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From: TSS ()
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 http://www.latimes.com/news/nationworld/nation/wire/sns-ap-fda-crawford,1,225845.story?coll=sns-ap-nation-headlines 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). snip... "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." snip... 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. #### http://www.fda.gov/bbs/topics/NEWS/2007/NEW01549.html 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, TSS Subject: BSE FDA MAD COW SAFEGUARDS LESTER CRAWFORD SOLD OUT TO THE HIGHEST BIDDER Former FDA Commissioner Pleads Guilty to Conflict of Interest and Making False Financial Disclosures 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. 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 like we have said time and time again, you cannot have the wolf guarding the henhouse. 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.) 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 http://www.fda.gov/OHRMS/DOCKETS/98fr/110602c.htm 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 (202) 720-9113 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; "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; 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 www.aphis.usda.gov and click on the "News" button. HHS news releases are available online at www.hhs.gov; FDA news releases can be found at www.fda.gov, which will also provide links to the documents discussed in this release. #### STATEMENT Introduction 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. Executive Summary 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. 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. Related Diseases 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. 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. 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. Import Controls 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. 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. 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. Conclusion 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. http://www.fda.gov/ola/2004/bse0127.html 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 $$$ some of those promises above have still yet to be implemented, AND, the USDA et al are still feeding cows to cows in 2006 ; Date: September 6, 2006 at 7:58 am PST PRODUCT RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II PRODUCT ______________________________ PRODUCT ______________________________ ______________________________ PRODUCT ______________________________ PRODUCT ______________________________ PRODUCT ______________________________ PRODUCT END OF ENFORCEMENT REPORT FOR AUGUST 9, 2006 ### ### ### ### PRODUCT END OF ENFORCEMENT REPORT FOR July 12, 2006 ### New Orleans District Telephone: 615-781-5380 WARNING LETTER NO. 2006-NOL-06 FEDERAL EXPRESS Mr. William Shirley, Jr., Owner Dear Mr. Shirley: On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration Our investigation found you failed to provide measures, including sufficient You failed to use clean-out procedures or other means adequate to prevent You failed to maintain written procedures specifying the clean-out As a result . the poultry meal you manufacture may contain protein derived This letter is not intended as an all-inclusive list of violations at your You should notify this office in writing within 15 working days of receiving Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S. Sincerely, /S Carol S. Sanchez Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog, 100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg Primate (oral route)* 1/2 (50%) Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%) RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%) PrPres biochemical detection The comparison is made on the basis of calibration of the bovine inoculum inoculated into mice and cattle.8 *Data are number of animals bioassays is generally judged to be about plus or minus 1 log. ic Table 1: Comparison of transmission rates in primates and cattle infected http://www.thelancet.com/journal/journal.isa also have shared Mr Bradley's surprise at the results because all the dose levels right down to 1 gram triggered infection. To cattle: 1 gram of infected brain material (by oral ingestion) [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirement for the Disposition of Non-Ambulatory Disabled Cattle 03-025IFA THE SEVEN SCIENTIST REPORT *** Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
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