Spread of BSE
Date: January 15, 2007 at 8:12 pm PST
REPORT OF THE COMMITTEE ON FEED SAFETY Chair: Kevin G. Custer, Des Moines, IA Vice Chair: Richard Sellers, Arlington, VA David C. Ailor, DC; Roy D. Brister, AR; Eric C. Gonder, NC; C. Ross Hamilton, TX; Jay Hawley, IN; Larry E. Hendricks, IL; Tom Holder, MD; Rex D. Holt, GA; David C. Kradel, PA; Elizabeth A. Lautner, IA; Gerald G. May, OH; David L. Meeker, VA; Gary D. Osweiler, IA; Jane F. Robens, MD; James E. Stocker, NC; H. Wesley Towers, DE; Elizabeth K. Wagstrom, IA; W. Douglas Waltman, GA; Gary L. Waters, MT. The Committee met at the Minneapolis Hilton Hotel, Minneapolis, Minnesota, Monday, October 16, 2006, 1:00-6:00 p.m., LaSalle Room. Twenty-three members and quest were present. Dr. Burt Pritchett, Center for Veterinary Medicine (CVM), Food and Drug Administration (FDA), gave an update on agency activities relative to bovine spongiform encephalopathy (BSE), the Animal Feed Safety System (AFSS) and contaminant limits. • BSE – The proposed rule (589.2001) to enhance the “feed rule” was published on October 6, 2005. CVM remains committed to publishing a final rule, but it is unlikely that publication will take place this year. FDA agrees that the economic impact was under estimated and is conducting a new economic evaluation. Carcass disposal is a major issue and revisions are needed relative to the environmental assessment. • AFSS – is a comprehensive, risk-based system for feed manufacture and distribution to minimize risks to animal and human health. It is intended to tie together regulation, policy and guidance. The goal is to complete the AFSS by the end of 2007. • Contaminant Limits – There is a lack of process for distinguishing feed hazards based upon their relative risks (Risk = Hazard x Exposure). The Feed Contaminants Program is scheduled for completion in 2010. Dr. Aaron Scott, Veterinary Services (VS), Animal and Plant Health Inspection Service (APHIS), United States Department of Agriculture (USDA) gave an update on BSE surveillance activities. To date, 189,000+ cases of BSE have been diagnosed. Of those, 89 percent occurred prior to 1997, and more than 96 percent have occurred in the United Kingdom (UK). USDA has conducted active surveillance since 1990. Surveillance is to monitor the presence of the disease in cattle, not to identify every case. The enhanced surveillance program began in June 2004 and ended in August 2006. More than 785,000 samples were analyzed. Two positive samples were identified. The conclusion of the enhanced surveillance program is that BSE prevalence is less than one infected animal per one million adult cattle. Dr. Scott emphasized the importance of clinical history accompanying samples, as those samples will carry more relative weight in the analysis of the data. Dr. Eric Nelson, President, American Association of Feed Control Officials (AAFCO), gave an update on association activities. AAFCO’s Model Feed Safety Program is designed to elevate the scope and effectiveness of current laws and regulations, and emerging systems and practices. The program will fill in the gaps of regulations and increase stakeholder participation. Richard Sellers, Vice President, American Feed Industry Association (AFIA), gave an update on the association’s Safe Feed/Safe Food program. The association is also monitoring European Union (EU) 183, which could put Hazard Analysis and Critical Control Point (HACCP) requirements on feed ingredients imported into the EU. Dr. David Meeker, Vice President, National Renderers Association (NRA), gave an update on the association’s Code of Practice Certification for rendering facilities, and rendered animal product blending facilities. Mr. Richard Sellers, AFIA introduced a new business item questioning the relevancy of the Committee on Feed Safety? Chair Custer responded that the relevance of a Committee is based upon issues addressed and resolutions generated. Only six of the twenty-two committee members attended the meeting. Discussions included the importance and need for a standing Committee on Feed Safety or could the Committee issues be distributed to another Committee. The Chair will be working with USAHA’s Executive Committee in reviewing how best to address the feed safety issues at USAHA.
SRM TASK FORCE
IMPORT AND EXPORT
----- Original Message ----- From: "Terry S. Singeltary Sr." To: Sent: Saturday, January 13, 2007 1:51 PM Subject: January 2007 Update on Feed Enforcement Activities to Limit the Spread of BSE
CVM Update January 12, 2007
January 2007 Update on Feed Enforcement Activities to Limit the Spread of BSE
To help prevent the establishment and amplification of BSE through feed in the United States, FDA implemented a final rule that prohibits the use of most mammalian protein in feeds for ruminant animals. This rule, Title 21 Part 589.2000 of the Code of Federal Regulations, called the Ruminant Feed Ban, became effective on August 4, 1997.
The following information is an update on FDA enforcement activities regarding the ruminant feed ban. FDA's Center for Veterinary Medicine (CVM) has assembled data from the inspections that have been conducted and whose final inspection report has been recorded in the FDA's inspection database as of January 6, 2007. As of January 6, 2007, FDA had received over 50,000 inspection reports. The majority of these inspections (around 68%) were conducted by State feed safety officials, with the remainder conducted by FDA officials.
Inspections conducted by FDA or State investigators are classified to reflect the compliance status at the time of the inspection based upon the objectionable conditions documented. These inspection conclusions are reported as Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI).
An OAI inspection classification occurs when significant objectionable conditions or practices were found and regulatory sanctions are warranted in order to address the establishment's lack of compliance with the regulation. An example of an OAI inspection classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspections classified with OAI violations will be promptly re-inspected following the regulatory sanctions to determine whether adequate corrective actions have been implemented.
A VAI inspection classification occurs when objectionable conditions or practices were found that do not meet the threshold of regulatory significance, but do warrant advisory actions to inform the establishment of findings that should be voluntarily corrected. Inspections classified with VAI violations are more technical violations of the Ruminant Feed Ban. These include provisions such as minor recordkeeping lapses and conditions involving non-ruminant feeds.
An NAI inspection classification occurs when no objectionable conditions or practices were found during the inspection or the significance of the documented objectionable conditions found does not justify further actions.
The results to date are reported here both by “segment of industry” and “in total”. NOTE – A single firm can operate as more than one firm type. As a result, the categories of the different industry segments are not mutually exclusive.
These firms are the first to handle and process (i.e., render) animal proteins and to send these processed materials to feed mills and/or protein blenders for use as a feed ingredient.
Number of active firms whose initial inspection has been reported to FDA – 271 Number of active firms handling materials prohibited from use in ruminant feed – 169 (62% of those active firms inspected) Of the 169 active firms handling prohibited materials, their most recent inspection revealed that: 1 firm (0.6%) was classified as OAI 2 firms (1.2%) were classified as VAI FEED MILLS NOT LICENSED BY FDA
These feed mills are not licensed by the FDA to produce medicated feeds.
Number of active firms whose initial inspection has been reported to FDA – 5,211 Number of active firms handling materials prohibited from use in ruminant feed – 2,360 (45% of those active firms inspected) Of the 2,360 active firms handling prohibited materials, their most recent inspection revealed that: 3 firms (0.1%) were classified as OAI 48 firms (2.0%) were classified as VAI PROTEIN BLENDERS
These firms blend rendered animal protein for the purpose of producing quality feed ingredients that will be used by feed mills.
Number of active firms whose initial inspection has been reported to FDA -- 362 Number of active firms handling materials prohibited from use in ruminant feed – 187 (52% of those active firms inspected) Of the 187 active firms handling prohibited materials, their most recent inspection revealed that: 2 firms (1.1%) were classified as OAI 2 firms (1.1%) were classified as VAI RENDERERS, FEED MILLS, AND PROTEIN BLENDERS MANUFACTURING WITH PROHIBITED MATERIAL
This category includes only those firms that actually use prohibited material to manufacture, process, or blend animal feed or feed ingredients.
Total number of active renderers, feed mills, and protein blenders whose initial inspection has been reported to FDA – 6,636 Number of active renderers, feed mills, and protein blenders processing with prohibited materials – 497 (7.5%) Of the 497 active renderers, feed mills, and protein blenders processing with prohibited materials, their most recent inspection revealed that: 6 firms (1.2%) were classified as OAI 16 firms (3.2%) were classified as VAI OTHER FIRMS INSPECTED
Examples of such firms include ruminant feeders, on-farm mixers, pet food manufacturers, animal feed salvagers, distributors, retailers, and animal feed transporters.
Number of active firms whose initial inspection has been reported to FDA – 16,653 Number of active firms handling materials prohibited from use in ruminant feed – 5,227 (31% of those active firms inspected) Of the 5,227 active firms handling prohibited materials, their most recent inspection revealed that: 4 firms (0.1%) were classified as OAI 178 firms (3.4%) were classified as VAI TOTAL FIRMS
Note that a single firm can be reported under more than one firm category; therefore, the summation of the individual OAI/VAI firm categories will be more than the actual total number of OAI/VAI firms, as presented below.
Number of active firms whose initial inspection has been reported to FDA – 19,492 Number of active firms handling materials prohibited from use in ruminant feed – 5,905 (30% of those active firms inspected) Of the 5,905 active firms handling prohibited materials, their most recent inspection revealed that: 7 firms (0.1%) were classified as OAI 188 firms (3.2%) were classified as VAI
Issued by: FDA, Center for Veterinary Medicine, Communications Staff, HFV-12 7519 Standish Place, Rockville, MD 20855 Telephone: (240) 276-9300 FAX: (240) 276-9115 Internet Web Site: http://www.fda.gov/cvm
[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
[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE)
THE SEVEN SCIENTIST REPORT ***
USA BSE OIG 2006
CDC DR. PAUL BROWN TSE EXPERT COMMENTS 2006
The U.S. Department of Agriculture was quick to assure the public earlier this week that the third case of mad cow disease did not pose a risk to them, but what federal officials have not acknowledged is that this latest case indicates the deadly disease has been circulating in U.S. herds for at least a decade.
The second case, which was detected last year in a Texas cow and which USDA officials were reluctant to verify, was approximately 12 years old.
These two cases (the latest was detected in an Alabama cow) present a picture of the disease having been here for 10 years or so, since it is thought that cows usually contract the disease from contaminated feed they consume as calves. The concern is that humans can contract a fatal, incurable, brain-wasting illness from consuming beef products contaminated with the mad cow pathogen.
"The fact the Texas cow showed up fairly clearly implied the existence of other undetected cases," Dr. Paul Brown, former medical director of the National Institutes of Health's Laboratory for Central Nervous System Studies and an expert on mad cow-like diseases, told United Press International. "The question was, 'How many?' and we still can't answer that."
Brown, who is preparing a scientific paper based on the latest two mad cow cases to estimate the maximum number of infected cows that occurred in the United States, said he has "absolutely no confidence in USDA tests before one year ago" because of the agency's reluctance to retest the Texas cow that initially tested positive.
USDA officials finally retested the cow and confirmed it was infected seven months later, but only at the insistence of the agency's inspector general.
"Everything they did on the Texas cow makes everything USDA did before 2005 suspect," Brown said. ...snip...end
CDC - Bovine Spongiform Encephalopathy and Variant Creutzfeldt ... Dr. Paul Brown is Senior Research Scientist in the Laboratory of Central Nervous System ... Address for correspondence: Paul Brown, Building 36, Room 4A-05, ...
PAUL BROWN M.D.
9 December 2005 Division of Dockets Management (RFA-305)
SEROLOGICALS CORPORATION James J. Kramer, Ph.D. Vice President, Corporate Operations
Embassy of Japan
Dockets Entered on December 22, 2005 2005D-0330, Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated ... EC 203, McDonald's Restaurants Corporation, Vol #:, 34 ... http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/122205/122205.htm
03-025IF 03-025IF-631 Linda A. Detwiler [PDF] Page 1. 03-025IF 03-025IF-631 Linda A. Detwiler Page 2. Page 3. Page 4. Page 5. Page 6. Page 7. Page 8. Page 9. Page 10. Page 11. Page 12. http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-631.pdf
03-025IF 03-025IF-634 Linda A. Detwiler [PDF] Page 1. 03-025IF 03-025IF-634 Linda A. Detwiler Page 2. Page 3. Page 4. Page 5. Page 6. Page 7. Page 8. http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-634.pdf
Page 1 of 17 9/13/2005 [PDF] ... 2005 6:17 PM To: email@example.com Subject: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food ... http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf
03-025IFA 03-025IFA-6 Jason Frost [PDF] ... Zealand Embassy COMMENTS ON FEDERAL REGISTER 9 CFR Parts 309 et al [Docket No. 03- 025IF] Prohibition of the Use of Specified Risk Materials for Human Food and ... http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-6.pdf
In its opinion of 7-8 December 2000 (EC 2000), the SSC ... [PDF] Page 1. Linda A. Detwiler, DVM 225 Hwy 35 Red Bank, New Jersey 07701 Phone: 732-741-2290 Cell: 732-580-9391 Fax: 732-741-7751 June 22, 2005 FSIS Docket Clerk US ...
Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission)
Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL IMPORTS FROM CANADA
Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION]
Docket Management Docket: 02N-0273 - Substances Prohibited From Use in
Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
Comment Number: EC -10
Accepted - Volume 2
18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7 December 2006 are now available.
4. Members had received information about the notification by the Health Protection Agency (HPA) of recipients of four batches of plasma products that had been produced from blood donated by individuals that had later developed variant Creutzfeldt Jakob Disease (vCJD). THESE batches HAD NOT been included in a similar notification exercise in 2004, as the fate of these products COULD NOT BE TRACED at that time. The fourteenth annual report of the National CJD Surveillance Unit had been published. The European Food Safety Authority (EFSA) had issued a consultation on a revised methodology for geographical bovine spongiform encephalopathy (BSE) risk assessment. Members could submit individual responses. Submission of a SEAC response was under consideration.
ITEM 9 - ANY OTHER BUSINESS
64. A member noted that at the recent Neuroprion meeting, a study was presented showing that in transgenic mice BSE passaged in sheep may be more virulent and infectious to a wider range of species than bovine derived BSE. Other work presented suggested that BSE and bovine amyloidotic spongiform encephalopathy (BASE) MAY BE RELATED. A mutation had been identified in the prion protein gene in an AMERICAN BASE CASE THAT WAS SIMILAR IN NATURE TO A MUTATION FOUND IN CASES OF SPORADIC CJD. A study also demonstrated that in a mouse model it was possible to alleviate the pathological changes of prion disease by suppressing expression of the prion protein gene after infection.
Terry S. Singeltary SR. P.O. Box 42 Bacliff, Texas USA 77518