reason they law claim is because of individual privacy, adversely affect the individual, and or revealing their identify. which is nothing I was asking for. I was asking for the final results of the mouse-bioassays of the TSE in the Vermont sheep imported into the USA from Belgium. why is it they refuse to tell the public, what type Transmissible Spongiform Encephalopathy those sheep had ???
copy of letter as follows ;
UNITED STATES DEPARTMENT OF AGRICULTURE OFFICE OF INSPECTOR GENERAL WASHINGTON D.C. 20250
DEC 28, 2007
Mr. Terry S. Singeltary, Sr. P.O. Box 42 Bacliff, Texas 77518
Subject: FOIA Appeal-Log No. 08-00034 (No. 07-00060)
Dear Mr. Singeltary:
This is in response to your December 3, 2007, Freedom of Information Act (FOIA), 5 U.S.C. & 552, appeal of the November 20, 2007, decision of Ms. Deirdre MacNeil, FOIA/Privacy Act (PA) Attorney, Office of Inspector General (OIG), Department of Agriculture (USDA). As explained below, your FOIA appeal is denied.
As background, on March 1, 2007, you requested the "final results of the TSE Mouse-bioassays of those Atypical TSE in the Vermont Sheep." FOIA requires the release of agency records except where one or more of the nine enumerated exceptions apply. On November 20, 2007, Ms. MacNeil responded to your request by sending you seven pages from Hotline files PS-3340-0024, which was responsive to your request. Ms. MacNeil withheld identifying information pursuant to Exceptions 6 and 7(C) of the FOIA. See 5. U.S.C.& 552(b)(6) and (7)(C). On December 3, 2007, you appealed Ms. MacNeils decision.
To The Honorable Inspector General USDA,
see full history of this saga here ;
Tuesday, April 29, 2008 Interference at the EPA - Science and Politics at the U.S. Environmental Protection Agency ----- Original Message -----
From: "Terry S. Singeltary Sr." email@example.com To: "Bovine Spongiform Encephalopathy" BSE-L@aegee.org Cc: firstname.lastname@example.org; email@example.com; firstname.lastname@example.org; email@example.com; firstname.lastname@example.org; email@example.com; firstname.lastname@example.org; email@example.com; firstname.lastname@example.org
Sent: Monday, April 28, 2008 9:48 PM
Subject: Interference at the EPA Science and Politics at the U.S. Environmental Protection Agency
Reports and Research
Interference at the EPA
Science and Politics at the U.S. Environmental Protection Agency
The U.S. Environmental Protection Agency (EPA) has the simple yet profound charge "to protect human health and the environment." EPA scientists apply their expertise to protect the public from air and water pollution, clean up hazardous waste, and study emerging threats such as global warming. Because each year brings new and potentially toxic chemicals into our homes and workplaces, because air pollution still threatens our public health, and because environmental challenges are becoming more complex and global, a strong and capable EPA is more important than ever.
Yet challenges from industry lobbyists and some political leaders to the agency's decisions have too often led to the suppression and distortion of the scientific findings underlying those decisions—to the detriment of both science and the health of our nation. While every regulatory agency must balance scientific findings with other considerations, policy makers need access to the highest-quality scientific information to make fully informed decisions.
Concern over this problem led the Union of Concerned Scientists (UCS) to investigate political interference in science at the EPA. The investigation combines dozens of interviews with current and former EPA staff, analysis of government documents, more than 1,600 responses to a survey sent to current EPA scientists, and written comments from EPA scientists.
The results of these investigations show an agency under siege from political pressures. On numerous issues—ranging from mercury pollution to groundwater contamination to climate change—political appointees have edited scientific documents, manipulated scientific assessments, and generally sought to undermine the science behind dozens of EPA regulations. ...
snip...please see full text ;
''wasted days and wasted nights''
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518