Oldtimer said:
Close the feedban loopholes-- enact M-COOL so the consumers can make an informed choice- then open up the Border.....
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FDA still pondering…and pondering expanded BSE feed ban
FDA still floundering with first mad cow feed ban of 8-4-97 and other broken promises :???:
Canada widens BSE-related feed ban; US still pondering
Robert Roos News Editor
Jul 13, 2007 (CIDRAP News) – Canada broadened its safeguards against bovine spongiform encephalopathy (BSE), or mad cow disease, yesterday by banning the use of cattle brains, spinal cords, and certain other body parts from all animal feeds, pet foods, and fertilizer.
The step will speed up the elimination of BSE from Canadian cattle, government officials said, but for now it is creating a major waste-disposal challenge and bureaucratic headaches, according to Canadian news reports.
The Canadian rule applies to "specified risk materials" (SRM), meaning cattle parts that are likely to contain the BSE agent if the animal is infected. They include the skull, brain, eyes, tonsils, spinal cord, and certain nerve bundles (trigeminal and dorsal root ganglia) in cattle 30 months or older, plus the distal ileum (part of the small intestine) of all cattle.
The collective weight of all those materials is estimated at more than 100,000 tons per year in Canada, according to Freeman Libby, director of the Canadian Food Inspection Agency's (CFIA's) Feed Ban Task Force, who was quoted in a Jul 9 CanWest News Service report. All of that must now be disposed of differently than in the past.
US eyes narrower restrictions
The United States, meanwhile, is considering copying the Canadian action in part, but it's not clear how soon that might happen. In October 2005, the Food and Drug Administration proposed banning the brains and spinal cords of older cattle from animal feed and pet food, and the agency has been reviewing comments on the proposal for more than a year.
"There is no estimated time frame on when a final rule will be published," FDA spokesman Michael Herndon told CIDRAP News yesterday. "The agency is working to develop and issue a final rule as expeditiously as possible." He said he couldn't give any explanation for the delay.
Because cattle contract BSE by eating infective material from other cattle, both the United States and Canada banned the use of cattle protein in feed for cattle and other ruminant animals in 1997. But the two countries have continued to allow cattle parts in feed for nonruminant animals, such as pigs and poultry.
After Canada discovered its first BSE case in May 2003, the country banned the use of SRM from cattle older than 30 months in human food. The United States followed suit shortly after the first US case of BSE was found in December 2003. Canada has discovered a total of 10 BSE cases, the last one in May, while the United States has found three, the last one in March 2006.
The reason for banning SRM from animal feed and pet food is to prevent the possible spread of BSE through accidental mixing of ruminant and nonruminant feed during feed manufacturing or through misfeeding of nonruminant feed to ruminants.
Canada announced plans for the extended feed ban in June 2006. In marking the advent of the new rules yesterday, Canadian Agriculture and Agri-Food Minister Chuck Strahl said the government "has taken a significant step toward accelerating the elimination of bovine spongiform encephalopathy (BSE) from Canadian cattle. These new rules will help increase access to foreign markets, and support Canada's status as a controlled risk country for BSE from the World Organization for Animal Health (OIE)."
A CFIA fact sheet says that with the broader feed ban, BSE is expected to be eliminated from Canadian cattle in about 10 years; without the new rules, eradication was expected to take several decades.
Effects of the ban
The ban means producers can no longer feed any products containing SRM to livestock, and slaughterhouses must identify SRM so they can be removed from the feed system, the CFIA said. In addition, those who handle, transport, or dispose of cattle carcasses and certain cattle tissues must have a CFIA permit.
"This system enables continuous control over SRM, so that it does not enter the animal feed system," the agency said.
To help industry set up the infrastructure for SRM disposal, the Canadian government is providing $80 million for provincial disposal programs, the CFIA said. Most provinces have established such programs, for which they must provide 40% of the funding, with the federal government supplying the rest, according to the release.
The new restrictions are causing major headaches for the cattle industry, according to the CanWest News report.
The story said SRM must now be removed with special equipment, hauled away in dedicated trucks, processed, and then buried in landfills, burned in high-temperature incinerators, or dumped into composters and bioenergy plants.
The $80 million the federal government is investing "has yet to reach many people on the front lines whose bills are soaring as they scramble to meet the new rules," the story said. Dennis Laycraft, executive vice president of the Canadian Cattlemen's Association, called the situation "enormously frustrating."
For example, Johnston Packers, a slaughterhouse near Chilliwack, B.C., planned to spend $1 million on new equipment and space for removal and handling of SRM, according to the report. But the project was stalled by delays in government funding, and the company had to come up with a temporary solution so the plant could continue to operate.
USDA makes BSE-related rules permanent
Meanwhile, the US Department of Agriculture (USDA) announced yesterday that several BSE-related interim rules, including the ban on SRM from human food, have been made permanent. The agency didn't say whether it intentionally timed the announcement to coincide with the broadening of Canada's feed ban.
The USDA announced the ban on SRM in the food supply as an interim rule in January 2004, about 3 weeks after the first US BSE case was found. At the same time, the agency posted interim rules banning (1) the use of "downer" cattle—those that can't walk when presented for slaughter—for food and (2) the use of high-pressure cattle-stunning devices that could drive SRM tissue into meat.
Yesterday the USDA's Food Safety and Inspection Service said these rules have been made permanent. "Experience has borne out that these interim steps were correct and should be made permanent," said Dr. Richard Raymond, USDA under secretary for food safety, in a news release.
See also:
CFIA information page on enhanced feed ban
http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/enhren/enhrene.shtml
Jun 27, 2006, CIDRAP News story "Canada to expands feed ban to prevent BSE"
Oct 4, 2005, CIDRAP News story "FDA to ban some cattle parts from animal feed"
Jul 12 USDA news release on final rule banning use of downer cattle for food
http://www.fsis.usda.gov/News_&_Events/NR_071207_01/index.asp
Text of USDA final rule on downer cattle and SRM in human food
http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/03-025F.pdf
http://www.cidrap.umn.edu/cidrap/content/other/bse/news/jul1307feedban.html
USA MAD COW REGULATION BROKEN PROMISES
913. SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
Agency:
Department of Health and Human Services (HHS)/Food and Drug Administration (FDA)
Priority:
Other Significant
Legal Authority:
21 USC 321; 21 USC 342; 21 USC 343; 21 USC 349; 21 USC 371
CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)
21 CFR 589.2001
Legal Deadline:
None
Abstract:
On October 6, 2005, the Food and Drug Administration (FDA) proposed to amend its regulations to prohibit the use of certain cattle origin materials in the food or feed of all animals to help strengthen existing safeguards to prevent the spread of bovine spongiform encephalopathy (BSE) in U.S. cattle. The discovery of a BSE-positive dairy cow in December 2003 has caused FDA to review its policies for prevention of BSE which resulted in this rulemaking.
Timetable: Action Date FR Cite
ANPRM 07/14/04 69 FR 42288
ANPRM Comment Period End 08/13/04
NPRM 10/06/05 70 FR 58569
NPRM Comment Period End 12/20/05
Final Action 07/00/06
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Burt Pritchett, Biologist, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, HFV-222, 7519 Standish Place, MPN-4, Rockville, MD 20855
Phone: 240 453-6860
Fax: 240 453-6882
Email:
[email protected]
RIN:
0910-AF46
http://ciir.cs.umass.edu/cgi-bin/ua/web_fetch_doc?dataset=ua&db=agendaSpring2006&query=and&doc_id=913
914. USE OF MATERIALS DERIVED FROM CATTLE IN HUMAN FOOD AND COSMETICS
Agency:
Department of Health and Human Services (HHS)/Food and Drug Administration (FDA)
Priority:
Other Significant
Legal Authority:
21 USC 342; 21 USC 361; 21 USC 371
CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)
21 CFR 189.5; 21 CFR 700.27
Legal Deadline:
None
Abstract:
On July 14, 2004, FDA issued an interim final rule (IFR), effective immediately, to prohibit the use of certain cattle material, to address the potential risk of bovine spongiform encephalopathy (BSE), in human food, including dietary supplements, and cosmetics. Prohibited cattle materials under the IFR include specified risk materials, small intestine of all cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, and mechanically separated (MS) (Beef). Specified risk materials are the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older; and the tonsils and distal ileum of the small intestine of all cattle. Prohibited cattle materials do not include tallow that contains no more than 0.15 percent hexane-insoluble impurities and tallow derivatives. This action minimizes human exposure to materials that scientific studies have demonstrated are highly likely to contain the BSE agent in cattle infected with the disease. Scientists believe that the human disease variant Creutzfeldt-Jakob disease (vCJD) is likely caused by the consumption of products contaminated with the agent that causes BSE. After reviewing comments received to the interim final rule, FDA intends to issue a final rule.
On September 7, 2005, FDA amended the IFR to permit the use of small intestine in human food and cosmetics if it is effectively removed from the distal ileum. The amendment also clarified that milk and milk products, hides, and tallow derivatives are not prohibited for use in human food and cosmetics.
Timetable: Action Date FR Cite
Interim Final Rule 07/14/04 69 FR 42256
Interim Final Rule Comment Period End 10/12/04
Interim Final Rule (Ammendments) 09/07/05 70 FR 53063
Final Action 07/00/06
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Morris E. Potter, Lead Scientist for Epidemiology, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, HFS-032, 60 Eighth St., NE, Atlanta, GA 30309
Phone: 404 253-1225
Fax: 404-253-1218
Email:
[email protected]
RIN:
0910-AF47
http://ciir.cs.umass.edu/cgi-bin/ua/web_fetch_doc?dataset=ua&db=agendaSpring2006&query=and&doc_id=914
915. RECORDKEEPING REQUIREMENTS FOR HUMAN FOOD AND COSMETICS MANUFACTURED FROM, PROCESSED WITH, OR OTHERWISE CONTAINING MATERIAL FROM CATTLE
Agency:
Department of Health and Human Services (HHS)/Food and Drug Administration (FDA)
Priority:
Other Significant
Legal Authority:
21 USC 342; 21 USC 361; 21 USC 371; 21 USC 381
CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)
21 CFR 189.5; 21 CFR 700.27
Legal Deadline:
None
Abstract:
On July 14, 2004, FDA proposed to require that manufacturers and processors of human food and cosmetics that are manufactured from, processed with, or otherwise contain, material from cattle must establish and maintain records sufficient to demonstrate the food or cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle materials. This is a companion rulemaking to FDA's interim final rule entitled "Use of Materials Derived From Cattle in Human Food and Cosmetics." FDA intends to finalize this proposal after reviewing any comments received.
Timetable: Action Date FR Cite
NPRM 07/14/04 69 FR 42275
NPRM Comment Period End 08/13/04
Final Action 09/00/06
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Rebecca Buckner, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, HFS-366, College Park, MD 20740
Phone: 301 436-1486
Fax: 301 436-2632
Email:
[email protected]
RIN:
0910-AF48
http://ciir.cs.umass.edu/cgi-bin/ua/web_fetch_doc?dataset=ua&db=agendaSpring2006&query=and&doc_id=915
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 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.
###
http://www.fda.gov/bbs/topics/news/2004/hhs_012604.html
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 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.
####
http://www.fda.gov/bbs/topics/news/2004/NEW01084.html
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
http://www.fda.gov/ola/2004/bse0127.html
DARLING INT. INC. $$$
http://www.fda.gov/ohrms/dockets/dailys/04/aug04/081704/04n-0264-c00107-vol20.pdf
NATIONAL BY-PRODUCTS, LLC $$$
http://www.fda.gov/OHRMS/DOCKETS/dailys/04/aug04/081104/04n-0264-emc00534.txt
GRIFFIN INDUSRIES INC. $$$
http://www.fsis.usda.gov/OPPDE/Comments/04-021ANPR/04-021ANPR-65.pdf
FDA Week
August 12, 2005
SECTION: Vol. 11 No. 32
LENGTH: 368 words
HEADLINE: FDA BACKS OFF PROMISE TO BAN BLOOD, POULTRY LITTER FROM ANIMAL FEED
BODY:
FDA is backing off its previous promise to ban animal blood, poultry litter and plate waste from animal feed to protect against the spread of mad cow disease.
FDA Commissioner Lester Crawford unveiled the change Monday (Aug. at the 51st International Congress on Meat Science and Technology.
"Earlier last year we had announced other potential changes being considered, including the prohibition of mammalian blood and blood products in ruminant feed, the prohibition of poultry litter, and the prohibition of plate waste," according to the printed version of Crawford's speech. "But we are now focusing our efforts on specified risk materials."
House Democrats asked Crawford about the feed ban at an Appropriations Committee late last month, but Crawford danced around the questions. He told lawmakers FDA was going to issue an interim final rule on the feed ban, but at the meat industry conference he said the agency is issuing a proposed rule. Another FDA official also said the agency is issuing a proposed rule, not an interim final rule.
Crawford told the meat conference attendees that the feed ban proposed rule could call for prohibiting brains and spinal cords from cattle older than 29 months.
On Jan. 26, 2004, then-HHS Secretary Tommy Thompson said FDA was going to ban the practice of feeding cattle animal blood, poultry litter and plate waste. FDA issued a press release the same day providing details about the interim final rules.
FDA was following the lead of the U.S. Agriculture Department, which had announced weeks earlier that it was tightening regulations to prevent the spread of bovine spongiform encephalopathy (BSE), or mad cow disease.
However, a Public Citizen source says the Office of Management and Budget (OMB) kept FDA from banning blood from animal feed by refusing to give FDA the emergency designation needed to quickly put the rules into effect (see FDA Week, July 13). Although the USDA implemented its new regulations within weeks, FDA waited months before finally issuing an "advanced notice of proposed rule making" that requested suggestions on how, or if, it should change the feed ban.
The proposed rule FDA is expected to issue also will have to pass through OMB.
LOAD-DATE: August 12, 2005
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
http://www.pharmalive.com/News/index.cfm?articleid=382127&categoryid=30
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WAY back in time ;
U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
November 14, 2000
Letter to Reiterate Certain Public Health and Safety Concerns to Firms
Manufacturing or Importing Dietary Supplements that Contain Specific Bovine
Tissues
To: Manufacturers and Importers of Dietary Supplements and Dietary
Supplement Ingredients:
The Food and Drug Administration (FDA) is taking this opportunity to
reiterate certain public health and safety concerns to firms manufacturing
or importing dietary supplements that contain specific bovine tissues. The
safety concerns about bovine-derived dietary supplement ingredients,
including extracts or substances derived from such tissues, are a result of
the fact that bovine-derived ingredients from cattle born, raised, or
slaughtered in certain countries present a risk of transmitting the
infectious agent that causes bovine spongiform encephalopathy (BSE) to
humans consuming such products. FDA strongly recommends that firms should
consider the public health consequences of this disease in taking whatever
steps are necessary to assure themselves and the public that such
ingredients do not come from cattle born, raised, or slaughtered in
countries where BSE exists.
Background
BSE is a transmissible neurologic disorder of cattle and is prevalent in
certain parts of the world. This neurological disease is one of a number of
transmissible spongiform encephalopathies (TSE) known and is similar to
other TSEs such as scrapie in sheep and Creutzfeldt-Jakob disease (CJD) in
humans. It is believed that the spread of BSE in cattle in some countries,
particularly Great Britain, was caused by the feeding of infected cattle and
sheep tissues to cattle. While transmission of the causative agent of BSE to
humans has not been definitively documented to date, inter-species transfer
has been demonstrated (e.g., mice can be infected by exposure to infected
bovine tissues). BSE has never been diagnosed in cattle in the United
States. However, although steps have been taken to control the spread of BSE
in cattle, new cases of BSE continue to be identified in certain European
countries. This fact illustrates that serious public health risks associated
with the consumption of animal-derived ingredients from animals sourced from
BSE-positive countries remain because such tissues may contain the causative
agent of BSE.
Recommendations
Although there is still no definitive evidence that the consumption of
bovine tissues that contain the transmissible agent for BSE cause CJD in
humans, FDA is concerned that appropriate measures to eliminate the use of
bovine tissues from BSE-countries be instituted by firms that use
bovine-derived ingredients in their products. The list of countries where
BSE is known to exist is maintained by the U.S. Department of Agriculture
(USDA) and codified in Title 9, Code of Federal Regulations, Part 94.18.
Currently, the list of countries in which BSE is know to exist includes
Great Britain, France, The Netherlands, Portugal, Luxembourg, Ireland,
Switzerland, Oman, and Belgium.
We strongly recommend that firms manufacturing or importing dietary
supplements which contain specific bovine tissues (see enclosure), including
extracts or substances derived from such tissues, take all steps necessary
to assure themselves and the public that such ingredients do not come from
cattle born, raised, or slaughtered in countries where BSE exists. FDA
believes that any firm using BSE-derived ingredients should take immediate
and continued actions to minimize the potential risk of human exposure to
the infectious agent that causes BSE in cattle.
We appreciate your attention to and cooperation in this matter. If you need
more information or have questions, please contact the Director, Division of
Compliance and Enforcement (HFS-810), Office of Nutritional Products,
Labeling, and Dietary Supplements, 200 C St., SW, Washington, DC 20204
(telephone 202-205-5229) or your local FDA District Office.
Sincerely,
Christine J. Lewis, Ph.D.
Director
Office of Nutritional Products, Labeling, and Dietary Supplements
Center for Food Safety and Applied Nutrition
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Enclosure
List of Tissues with Suspected Infectivity(1)
Category I (High infectivity)
brain
spinal cord
Category II (Medium infectivity)
ileum
lymph nodes
proximal colon
spleen
tonsil
dura mater
pineal gland
placenta
cerebrospinal fluid
pituitary gland
adrenal gland
Category III (Low infectivity)
distal colon
nasal mucosa
sciatic nerve
bone marrow
liver
lung
pancreas
thymus gland
List taken from Report of a WHO Consultation on Public Health Issues Related
to Animal and Human Spongiform Encephalopathies, World Health Organization,
Office of Interantional Epizootics, Geneva, Switzerland, November 12-14,
1991.
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The absence of a specific tissue, organ, or gland from this list does not
mean that such tissue, organ, or gland cannot contain the infectious agent
responsible for BSE. It only means that there was not adequate information
available at the time to assign the tissue, organ, or gland to a specific
category.
http://www.cfsan.fda.gov/~dms/dspltr05.html
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full text ;
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0702&L=sanet-mg&P=4964
still floundering. ... bacliff, texas. ..........tss