Subject: Re: Docket No. 2005N-0373 RIN number 0910-AF54 Use of Materials Derived From Cattle in Medical Products REOPENING COMMENT PERIOD Date: March 30, 2007 at 11:37 am PST
Subject: Re: Docket No. 2005N-0373 RIN number 0910-AF54 TSS SUBMISSION Date: March 30, 2007 at 10:57 am PST
[Federal Register: March 30, 2007 (Volume 72, Number 61)] [Proposed Rules] [Page 15080-15081] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr30mr07-24]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 211, 226, 300, 500, 530, 600, 895, and 1271 [Docket No. 2005N-0373] RIN 0910-AF54
Use of Materials Derived From Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants;
Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; reopening of the comment period.
SUMMARY: The Food and Drug Administration (FDA) is reopening until May 14, 2007, the comment period for the proposed rule published in the Federal Register of January 12, 2007 (72 FR 1582). The proposed rule would prohibit the use of certain cattle material in, or in the manufacture (including processing) of, drugs, biologics, and medical devices intended for use in humans and human cells, tissues, and cellular and tissue-based products (HCT/Ps) (collectively, medical products for humans), and in drugs intended for use in ruminant animals (drugs for ruminants) and would also require new recordkeeping provisions for medical products for humans and drugs for ruminants that are manufactured from or otherwise contain material from cattle. The agency is reopening the comment period in response to a request for more time to enable industry to generate more information on products that might be affected by the rule. DATES: Submit written or electronic comments on the proposed rule by May 14, 2007. ADDRESSES: You may submit comments, identified by Docket No. 2005N-0373 and RIN number 0910-AF54, by any of the following methods: Electronic Submissions Submit electronic comments in the following ways: Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Agency Web site: http://www.fda.gov/dockets/ecomments. Follow the instructions for submitting comments on the agency Web site. Written Submissions Submit written submissions in the following ways: FAX: 301-827-6870. Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal or the agency Web site, as described previously in the ADDRESSES portion of this document under Electronic Submissions. Instructions: All submissions received must include the agency name and Docket No(s). and Regulatory Information Number (RIN) for this rulemaking. All comments received may be posted without change to http://www.fda.gov/ohrms/dockets/default.htm, including any personal information provided. For additional information on submitting comments, see section II ``Comments'' in the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or comments received, go to http://www.fda.gov/ohrms/dockets/default.htm and insert the docket number(s), found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: For information concerning products regulated by the Center for Drug Evaluation and Research: Audrey A. Thomas, Center for Drug Evaluation and Research (HFD-007), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5533, e-mail: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000035/!x-usc:mailto:firstname.lastname@example.org. For information concerning products regulated by the Center for Biologics Evaluation and Research: Stephen M. Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852- 1448, 301-827-6210, e-mail: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000035/!x-usc:mailto:email@example.com. For information concerning products regulated by the Center for Devices and Radiological Health: Scott G. McNamee, Center for Devices and Radiological Health, Food and Drug Administration, 2094 Gaither Rd., rm. 230, Rockville, MD 20850, 240-276-0105, e-mail: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000035/!x-usc:mailto:firstname.lastname@example.org. For informat on concerning products regulated by the Center for Veterinary Medicine: Michael J. Popek, Center for Veterinary Medicine (HFV-144), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6462, e-mail: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000035/!x-usc:mailto:email@example.com. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of January 12, 2007 (72 FR 1582), FDA published a proposed rule that, if finalized, would prohibit the use of certain cattle material in, or in the manufacture (including processing) of, medical products for humans and drugs for ruminants. FDA also proposed new recordkeeping requirements for medical products for humans and drugs for ruminants that are manufactured from or otherwise contain material from cattle. Interested persons were given until March 13, 2007, to submit written or electronic comments to the agency on the proposal. On February 12, 2007, [[Page 15081]] FDA received a request to extend the comment period. FDA believes that extending the comment period by 45 days is appropriate to allow industry to generate information on products that might be affected by the rule. Therefore, FDA is extending the comment period until May 14, 2007. This extension will provide the public with a total of 105 days to submit comments. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the proposed rule. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the Docket No. 2005N-0373. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: March 23, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-5894 Filed 3-29-07; 8:45 am] BILLING CODE 4160-01-S
----- Original Message -----
From: Terry S. Singeltary Sr.
Cc: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000035/!x-usc:mailto:firstname.lastname@example.org ; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000035/!x-usc:mailto:email@example.com ; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000035/!x-usc:mailto:firstname.lastname@example.org
Sent: Wednesday, January 24, 2007 5:40 PM
Subject: Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants; Proposed Rule Docket No. 2005N-0373 RIN # 0910-AF54
A kind greetings from Texas. I tried submitting this twice, and was not sure either time if it was recieved and downloaded correctly. so i send this to you in case it did not...........many thanks, terry
Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants; Proposed Rule Docket No. 2005N-0373 RIN # 0910-AF54
COMMENT SUBMISSION TO ;
Docket No. 2005N-0373 and RIN number 0910-AF54
[Federal Register: January 12, 2007 (Volume 72, Number 8)] [Proposed Rules] [Page 1581-1619]
Docket No. 2005N-0373 and RIN number 0910-AF54
Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants; Proposed Rule
SUMMARY: The Food and Drug Administration (FDA) is proposing to prohibit the use of certain cattle material in, or in the manufacture (including processing) of, drugs, biologics, and medical devices intended for use in humans and human cells, tissues, and cellular and tissue-based products (HCT/Ps) (collectively, medical products for humans), and in drugs intended for use in ruminant animals (drugs for ruminants). FDA is also proposing new recordkeeping requirements for medical products for humans and drugs for ruminants that are manufactured from or otherwise contain material from cattle. FDA is proposing these actions as part of its continuing efforts to strengthen defenses against the potential risk of exposure to, and spread of, bovine spongiform encephalopathy (BSE) and related human disease in the United States.
DATES: Submit written or electronic comments on the proposed rule by March 13, 2007. Submit written comments on the information collection requirements by February 12, 2007. Requests for an informal hearing on the proposed ban related to medical devices must be submitted by February 12, 2007.
ADDRESSES: You may submit comments, identified by Docket No. 2005N-0373 and RIN number 0910-AF54, by any of the following methods: Electronic Submissions Submit electronic comments in the following ways: Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Agency Web site:
TSS SUBMISSION TO ;
Docket No. 2005N-0373 and RIN number 0910-AF54
Greetings FDA et al, ONCE again I would kindly like to comment on the continuous failed attempts by the FDA to regulate the use of certain cattle material in, or in the manufacture including processing) of, drugs, biologics, and medical devices intended for use in humans and human cells, tissues, and cellular and tissue-based products (HCT/Ps) (collectively, medical products for humans), and in drugs intended for use in ruminant animals (drugs for ruminants) from the proven risk factors of Transmissible Spongiform Encephalopahy i.e. TSE's in all species. I have continued to warn the FDA et al about these risk factors via the surgical and medical arena (vaccines, nutritional supplements, bovine heart valves, and other animal donor tissue), and I have continued to point out the risk factor of the UKBSENVCJD only theory, and the ramifications there from, i.e. BASE (bovine amyloidotic spongiform encephalopathy), and my greatest fears, one I have warned you about time and time again, seems to be coming true ;
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.
3:00 Afternoon Refreshment Break, Poster and Exhibit Viewing in the Exhibit Hall
3:30 Transmission of the Italian Atypical BSE (BASE) in Humanized Mouse
Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western Reserve University
Bovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE strain discovered recently in Italy, and similar or different atypical BSE cases were also reported in other countries. The infectivity and phenotypes of these atypical BSE strains in humans are unknown. In collaboration with Pierluigi Gambetti, as well as Maria Caramelli and her co-workers, we have inoculated transgenic mice expressing human prion protein with brain homogenates from BASE or BSE infected cattle. Our data shows that about half of the BASE-inoculated mice became infected with an average incubation time of about 19 months; in contrast, none of the BSE-inoculated mice appear to be infected after more than 2 years. ***These results indicate that BASE is transmissible to humans and suggest that BASE is more virulent than classical BSE in humans.
6:30 Close of Day One
Volume 12, Number 12-December 2006
On the Question of Sporadic or Atypical Bovine Spongiform Encephalopathy and
SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM 1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype of 'UNKNOWN' strain growing. ...
There is a growing number of human CJD cases, and they were presented last week in San Francisco by Luigi Gambatti(?) from his CJD surveillance collection.
He estimates that it may be up to 14 or 15 persons which display selectively SPRPSC and practically no detected RPRPSC proteins.
Disturbingly, we now know that the USA has had, beyond any shadow of a doubt, been circulating TSE in a very wide variety of products, and have been for decades. Even more disturbingly, we now have to deal with, whether or not the industry like it or not, atypical TSE i.e. BASE in the USA. NOW we have the 4th documented vCJD transfusion related case in the U.K., this raises serious questions about blood and tissue related products in relations to TSE transmission from all species ;
Date: January 18, 2007 at 8:32 am PST
Fourth case of transfusion-associated vCJD infection in the United Kingdom
Editorial team (mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000035/!x-usc:mailto:email@example.com), Eurosurveillance editorial office
A suspected case of variant Creutzfeldt-Jakob disease (vCJD) has recently been diagnosed in a patient in the United Kingdom (UK), who received a blood transfusion from a donor who later developed vCJD . This is the fourth case of probable transfusion transmission of vCJD infection in the UK. Three of the four recipients developed symptoms of vCJD. The first symptomatic case of vCJD associated with blood transfusion was identified in December 2003. This individual developed vCJD six and a half years after transfusion of red cells donated by an individual who developed symptoms of vCJD three and a half years after donation.
A second case of vCJD 'infection' was identified a few months later in a person who had received red cells from a donor who developed symptoms of vCJD 18 months after donation. This patient (the second case) died from causes unrelated to vCJD five years after transfusion. Post-mortem investigations found abnormal prion protein in the spleen and a cervical lymph node., However, prion protein was not found in the brain, and no pathological features of vCJD were found.
A third case developed symptoms of vCJD six years after receiving a transfusion of red blood cells, and died two years and eight months later. The donor of the blood involved developed vCJD about 20 months after donating it.
These three cases have been published as case reports and in the findings of the ongoing collaborative study between the National Blood Services, the National CJD Surveillance Unit, and the Office for National Statistics. This study aims to collect evidence about transmission of CJD or vCJD via the blood supply [2,3,4,5].
The new, fourth case is in a patient who developed symptoms of vCJD eight and a half years after receiving a transfusion of red blood cells from a donor who developed vCJD about 17 months after this blood was donated . The donor to this case also donated the vCJD-implicated blood transfused to the third case. As for all other reported clinical vCJD cases that have been tested for genotype, this patient is a methionine homozygote at codon 129 of the prion protein gene. The patient is currently alive.
All four cases had received transfusions of non-leucodepleted red blood cells between 1996 and 1999. Since October 1999, leucocytes have been removed from all blood used for transfusion in the UK. The effect of leucodepletion on the reduction of the risk of transmission of vCJD from an infective donation is uncertain.
This fourth case of vCJD infection associated with blood transfusion further increases the level of concern about the risk of vCJD transmission between humans by blood transfusion, although much remains unknown. This reinforces the importance of the existing precautions that have been introduced to reduce the risk of transmission of vCJD infection by blood and blood products . No cases of vCJD have been associated with fractionated plasma products. The small group of living recipients of vCJD-implicated blood transfusion in the UK have been informed of their potential exposure to vCJD by blood transfusion, asked to take certain precautions to reduce the risk of onward person-to-person transmission of vCJD during health care, and offered specialist neurological evaluation and advice.
This article has been adapted from reference 1
SEE ALSO ;
HPA Press Statement 18 January 2007 4th case of variant CJD infection associated with blood transfusion
ONCE again I must warn you that the USA is in a most unique situation, one of unknown circumstances with human and animal TSE. THE USA has the most documented TSE in different species to date, with substrains growing in those species (BSE/BASE in cattle and CWD in deer and elk, there is evidence here with different strains), and we know that sheep scrapie has over 20 strains of the typical scrapie with atypical scrapie documented and also BSE is very likely to have passed to sheep. all of which have been rendered and fed back to animals for human and animal consumption, a frightening scenario. WE do not know the outcome, and to play with human life around the globe with the very likely TSE tainted blood and tissue from the USA bovine, in my opinion is like playing Russian roulette, of long duration, with potential long and enduring consequences, of which once done, cannot be undone. These are the facts as I have come to know through daily and extensive research of TSE over 9 years, since 12/14/97. I tried to warn back in 2001, at the infamous Jan. 9, 2001 50 STATE BSE CONFERENCE CALL that the USA indeed was still feeding ruminant protein to 'tissue and blood donor herds', to no avail.
I do not pretend to have all the answers, but I do know to continue to believe in the ukbsenvcjd only theory of transmission to humans of only this one strain from only this one TSE from only this one part of the globe, will only lead to further failures, and needless exposure to humans from all strains of TSE, and possibly many more needless deaths from TSE via a multitude of proven routes and sources via many studies with primates and rodents and other species. ...
WE have known about risk factors of Scrapie Associated Fibers i.e. SAFs and ignored the '1968 MEDICINE ACT' ;
The BSE Inquiry / Statement No 477 Professor Sir James Armour Issued 07/07/1999
Although the letter from the BSE Inquiry requesting evidence was addressed to me, I have presented the course of events as handled by the VPC under my chairmanship. There was very good agreement between the Committee and myself on the advice given to the Medicines Unit, VMD and the Licensing Authority. Advice given through 1988 and 1989 centred on the development of Guidelines, both UK and European, in relation to the source and tissues of origin of materials used in the manufacture of veterinary products (and their sterilisation).
Answers to Specific Considerations
Outlined in Annex B of BSE Inquiry Letter of 7th April 1999
1. The interaction which you and/or the Committee of which you were a member had with the Department of Health and the various bodies constituted to advise it (Medicines Control Agency, Committee for Safety of Medicines, the Biologicals Sub- Committee, the Safety, Efficacy and Adverse Reactions Committee and the BSE Working Group). In particular, to what extent were information and ideas shared? Who instigated such action, in what forum did it take place and how was it structured? What was the outcome?
The only formal interaction that I or other members of the VPC had with DoH was through the representatives of DoH who attended VPC meetings. Any information from the other committees mentioned came via officials of MAFF, CVL or VMD, who had attended meetings of the Biological Sub-Committee of CSM and the BSE Working Group.
2. The information and knowledge which was in the possession of the committee of which you were a member regarding bovine and ovine materials in veterinary medicines prior to the identification of BSE in cattle.
Information was contained in individual licence applications granted after the 1968 Act [L12 Part A].
3. The approach subsequently taken to gathering, collating and analysing information as to the bovine and ovine ingredients in veterinary medical products.
Following the issue of the 1989 Guidelines on Spongiform Encephalopathies of Bovine, Ovine and Caprine Origin: Guidance on Good Manufacturing Practice and Request for Information [YB89/3.15/4.1-4.4], these were rigorously applied by the VPC to all new applications seen and to the products seen under the review of products licensed prior to 1984. Following collation and analysis of the returns on the questionnaires issued by VMD in March 1989, existing products were treated in the same way.
4. The formulation of the joint Committee for the Safety of Medicines/Veterinary Products Committee Guidelines for Industry issued in March 1989 and of any revision of these guidelines.
These guidelines were originally drafted by officials at the Medicines Unit, CVL and their counterparts at the Department of Health. They were then considered by the CSM and the VPC at individual meetings and, with a few suggested amendments, approved. These were superseded by CVMP Guidelines first published in January 1993
[YB93/1.00/4.1-4.6]. 5. The procedures adopted and action taken to ensure compliance with those guidelines. In particular, what policy was adopted with regard to manufacturers' existing stocks of medicinal products which contained bovine ingredients and what information was gathered as to manufacturers' compliance with that policy? What structures were adopted for ensuring compliance in general? Compliance was handled by VMD. The VPC received reports where there was a potential problem with compliance and advice was offered (see [YB90/11.00/5.1-5.2] and (Annex 12)).
6. The policy adopted in relation to the licensing of veterinary medicines and the changes in that policy over the relevant period.
The main changes relate to those recommended in the 1989 Guidelines [YB89/3.15/4.1- 4.4] and those produced by the CVMP in 1993 [YB93/1.00/4.1-4.6]. The source and origins of tissue material used in veterinary medicines, in particular bovine material, became key quality and safety issues.
7. Research undertaken or investigations made in order to assess the risk to cattle and/or other animals and/or humans from the use of medicines (veterinary or otherwise) containing bovine material. In particular, what assessment was made of the risks associated with different routes of infectivity?
Neither I nor, to my knowledge any VPC member, recommended any particular research in relation to BSE/veterinary medicines. Risks associated with different routes of infectivity were dealt with on a product-byproduct application basis. I and the VPC members were aware of the order of infectivity identified for scrapie from previous studies and emphasised in the CVMP guidelines of 1993. This was based on a titration of infectivity in mice by the intracerebral route.
8. What consideration if any was given to the risk associated with: (a) the use of bovine pituitary hormones, both to stimulate ovulation in cattle and otherwise and (b) the use of ovine materials in veterinary medicines, both in the period before and after the identification of BSE in cattle?
a. The VPC considered possible contamination of medicines with the BSE agent in July 1988 while assessing guidelines for the review of products containing hormones at the request of the Medicines Unit. The need for any risk of contamination with BSE to be considered with substances derived from glandular extracts intended for use in the treatment of ruminants was highlighted during the discussions concerning hormonal products in 1988 already referred to (See Paragraph 6 - Chronology of the BSE discussions at VPC). This discussion included bovine pituitary hormones. b. The need to avoid the use of ovine brain material, or indeed, any ovine material with the potential to contaminate medicines with the scrapie agent is dealt with under MAL67 - MAFF's 1983 guide to the use of substances of animal origin in the manufacture of veterinary vaccines [YB83/6.00/1.1-1.4]. As mentioned previously, risk was assessed with individual product applications. The Committee and I were aware that scrapie had been disseminated via a louping ill vaccine (I think in the late 1940s or early 1950s) in which brain and spleen tissue from scrapie-infected sheep had been inadvertently incorporated.
The case of company Z
Whilst the Inquiry revealed some of the secret workings of government, pharmaceutical companies have been protected by confidentiality clauses in the 1968 Medicines Act. The Inquiry was warned not to mention their names-instead the word "redacted" appears in the transcripts.
The Inquiry heard how investigations found there were 111 medicines administered by injection using the most risky by-products-brain and lymph. Most were made from imported material, but a range of homeopathic medicines and surgical sutures were not. The sutures used for sewing up tissues after operations were manufactured by the main British supplier referred to as "Z". They were made from cleaned cow intestines that the company processed at the rate of 2,500 a day. Against the advice of their own guidelines, officials renewed the licence on condition the company used intestines from clean beef cattle 18 months to two years old.
A minority recommended the use of intestines from BSE-free countries. The Inquiry was shown minutes where officials pointed out that "the agreement with the Company is 'confidential' so that there will be no direct comparisons" between the conditions they had set and the recent ban on offals, including intestines, for human consumption. Four years later, government officials announced that a study had detected BSE infectivity at the end of the small intestine from calves as young as six months old.
By July 1992 the BSE Inquiry was told all vaccines available in Britain fully complied with the guidelines and did not use British cattle by-products. By the end of the same year 40,000 cattle had shown symptoms of BSE. The number incubating BSE was much larger. But what of the stocks of vaccines? According to the Daily Telegraph, the BSE Inquiry has failed to establish what happened to them and "pharmaceutical companies have so far declined to volunteer the information". One Inquiry spokesperson said, "It is possible that we will never know whether all these vaccines were destroyed or whether they were used." All the Labour Health Minister, Tessa Jowell would say is they were "not disposed of or discontinued". ...end
IATROGENIC DISEASE IN ANIMALS
Private BSE Consultant
Veterinary Laboratories Agency, United Kingdom
There have been two reported incidents of iatrogenic disease in animals, both involving scrapie. One was in Great Britain (Gordon, Brownlee and Wilson, 1939, Gordon 1946, 1959) the other in Italy (Capucchio et al, 1998, Agrimi et al, 1999). Both resulted from infection being introduced into vaccines, louping ill vaccine in Great Britain, Mycoplasma agalactiae vaccine in Italy. Each of these vaccines was prepared from tissues that included sheep brain. In both episodes it seems most likely that natural scrapie infection was present unknowingly in some brains used for the purpose. Once prepared and having passed all the conventional vaccine tests large numbers of sheep in Great Britain, and goats and some sheep in Italy were inoculated. After the necessary incubation period large numbers (> 1,000 in each case) of inoculated animals came down with scrapie. In the meantime some inoculated clinically healthy goats and sheep may have entered food and feed chains or have been used for other purposes. In the British outbreak there appears to have been no consequence for humans who may have consumed infected sheep. It is too early to say what may be the consequences in Italy but measures have been taken to reduce any risk there may have been. .........end
Louping-ill vaccine documents from November 23rd, 1946 FULL TEXT
THE VETERINARY RECORD
516 No 47. Vol. 58
November 23rd, 1946
NATIONAL VETERINARY MEDICAL ASSOCIATION OF GREAT BRITAIN AND IRELAND
ANNUAL CONGRESS, 1946
The annual Congress, 1946, was held at the Royal Veterinary College, Royal College Street, London, N.W.I. from September 22nd to September 27th.
[skip to scrapie vaccine issue...tss]
Papers Presented to Congress
SNIP...FULL TEXT ;
although 176 products do _not_ conform to the CSM/VPC guidelines.
8. The Secretary of State has a number of licences. We understand that the inactivated polio vaccine is no longer being used. There is a stock of smallpox vaccine. We have not been able to determine the source material. (Made in sheep very unlikely to contain bovine ingredients).
Draft cover letter to product licence holders (considered by Human and Vet Medicines including deer)
Iatrogenic exposure of scrapie has probably occurred twice. The first report determined that
the vehicle was a louping ill vaccine prepared from sheep tissues and this infected a large
number of sheep sheep (Gordon, 1946, Greig, 1950). The second was more recent and in this
case a vaccine against Mycoplasma agalactiae prepared from sheep tissues was incriminated
(Agrimi et al 1999, Capucchio, 1998) but not all outbreaks could be linked to the use of the
vaccine. In this episode goats were predominantly affected10.
5.3.3 The greatest risk, in theory, would be from parenteral injection of material derived from bovine brain or lymphoid tissue. Medicinal products for injection or surgical implantation which are prepared from bovine tissues, or which utilise bovine serum albumin or similar agents in their manufacture, might also be capable of transmitting infectious agents. All medicinal products are licensed under the Medicines Act by the Licensing Authority following guidance, for example from the Committee on Safety of Medicines (CSM), the Committee on Dental and Surgical Materials (CDSM) and their subcommittees. The Licensing Authority have been alerted to potential concern about BSE in medicinal products and will ensure that scrutiny of source materials and manufacturing processes now takes account of BSE agent.
The documents below were provided by Terry S. Singeltary Sr on 8 May 2000. They are optically character read (scanned into computer) and so may contain typos and unreadable parts.
TIP740203/l 0424 CONFIDENTIAL
Mr Cunningham CMP3 From: D O Hagger MBI Dr Salisbury MED/IMCD3 Mr Burton PD/STB/PG1B B/17/2 Date: 15.02.1989 Mr Dudley PD/AD4
BOVINE SPONGIFORM ENCEPHALOPATHY
1. The purpose of this minute is to alert you to recent developments on BSE as they affect medicines and to invite representatives to a meeting in Market Towers on 22 February 1989.
2. The report of the Working Party on Bovine Spongiform Encephalopathy (BSE) was submitted by the CMO to the Secretary of State for Health and Minister for Agriculturer on 9 February.
3. The summary at the end of the report records, inter alia: 'we have drawn the attention of the Licensing Authority to the potential of transfer of BSE agent in human and veterinary medicinal products. In paragraph 7 of his submission (Annex A), the CMO notes:
"I am also putting work urgently in hand to satisfy myself that everything possible has been done to ensure .... that transfer of the BSE agent in human and veterinary medicinal products does not occur."
4. The Veterinary products Committee meets on 16 February and The committee on Safety of Medicines on 23 February when each will be considering a draft of some joint guidelines for manufacturers of medicinal products which use bovine material as an ingredient or an intermediate in the manufacturing process (Annex B).....
6. Although a wide range of medicines may be implicated - and the present proposal is to write to companies for more information - an "instant" telephone survey of manufacturer of vaccines used for children has already been undertaken in response to a request from Dr Harris. The results are in Dr Adams' minute of 14 February (Annex C) - the proviso in his second paragraph, last sentence should be noted.
MF580439/1 0584 SOUTHWOOD REPORT: BSE AND MEDICINAL PRODUCTS
1. I attach a list of questions on BSE and medicines compiled with the aim of providing question and answer briefing to DH and MAFF Ministers upon publication of the Southwood Report. I have suggested names of those who may be able to provide answers.
All recipients are invited to consider which if any important areas have been missed. Also attached is copy QA briefing being proposed by MAFF. I understand MAFF have produced General QA briefing on the reports as a whole.
MF580439/1 0585 Question
1. Which medicines are affected? (person to provide reply) Dr. Jefferys
2. Are the risks greater with some medicines than others? Dr. Jefferys
3. Why are medicines affected? Dr. Jefferys
4. Are some affected products available over the counter from pharmacies or shops? Dr. Purves
5. Are only UK products at risk? Dr. Jefferys
6. Are existing stocks safe? Dr. Jefferys
7. Are pre 1980 stocks available? Mr. Burton
8. Are these alternatives to the use of bovine material? Dr. Purves
9. Why can't we throw away suspect stock and import or manufacture safe medicines? Dr. Jefferys
10. Which patients are at risk? Dr. Jefferys
11. Are some patients particularly vulnerable? Dr Jefferys
12. What risks exist to those who have already used these medicines? Dr. Jefferys
13. HOW might patients be affected? Dr. Jefferys
14. Can BSE be transmitted to patients by medicines? Dr. Jefferys
15. How long will it be before risks are quantified? Dr. Jefferys
100 89/02.17/10.2 MF580439/1 0586
16. What research is going on to find out if medicines can transmit this disease and if any patients have been affected? Dr Jefferys
17. Could recent cases of Creuuzfeld Jacob Disease have been caused by transmission of BSE through medicines? Dr. Jefferys
18. What action is the Licensing Authority taking to ensure proper scrutinising of source materials and manufacturing processes? Dr. Jefferys/Dr. Purves
19. Are the guidelines practical? Dr. Jefferys/Dr. Purves
20. Will the guidelines remove the risk? Dr. Jefferys
21. How will the guidelines be enforced? Dr. Jefferys/Dr. Purves
22. How soon will they come into force? Dr. Jefferys
23. Will the guidelines be published? Mr. Hagger
24. What is being done to reassure patients, parents etc? Mr. Hagger/Dr. Salisbury
25. What advice is being given to doctors, pharmacists etc? Mr. Hagger
26. What advice is the Government giving about its vaccination programme? Dr. Salisbury
27. Is the vaccination programme put at risk because of BSE? Dr. Salisbury
Q. Will government act on this?
A. Yes - thymus is not used in preparation of baby foods but it is contacting all manufacturers to seek their urgent views on use of kidneys and liver from ruminants. Will consider any necessary measures in the light of their response.
Q. Can medicines spread BSE to other cattle/animals?
A. The report describes any risks as remote.
Q. How can risks be avoided?
A. In liaison with the DOH the Veterinary Products Committee is examining guidelines for the veterinary pharmaceutical industry which will be issued shortly.
Q. What will Guidelines say?
A. In essence they call for non-bovine sources to be used if possible, including synthetic material of biotechnological origin. Where this is not possible the industry should look for sources which are free of BSE and which are collected in a manner which avoids risk of contamination by the BSE agent.
89/02.17/10.4 MF580439/1 0588
A. Bovine source material is used in [garbled, cannot read...TSS] and some other medicines.
Q. How many medicines are involved?
A. Computer records show that about 300 of the 3,050 veterinary medicines licensed in the U.K. are manufactured directly from bovine source material. However, other medicines may be produced from bovine sources and a letter is going to all license holders so that a comprehensive list can be drawn up.
89/06.19/8.1 BSE3/1 0191 Hr J Maslin (MAFF) Ref: Maslin3g
From: Dr H Pickles Med SEB/B Date: 3 July 1989
CATTLE BY-PRODUCTS AND BSE
I was interested to see the list of by-products sent to the HSE. Those of particular concern included:
* small intestines: sutures (I thought the source was ovine but you are checking this)
* spinal cord: pharmaceuticals
* thymus: pharmaceuticals
Are you able to give me more information on which UK manufacturers use these materials? Our proposed ban on bovine offal for human consumption would not affect these uses, I assume.
Id No. 1934/RD/1 89/08.10/6.1 117A
BOVINE SPONGIFORM ENCEPHALAPATHY MEETING HELD ON 21 AUGUST 1989 AT 2;15 IN ROOM 720 Miss M Duncan (Chairman) Mr W Burton Dr E Hoxey Mrs J Dhell Ms K Turner Dr S Whittle Mr N Weatherhead ... 5. The MCA had sent 2700 questionnaires out, 1,124 had made valid returns; of these 122 use animal material of some kind and there are 582 products involved. ... 6. The MCA/BSE working group will meet on 6th September. Their aim is to review responses from professional officers in MCA who have suggested seven categories of importance (with 1 being the most important} for medical products:
ID 2267/NRE/1 89/08.21/10.1
1. Products with Bovine brain/lymph tissue administered by injection.
2. Products with bovine tissue other than brain/lymph administered by inection.
3. Tissue implants/open wound dressing/surgical materials/dental and ophthlamic products with bovine ingredients.
4. Products with bovine ingredients administered topically.
5. Products with bovine ingredients administered orally.
6. Products with other animal/fish/insect/bird ingredients administered by injection/topically/oral routes.
7. Products with ingredients derived from animal material by chemical processing (eg stearic acid, gelatine, lanolin ext.
The BSE working group will decide which of these are important, and should be examined more closely, and which categories can be eliminated.
The responses by the companies were presented by Ms Turner and were categorised by MCA standards, the products that were discussed were all low volume usage products eg sutures, heart valves.
8. As the responses included some materials of human origin it was decided that more information should be sought about CJD. There had been 2 recent deaths reported associated with human growth hormone. These were being investigated.
9. Re-editing of the Paper on "Incubation of Scrapie-like Agents"
It was suggested that the document could be sent out to companies with the non-standard sterilization Document. The document could have severe implications on the companies whose products have a high risk factor as decided by the MCA working group....
11. The Need for a list of High Priority Implantables The commitee decided that no list is necessary as all implantables, including ones from a human source are of high priority. Concern was shown over Killingbeck who use human material but had not yet responded. The company will be chased for a response. Concern was shown over the fact that there may be other scrapie-like organisms in other animals and further enquiries should be made.
BOVINE MATERIAL USED IN THE MANUFACTURE OF SURGICAL IMPLANTS AND BLOOD CONTACT MEDICAL DEVICES
Glutaraldehyde, formaldehyde, and ethylene oxide are used in the sterilization of these devices.
However, glutaraldehyde 4,10,12,19 formaldehyde 5,10,11,13,19 and ethylene oxide 19,23 are all reported to be ineffective methods for sterilization of material infected with the agents of CJD or scrapie.
Previous advice and research using the agents of CJD and scrapie, has concentrated on the decontamination of equipment; protection of health care workers from contaminated human material; human growth hormone; and dura mater. The methods developed may not be directly applicable or transferable to material of bovine origin for use in human implantation.
2334q/RD/7 89/08.21/10.10 BSE11/2 020 SC1337
DEPARTMENT OF HEALTH AND SOCIAL SECURITY Richmood House 79 Whitehall, London SW1A 2NS Telephone 01-210-3000 From the Chief Medical Officer Sir Donald Acheson KBE DM DSc FRCP FFCM FFOM
Mr K C Meldrum Chief Veterinary Officer Ministry of Agriculture, Fisheries and Food Government Buildings Hook Rise South Tolworth Surbiton Surrey KT6 7NG
3 January 1990
Dear Mr. Meldrum,
BOVINE SPONGIFORM ENCEPHALOPATHY
You will recall that we have previously discussed the potential risks of BSE occurring in other Countries as a result of the continuing export from the UK of meat and bone that may be contaminated by scrapie or possibly BSE.
I remain concerned that we are not being consistent in our attempts to contain the risks of BSE. Having banned the feeding of meat and bone meal to ruminants in 1988, we should take steps to prevent these UK products being fed to ruminants in other countries. This could be achieved either through a ban on the export of meat and bone meal, or at least by the proper labelling of these products to make it absolutely clear they should not be fed to ruminants. Unless some such action is taken the difficult problems we have faced with BSE may well occur in other countries who import UK meat and bone meal. Surely it is short sighted for us to risk being seen in future as having been responsible for the introduction of BSE to the food chain in other countries.
I would be very interested to hear how you feel this gap in the present prcautionary measures to eliminate BSE should be closed. We should be aiming at the global elimination of this new bovine disease. The export of our meat and bone meal is a continuing risk to other countries.
Signed Sincerely Donald Acheson
Did the US import fetal calf serum and vaccines from BSE-affected countries?
3002.10.0040: FETAL BOVINE SERUM (FBS) U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date (Customs Value, in Thousands of Dollars) (Units of Quantity: Kilograms)
<--- Dec 1998 ---> <--- 1998 YTD ---> Country Quantity Value Quantity Value ================================================================= WORLD TOTAL . . . . . . . 2,727 233 131,486 8,502 Australia . . . . . . . . --- --- 19,637 2,623 Austria . . . . . . . . . --- --- 2,400 191 Belgium . . . . . . . . . --- --- 17 32 Canada . . . . . . . . . 900 110 30,983 3,220 Costa Rica . . . . . . . 500 20 4,677 169 Federal Rep. of Germany --- --- 105 21 Finland . . . . . . . . . 1 8 9 83 France . . . . . . . . . --- --- 73 7 Guatemala . . . . . . . . --- --- 719 42 Honduras . . . . . . . . --- --- 1,108 88 Israel . . . . . . . . . --- --- 24 165 Netherlands . . . . . . . --- --- 1 5 New Zealand . . . . . . . 26 5 65,953 913 Panama . . . . . . . . . --- --- 1,195 64 Switzerland . . . . . . . 971 8 1,078 23 United Kingdom . . . . . 329 82 743 756 Uruguay . . . . . . . . . --- --- 2,764 98 ---------------------------------------------------------- 3002.20.0000: VACCINES FOR HUMAN MEDICINE U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date (Customs Value, in Thousands of Dollars) (Units of Quantity: Kilograms)
<--- Dec 1998 ---> <--- 1998 YTD ---> Country Quantity Value Quantity Value ================================================================= WORLD TOTAL . . . . . . . 25,702 26,150 550,258 378,735 Austria . . . . . . . . . --- --- 45 225 Belgium . . . . . . . . . 14,311 12,029 248,041 199,036 Canada . . . . . . . . . 1,109 1,527 15,798 16,305 Denmark . . . . . . . . . 80 234 246 682 Federal Rep. of Germany 1,064 4,073 12,001 6,329 France . . . . . . . . . 3,902 4,859 87,879 92,845 Ireland . . . . . . . . . --- --- 120 478 Italy . . . . . . . . . . --- --- 2,359 81 Japan . . . . . . . . . . 445 1,903 11,350 11,298 Netherlands . . . . . . . --- --- 94 6 Republic Of South Africa --- --- 2 1 Spain . . . . . . . . . . --- --- 60 30 Switzerland . . . . . . . 716 353 9,303 4,271 United Kingdom . . . . . 4,075 1,172 162,960 47,148 ---------------------------------------------------------- 3002.30.0000: VACCINES FOR VETRINARY MEDICINE U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date (Customs Value, in Thousands of Dollars) (Units of Quantity: Kilograms)
<--- Dec 1998 ---> <--- 1998 YTD ---> Country Quantity Value Quantity Value ================================================================= WORLD TOTAL . . . . . . . 6,528 237 87,149 2,715 Canada . . . . . . . . . --- --- 2,637 305 Federal Rep. of Germany --- --- 104 5 Netherlands . . . . . . . 138 64 472 192 New Zealand . . . . . . . 6,390 173 83,882 1,895 United Kingdom . . . . . --- --- 54 318
SEE HEART VALVES ;
My submission to FDA about this ;
PDF]Freas, William TSS SUBMISSION
File Format: PDF/Adobe Acrobat -
Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary
Sr. [firstname.lastname@example.org] Monday, January 08,200l 3:03 PM freas ...
Asante/Collinge et al, that BSE transmission to the 129-methionine
genotype can lead to an alternate phenotype that is indistinguishable
from type 2 PrPSc, the commonest _sporadic_ CJD;
Date: Sun, 7 Jan 2001 09:45:19 -0800
Reply-To: Sustainable Agriculture Network Discussion Group <[log in to unmask]>
Sender: Sustainable Agriculture Network Discussion Group <[log in to unmask]>
From: Beth von Gunten <[log in to unmask]>
Subject: [BSE] FDA/IMPORTANT NOTICE: 50 STATE CONFERENCE CALL Content-Type: text/plain; charset="us-ascii" ; format="flowed"
IMPORTANT NOTICE: 50 STATE CONFERENCE CALL - BSE
TUESDAY, JANUARY 9, 2001 1:00-2:00 PM EST CALL: 1-888-273-9887
A special "50 STATE CONFERENCE CALL" to discuss BSE (Bovine Spongiform Encephalopathy) issues for Food and Drug Administration (FDA) regulated animal feed products in the United States and imported animal feeds. The conference call will discuss the FDA proposed response to the current BSE issue and the assistance needed from state feed and agriculture programs. THIS ISSUE MAY IMPACT ALL STATES AND ALL ANIMAL FEED AND PRODUCTION INDUSTRIES.
The 50 State call is scheduled for Tuesday, January 9, 2001 from 1:00-2:00 pm EST. Any state agency responsible for animal feed issues wishing to participate should call 1-888-273-9887 and ask to be connected to the "50 State BSE Call". The conference host operator will explain how to participate, including asking questions during the call. If possible, please coordinate within your state to utilize only one phone line per state agency.
We request that you forward this message to your agency management and feed coordinators or other agencies or departments who may be responsible for any animal feed issues related to FDA regulated products.
The agenda will be as follows:
1. Center For Veterinary Medicine (FDA) - Discussion of the problem related to BSE events in Europe and the impact on US feed ingredients for animals and feed operations. Discussion of the proposed actions/inspections/compliance of licensed and unlicensed feed mills, commercial feed manufacturers, animal feed imports, renderer's, protein blenders, on-farm mixers, and ruminant feeders.
2. Office of Regional Operations (FDA) - Discussion of contracting/working with states to inspect the universe of feed mills/industry for "Animal Proteins Prohibited from Use in Animal Feed". Discussion of working with FDA field offices.
3. Questions and answers.
Richard H. Barnes, Director Division of Federal-State Relations (HFC-150) 5600 Fishers Lane Room 1207 Rockville, Md. 20857 ph: (301) 827-6906 FAX: (301) 443-2143 Email: [log in to unmask]
Subject: U.S.A. - 50 STATE BSE CONFERENCE CALL JAN. 9, 2001 (my notes) Date: January 10, 2001 at 1:36 pm PST
Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001 Date: Tue, 9 Jan 2001 16:49:00 -0800 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000035/!x-usc:mailto:BSE-L@uni-karlsruhe.de
######### Bovine Spongiform Encephalopathy #########
Greetings List Members,
I was lucky enough to sit in on this BSE conference call today and even managed to ask a question. that is when the trouble started.
I submitted a version of my notes to Sandra Blakeslee of the New York Times, whom seemed very upset, and rightly so.
"They tell me it is a closed meeting and they will release whatever information they deem fit. Rather infuriating."
and i would have been doing just fine, until i asked my question. i was surprised my time to ask a question so quick.
(understand, these are taken from my notes for now. the spelling of names and such could be off.)
[host Richard Barns]
and now a question from Terry S. Singeltary of CJD Watch.
yes, thank you, U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?
[no answer, you could hear in the back ground, mumbling and 'we can't. have him ask the question again.]
could you repeat the question?
U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?
[not sure whom ask this] what group are you with?
[TSS] CJD Watch, my Mom died from hvCJD and we are tracking CJD world-wide.
[not sure who is speaking] could you please disconnect Mr. Singeltary
[TSS] you are not going to answer my question?
[not sure whom speaking]
from this point, i was still connected, got to listen and tape the whole conference. at one point someone came on, a woman, and ask again;
what group are you with?
CJD Watch and my Mom died from hvCJD we are trying to tract down CJD and other human TSE's world wide. i was invited to sit in on this from someone inside the USDA/APHIS and that is why i am here. do you intend on banning me from this conference now?
at this point the conference was turned back up, and i got to finish listening. They never answered or even addressed my one question, or even addressed the issue. BUT, i will try and give you a run-down for now, of the conference.
IF i were another Country, I would take heed to my notes, BUT PLEASE do not depend on them. ask for transcript from;
he would be glad to give you one ;-)
Rockville Maryland, Richard Barns Host
BSE issues in the U.S.,
How they were labelling ruminant feed?
The conference opened up with the explaining of the U.K. BSE epidemic winding down with about 30 cases a week.
although new cases in other countries were now appearing.
Look at Germany whom said NO BSE and now have BSE.
BSE increasing across Europe.
Because of Temporary Ban on certain rendered product, heightened interest in U.S.
A recent statement in Washington Post, said the New Administration (old GW) has a list of issues. BSE is one of the issues.
BSE Risk is still low, minimal in U.S. with a greater interest in MBM not to enter U.S.
HOWEVER, if BSE were to enter the U.S. it would be economically disastrous to the render, feed, cattle, industries, and for human health.
(human health-they just threw that in cause i was listening. I will now jot down some figures in which they told you, 'no need to write them down'. just hope i have them correct. hmmm, maybe i hope i don't ???)
80% inspection of rendering
*Problem-Complete coverage of rendering HAS NOT occurred.
sizeable number of 1st time FAILED INITIAL INSPECTION, have not been reinspected (70% to 80%).
Compliance critical, Compliance poor in U.K. and other European Firms.
Gloria Dunason Major Assignment 1998 goal TOTAL compliance. This _did not_ occur. Mixed level of compliance, depending on firm.
Rendering FDA license and NON FDA license
system in place for home rendering & feed 76% in compliance 79% cross contamination 21% DID NOT have system 92% record keeping less than 60% total compliance
279 inspectors 185 handling prohibited materials
Renderer at top of pyramid, significant part of compliance. 84% compliance
failed to have caution statement render 72% compliance & cross contamination caution statement on feed, 'DO NOT FEED TO CATTLE'
56 FIRMS NEVER INSPECTED
1240 FDA license feed mills 846 inspected
"close to 400 feed mills have not been inspected"
80% compliance for feed.
10% don't have system.
NON-FDA licensed mills There is NO inventory on non licensed mills. approximately 6000 to 8000 Firms ??? 4,344 ever inspected. "FDA does not have a lot of experience with"
40% do NOT have caution statement 'DO NOT FEED'.
74% Commingling compliance
"This industry needs a lot of work and only half gotten to"
"700 Firms that were falitive, and need to be re-inspected, in addition to the 8,000 Firms."
Quote to do BSE inspection in 19 states by end of January or 30 days, and other states 60 days. to change feed status??? Contract check and ask questions and pass info.
At this time, we will take questions.
[I was about the third or fourth to ask question. then all B.S.eee broke loose, and i lost my train of thought for a few minutes. picked back up here]
someone asking about nutritional supplements and sourcing, did not get name. something about inspectors not knowing of BSE risk??? the conference person assuring that Steve Follum? and the TSE advisory Committee were handling that.
Some other Dr. Vet, whom were asking questions that did not know what to do???
[Dennis Wilson] California Food Agr. Imports, are they looking at imports?
[Conference person] they are looking at imports, FDA issued imports Bulletin.
[Linda Singeltary ??? this was a another phone in question, not related i don't think] Why do we have non-licensed facilities?
(conference person) other feed mills do not handle as potent drugs???
Dennis Blank, Ken Jackson licensed 400 non FDA 4400 inspected of a total of 6000 to 8000,
(they really don't know how many non licensed Firms in U.S. they guess 6000 to 8000??? TSS)
Linda Detwiler asking everyone (me) not to use emergency BSE number, unless last resort. (i thought of calling them today, and reporting the whole damn U.S. cattle herd ;-) 'not'
Warren-Maryland Dept. Agr. Prudent to re-inspect after 3 years. concerned of Firms that have changed owners.
############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############
JANUARY 9, 2001
50 STATE BSE CONFERENCE CALL
ALL the warnings have been there, most just chose to ignore them, now only time will tell who has to pay the final price. sadly, some like Lester Crawford reaped the rewards of ignoring these risk factors $$$ you cannot put the wolf in guard of the hen house, and the fda, usda, aphis, fsis, et al are full of these wolves guarding the hen houses ;
Sentencing Is Delayed in Case Of Former FDA Commissioner ASSOCIATED PRESS
Former FDA Commissioner Lester Crawford's sentencing on charges he lied about his stock holdings was delayed Tuesday over questions about sentencing guidelines. Under a deal worked out between his attorney and federal prosecutors, Mr. Crawford had agreed earlier to a $50,000 fine and probation. Magistrate Judge Deborah A. Robinson asked the attorneys to explain why they didn't use certain federal sentencing guidelines in ... snip...end
no conflict of interest there right ???
WHAT else did old lester crawford lie about, and whom reaped what from that $$$
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;
The product known as mechanically separated beef, a product which may contain SRMs. Meat obtained by Advanced Meat Recovery (an automated system for cutting meat from bones), may be used since USDA regulations do not allow the presence of SRMs in this product.
The second interim final rule is designed to lower even further the risk that cattle will be purposefully or inadvertently fed prohibited protein. It was the feeding of such protein to cattle that was the route of disease transmission that led to the BSE epidemic in United Kingdom cattle in the 1980's and 1990's. This interim final rule will implement four specific changes in FDA's present animal feed rule. First, the rule will eliminate the present exemption in the feed rule that allows mammalian blood and blood products to be fed to other ruminants as a protein source. Recent scientific evidence suggests that blood can carry some infectivity for BSE.
Second, the rule will also ban the use of "poultry litter" as a feed ingredient for ruminant animals. Poultry litter consists of bedding, spilled feed, feathers, and fecal matter that are collected from living quarters where poultry is raised. This material is then used in cattle feed in some areas of the country where cattle and large poultry raising operations are located near each other. Poultry feed may legally contain protein that is prohibited in ruminant feed, such as bovine meat and bone meal. The concern is that spillage of poultry feed in the chicken house occurs and that poultry feed (which may contain protein prohibited in ruminant feed) is then collected as part of the "poultry litter" and added to ruminant feed.
Third, the rule will ban the use of "plate waste" as a feed ingredient for ruminants. Plate waste consists of uneaten meat and other meat scraps that are currently collected from some large restaurant operations and rendered into meat and bone meal for animal feed. The use of "plate waste" confounds FDA's ability to analyze ruminant feeds for the presence of prohibited proteins, compromising the Agency's ability to fully enforce the animal feed rule.
Fourth, the rule will further minimize the possibility of cross-contamination of ruminant and non-ruminant animal feed by requiring equipment, facilities or production lines to be dedicated to non-ruminant animal feeds if they use protein that is prohibited in ruminant feed. Currently, some equipment, facilities and production lines process or handle prohibited and non-prohibited materials and make both ruminant and non-ruminant feed -- a practice which could lead to cross-contamination.
To accompany these new measures designed to provide a further layer of protection against BSE, FDA will in 2004 step up its inspections of feed mills and renderers. FDA will itself conduct 2,800 inspections and will make its resources go even further by continuing to work with state agencies to fund 3,100 contract inspections of feed mill and renderers and other firms that handle animal feed and feed ingredients. Through partnerships with states, FDA will also receive data on 700 additional inspections, for a total of 3,800 state contract and partnership inspections in 2004 alone, including annual inspections of 100 percent of all known renderers and feed mills that process products containing materials prohibited in ruminant feed.
"We have worked hard with the rendering and animal feed production industries to try and achieve full compliance with the animal feed rule," said Dr. McClellan, "and through strong education and a vigorous enforcement campaign, backed by additional inspections and resources, we intend to maintain a high level of compliance." Dr. McClellan also noted that, in response to finding a BSE positive cow in Washington state December 23, FDA inspected and traced products at 22 facilities related to that positive cow or products from the cow, including feed mills, farms, dairy farms, calf feeder lots, slaughter houses, meat processors, transfer stations, and shipping terminals. Moreover, FDA has conducted inspections at the rendering facilities that handled materials from the positive cow, and they were found to be fully in compliance with FDA's feed rule.
To further strengthen protections for Americans, FDA/HHS intends to work with Congress to consider proposals to assure that these important protective measures will be implemented as effectively as possible.
FDA is also continuing its efforts to assist in the development of better BSE science, to achieve the same or greater confidence in BSE protection at a lower cost. For example, to enhance the ability of our public health system to detect prohibited materials in animal feed, FDA will continue to support the development and evaluation of diagnostic tests to identify prohibited materials. These tests would offer a quick and reliable method of testing animal feeds for prohibited materials and for testing other products for contamination with the agent thought to cause BSE.
FDA has publicly discussed many of the measures being announced today with stakeholders in workshops, videoconferences, and public meetings. In addition, FDA published an Advance Notice of Proposed Rulemaking in November 2002 (available online at
concerning possible changes to the animal feed rule.
Comprehensive information about FDA's work on BSE and links to other related websites are available at http://www.fda.gov.
STATEMENT BY LESTER M. CRAWFORD, D.V.M., PH.D. DEPUTY COMMISSIONER OF FOOD AND DRUGS DEPARTMENT OF HEALTH AND HUMAN SERVICES BEFORE THE COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY UNITED STATES SENATE
JANUARY 27, 2004
Mr. Chairman, Members of the Committee, thank you for the opportunity to participate in today's hearing on measures taken by the Federal government to safeguard human and animal health in the United States from Bovine Spongiform Encephalopathy (BSE) and the response to the finding of a BSE-positive cow in the State of Washington. I am Dr. Lester M. Crawford, Deputy Commissioner, Food and Drug Administration (FDA or the Agency).
The mission of FDA is to protect the public health by assuring the safety and efficacy of our nation's human and veterinary drugs, human biological products, medical devices, human and animal food supply, cosmetics, and radiation emitting products. In fulfilling this mission, FDA is the Agency responsible for assuring that all FDA-regulated products remain safe and uncompromised from BSE and related diseases. Many FDA-regulated products contain bovine ingredients, for example, heart valves, ophthalmic devices, dental products, wound dressings, injectable drugs, vaccines, soups, gravies, sausage casings, and animal feeds.
FDA has long been actively involved nationally and internationally in efforts to understand and prevent the spread of BSE. FDA collaborates extensively with the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Animal and Plant Health Inspection Service (APHIS) and the Food Safety and Inspection Service (FSIS) within the U.S. Department of Agriculture (USDA), Customs and Border Protection (CBP), the Environmental Protection Agency (EPA), other Federal agencies, state and local jurisdictions, and with affected industries and consumer groups. Many of these activities fit within the framework of the Department of Health and Human Service's (HHS or the Department) Bovine Spongiform Encephalopathy/Transmissible Spongiform Encephalopathy (BSE/TSE) Action Plan, which was released in August 2001. This collaboration over many years has enabled FDA to strengthen safeguards for FDA-regulated products and to respond quickly and effectively to the first case of BSE within the U.S.
The mission of the Agency is to protect the public health by assuring the safety and efficacy of our nation's human and veterinary drugs, human biological products, medical devices, human and animal food supply, cosmetics, and radiation emitting products. In fulfilling this mission, FDA is the Agency responsible for assuring that all FDA-regulated products remain safe and uncompromised from BSE and related diseases.
BSE is a progressive neurological disorder of cattle that results from infection by an unconventional transmissible agent, and was first diagnosed in the United Kingdom (U.K.) in 1986. Many FDA-regulated products contain bovine ingredients, for example, heart valves, ophthalmic devices, dental products, wound dressings, injectable drugs, vaccines, soups, gravies, sausage casings, and animal feeds and thus must be taken into consideration as part the effort to prevent infectivity by BSE.
FDA has a longstanding commitment to protecting consumers from BSE by following multiple measures designed to safeguard FDA-regulated products from possible contamination by the BSE agent. Under the Federal Food, Drug, and Cosmetic (FD&C) Act, FDA has the authority to prevent the adulteration and misbranding of FDA-regulated products. Further, for medical products that require pre-market approval (e.g., drugs under Section 505 and medical devices under Section 513 of the FD&C Act), FDA has addressed safety concerns related to BSE through requirements of the application and approval process.
The U.S. employs a robust multi-layered approach to preventing the introduction and amplification of BSE. While the goal of this approach is to achieve an extremely high level of compliance with each preventative measure, this multi-layered approach is designed to protect the U.S. consumer from exposure to the BSE infective material, and to date this approach has been working. Since 1989, USDA has prohibited the importation of live animals and animal products from BSE-positive countries. Since 1997, FDA has prohibited the use of certain mammalian proteins in the manufacture of ruminant feed. FDA continues to implement policies to keep safe all FDA-regulated products, including food, food ingredients, dietary supplements, drugs, vaccines, and cosmetics from risk of any BSE-contaminated bovine material. As a result of these multiple regulatory safeguards, the risk of exposure to BSE through products, FDA regulates remains extremely low in the U.S.
FDA's 1997 animal feed regulation forms the basis of the Agency's efforts to prevent the spread of BSE through animal feed. This rule prohibits the use of most mammalian protein in the manufacture of animal feeds for ruminants. FDA implemented this rule to establish in our country feeding practices consistent with the best science and epidemiological knowledge known at the time to prevent the spread of BSE throughout herds of U.S. cattle. A risk assessment sponsored by USDA and conducted by the Harvard Center for Risk Analysis, released in November 2001, identified FDA's feed ban as one of the primary safeguards against the spread of BSE in U.S. cattle.
To maximize protection afforded by the feed regulation, FDA has developed and implemented a BSE/Ruminant Feed Ban Inspection compliance program and established the goal of 100 percent compliance. FDA's strategy for achieving uniform compliance with the feed rule focuses on three areas: education, inspection, and enforcement. FDA and its state counterparts conduct, at least annually, targeted BSE inspections of 100 percent of known renderers, protein blenders, and feed mills processing products containing material prohibited from use in ruminant feed. Compliance by these establishments with FDA's feed rule is estimated to be at better than 99 percent. As of December 20, 2003, FDA had received over 26,000 inspection reports (6,404 for Fiscal Year 2003). The majority of these inspections (around 70 percent) were conducted by state officials for FDA, with the remainder conducted by FDA officials. The total number of inspection reports represents 13,672 firms, 1,949 of which are active and handle materials prohibited from use in ruminant feed. The 1,949 active firms that handle prohibited material have been inspected by FDA and, as of December 31, 2003, only five were found to have significant violations, resulting in official action indicated (OAI). FDA is working with these firms to bring them into compliance.
On December 23, 2003, FDA was notified by USDA of a presumptive-positive finding of BSE in a cow in Washington State. FDA immediately initiated its BSE Emergency Response Plan. As part of the plan, FDA has been coordinately closely with USDA so that we can effectively investigate this BSE case, trace the various products involved, and take the appropriate steps to protect the public. FDA investigators and inspectors located the high risk material rendered from the infected cow, and the rendering plants placed a hold on the rendered material, which is being disposed of appropriately. I am happy to report that all of the establishments inspected by FDA during the course of the investigation were in compliance with the feed ban. In addition, to help address the concerns of foreign governments and restore confidence in American products, FDA has participated, along with USDA, in numerous meetings and consultations with foreign governments since USDA surveillance found the BSE-positive cow.
In addition to new policies and regulations, new knowledge and tools gained through applied research can greatly help us to be more effective in our regulatory mission, such as protecting the country from BSE. Several of FDA's Centers, as well as many private laboratories, academic institutions, and other Federal agencies (most notably NIH) are also involved in significant research activities relating to TSEs. Basic areas requiring research include: increasing our understanding of prions, learning how prions are transmitted within a species and potentially between species, developing diagnostic tests for humans and animals, developing detection methods for use on regulated products, developing methods to increase or eliminate infectivity, and designing new treatments. We are optimistic about the promise of new technologies, such as better methods to quickly distinguish the species of proteins and sensors to detect abnormal prions in food. Development of these technologies can contribute significantly to the effort to prevent the spread of BSE and must be considered carefully when evaluating potential regulatory changes to address BSE.
At the time that FDA implemented the feed rule in 1997, the Agency also recognized that evolving, complex scientific and public health issues, particularly regarding BSE required the Agency to continue to assess and scrutinize the rule to ensure its integrity as a firewall against the potential for spread of BSE. To further explore ways the animal feed regulation could be improved in November 2002, FDA published an advance notice of proposed rulemaking (ANPR) soliciting information and views from the affected industries and the public on some potential changes to its current feed regulation, including ways that the animal feed regulation could be strengthened. Although the risk of exposure to BSE in the U.S. remains extremely low and the measures in place are working, as a result of the recently discovered infected cow in the state of Washington, the Agency is evaluating the appropriateness of additional science-based measures to further strengthen our current protections.
Yesterday, Department Secretary Tommy Thompson and FDA Commissioner Mark McClellan announced several additional public health measures to further strengthen the current robust safeguards that help protect Americans from exposure to the agent that causes BSE and help prevent the spread of BSE in U.S. cattle. These measures relate to both protections for foods intended for human consumption as well as additional measures to strengthen FDA's 1997 final rule regulating animal feed. With respect to human foods, FDA announced that it will extend to FDA-regulated foods, dietary supplements and cosmetics, restrictions on using specified risk materials that would complement the recent USDA announcements. Concerning animal feed, the Agency announced a series of measures designed to lower even further the risk that cattle will be purposefully or inadvertently fed "ruminant" proteins, including, eliminating an exemption in the feed rule that allows mammalian blood and blood products at slaughter to be fed to ruminants as a protein source; banning the use of "poultry litter" as a feed ingredient for cattle and other ruminants; prohibiting the use of "plate waste" as a feed ingredient for ruminants, including cattle; and taking steps to further minimize the possibility of cross-contamination of animal feed via equipment, facilities or production lines.
Finally, FDA is increasing its inspections of feed mills and renderers in 2004. Our 2001 base funding for BSE-related activities was $3.8 million. We shifted resources internally in 2001 and received a substantial increase from Congress in 2002. Our funded level for 2004 is currently approximately $21.5 million, almost a five-fold increase over the 2001 base. FDA will itself conduct 2,800 inspections and will make its resources go even further by working with state agencies to fund 3,100 contract inspections of feed mills and renderers and other firms that handle animal feed and feed ingredients. Through partnerships with states, FDA will also receive data on 700 additional inspections, for a total of 3,800 state contract and partnership inspections in 2004. These inspections would include 100 percent of all known renderers and feed mills that process products containing prohibited materials. The Agency looks forward to continuing to assist Congress as it evaluates the risks associated with BSE, identifies opportunities to promote technologies that will detect and prevent the spread of BSE, and considers science-based approaches to further strengthen regulatory protections and bolster the resources available to assist Federal, state, local and private efforts to assure that BSE does not present a threat to human or animal health in the U.S.
Background on Bovine Spongiform Encephalopathy (BSE) .................
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
PLEASE NOTE, WERE STILL WAITING for some of these BSE/TSE safeguards $$$
some of those promises above have still yet to be implemented, AND, the USDA/FDA et al are still feeding cows to cows in 2006 ;
Subject: MAD COW FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL, TN, AND WV
Date: September 6, 2006 at 7:58 am PST
a) EVSRC Custom dairy feed, Recall # V-130-6; b) Performance Chick Starter, Recall # V-131-6; c) Performance Quail Grower, Recall # V-132-6; d) Performance Pheasant Finisher, Recall # V-133-6. CODE None RECALLING FIRM/MANUFACTURER Donaldson & Hasenbein/dba J&R Feed Service, Inc., Cullman, AL, by telephone on June 23, 2006 and by letter dated July 19, 2006. Firm initiated recall is complete. REASON Dairy and poultry feeds were possibly contaminated with ruminant based protein. VOLUME OF PRODUCT IN COMMERCE 477.72 tons DISTRIBUTION AL ______________________________
PRODUCT a) Dairy feed, custom, Recall # V-134-6; b) Custom Dairy Feed with Monensin, Recall # V-135-6. CODE None. Bulk product RECALLING FIRM/MANUFACTURER Recalling Firm: Burkmann Feed, Greeneville, TN, by Telephone beginning on June 28, 2006. Manufacturer: H. J. Baker & Bro., Inc., Albertville, AL. Firm initiated recall is complete. REASON Possible contamination of dairy feeds with ruminant derived meat and bone meal. VOLUME OF PRODUCT IN COMMERCE 1,484 tons DISTRIBUTION TN and WV
Subject: MAD COW FEED RECALLS ENFORCEMENT REPORT FOR AUGUST 9, 2006 KY, LA, MS, AL, GA, AND TN 11,000+ TONS Date: August 16, 2006 at 9:19 am PST RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II ______________________________ PRODUCT Bulk custom made dairy feed, Recall # V-115-6 CODE None RECALLING FIRM/MANUFACTURER Hiseville Feed & Seed Co., Hiseville, KY, by telephone and letter on or about July 14, 2006. FDA initiated recall is ongoing. REASON Custom made feeds contain ingredient called Pro-Lak which may contain ruminant derived meat and bone meal. VOLUME OF PRODUCT IN COMMERCE Approximately 2,223 tons DISTRIBUTION KY ______________________________ PRODUCT Bulk custom made dairy feed, Recall # V-116-6 CODE None RECALLING FIRM/MANUFACTURER Rips Farm Center, Tollesboro, KY, by telephone and letter on July 14, 2006. FDA initiated recall is ongoing. REASON Custom made feeds contain ingredient called Pro-Lak which may contain ruminant derived meat and bone meal. VOLUME OF PRODUCT IN COMMERCE 1,220 tons DISTRIBUTION KY ______________________________ PRODUCT Bulk custom made dairy feed, Recall # V-117-6 CODE None RECALLING FIRM/MANUFACTURER Kentwood Co-op, Kentwood, LA, by telephone on June 27, 2006. FDA initiated recall is completed. REASON Possible contamination of animal feed ingredients, including ingredients that are used in feed for dairy animals, with ruminant derived meat and bone meal. VOLUME OF PRODUCT IN COMMERCE 40 tons DISTRIBUTION LA and MS ______________________________ PRODUCT Bulk Dairy Feed, Recall V-118-6 CODE None RECALLING FIRM/MANUFACTURER Cal Maine Foods, Inc., Edwards, MS, by telephone on June 26, 2006. FDA initiated recall is complete. REASON Possible contamination of animal feed ingredients, including ingredients that are used in feed for dairy animals, with ruminant derived meat and bone meal. VOLUME OF PRODUCT IN COMMERCE 7,150 tons DISTRIBUTION MS ______________________________ PRODUCT Bulk custom dairy pre-mixes, Recall # V-119-6 CODE None RECALLING FIRM/MANUFACTURER Walthall County Co-op, Tylertown, MS, by telephone on June 26, 2006. Firm initiated recall is complete. REASON Possible contamination of dairy animal feeds with ruminant derived meat and bone meal. VOLUME OF PRODUCT IN COMMERCE 87 tons DISTRIBUTION MS ______________________________ PRODUCT Bulk custom dairy pre-mixes, Recall # V-120-6 CODE None RECALLING FIRM/MANUFACTURER Ware Milling Inc., Houston, MS, by telephone on June 23, 2006. Firm initiated recall is complete. REASON Possible contamination of dairy animal feeds with ruminant derived meat and bone meal. VOLUME OF PRODUCT IN COMMERCE 350 tons DISTRIBUTION AL and MS ______________________________ PRODUCT a) Tucker Milling, LLC Tm 32% Sinking Fish Grower, #2680-Pellet, 50 lb. bags, Recall # V-121-6; b) Tucker Milling, LLC #31120, Game Bird Breeder Pellet, 50 lb. bags, Recall # V-122-6; c) Tucker Milling, LLC #31232 Game Bird Grower, 50 lb. bags, Recall # V-123-6; d) Tucker Milling, LLC 31227-Crumble, Game Bird Starter, BMD Medicated, 50 lb bags, Recall # V-124-6; e) Tucker Milling, LLC #31120, Game Bird Breeder, 50 lb bags, Recall # V-125-6; f) Tucker Milling, LLC #30230, 30 % Turkey Starter, 50 lb bags, Recall # V-126-6; g) Tucker Milling, LLC #30116, TM Broiler Finisher, 50 lb bags, Recall # V-127-6 CODE All products manufactured from 02/01/2005 until 06/20/2006 RECALLING FIRM/MANUFACTURER Recalling Firm: Tucker Milling LLC, Guntersville, AL, by telephone and visit on June 20, 2006, and by letter on June 23, 2006. Manufacturer: H. J. Baker and Brothers Inc., Stamford, CT. Firm initiated recall is ongoing. REASON Poultry and fish feeds which were possibly contaminated with ruminant based protein were not labeled as "Do not feed to ruminants". VOLUME OF PRODUCT IN COMMERCE 7,541-50 lb bags DISTRIBUTION AL, GA, MS, and TN END OF ENFORCEMENT REPORT FOR AUGUST 9, 2006 ###
Subject: MAD COW FEED RECALL MI MAMMALIAN PROTEIN VOLUME OF PRODUCT IN COMMERCE 27,694,240 lbs Date: August 6, 2006 at 6:14 pm PST PRODUCT Bulk custom dairy feds manufactured from concentrates, Recall # V-113-6 CODE All dairy feeds produced between 2/1/05 and 6/16/06 and containing H. J. Baker recalled feed products. RECALLING FIRM/MANUFACTURER Vita Plus Corp., Gagetown, MI, by visit beginning on June 21, 2006. Firm initiated recall is complete. REASON The feed was manufactured from materials that may have been contaminated with mammalian protein. VOLUME OF PRODUCT IN COMMERCE 27,694,240 lbs DISTRIBUTION MI
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006 ###
Subject: MAD COW FEED RECALL AL AND FL VOLUME OF PRODUCT IN COMMERCE 125 TONS Products manufactured from 02/01/2005 until 06/06/2006 Date: August 6, 2006 at 6:16 pm PST PRODUCT a) CO-OP 32% Sinking Catfish, Recall # V-100-6; b) Performance Sheep Pell W/Decox/A/N, medicated, net wt. 50 lbs, Recall # V-101-6; c) Pro 40% Swine Conc Meal -- 50 lb, Recall # V-102-6; d) CO-OP 32% Sinking Catfish Food Medicated, Recall # V-103-6; e) "Big Jim's" BBB Deer Ration, Big Buck Blend, Recall # V-104-6; f) CO-OP 40% Hog Supplement Medicated Pelleted, Tylosin 100 grams/ton, 50 lb. bag, Recall # V-105-6; g) Pig Starter Pell II, 18% W/MCDX Medicated 282020, Carbadox -- 0.0055%, Recall # V-106-6; h) CO-OP STARTER-GROWER CRUMBLES, Complete Feed for Chickens from Hatch to 20 Weeks, Medicated, Bacitracin Methylene Disalicylate, 25 and 50 Lbs, Recall # V-107-6; i) CO-OP LAYING PELLETS, Complete Feed for Laying Chickens, Recall # 108-6; j) CO-OP LAYING CRUMBLES, Recall # V-109-6; k) CO-OP QUAIL FLIGHT CONDITIONER MEDICATED, net wt 50 Lbs, Recall # V-110-6; l) CO-OP QUAIL STARTER MEDICATED, Net Wt. 50 Lbs, Recall # V-111-6; m) CO-OP QUAIL GROWER MEDICATED, 50 Lbs, Recall # V-112-6 CODE Product manufactured from 02/01/2005 until 06/06/2006 RECALLING FIRM/MANUFACTURER Alabama Farmers Cooperative, Inc., Decatur, AL, by telephone, fax, email and visit on June 9, 2006. FDA initiated recall is complete. REASON Animal and fish feeds which were possibly contaminated with ruminant based protein not labeled as "Do not feed to ruminants". VOLUME OF PRODUCT IN COMMERCE 125 tons DISTRIBUTION AL and FL
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006 ###
Subject: MAD COW FEED RECALL KY VOLUME OF PRODUCT IN COMMERCE ????? Date: August 6, 2006 at 6:19 pm PST PRODUCT Bulk custom made dairy feed, Recall # V-114-6 CODE None RECALLING FIRM/MANUFACTURER Burkmann Feeds LLC, Glasgow, KY, by letter on July 14, 2006. Firm initiated recall is ongoing. REASON Custom made feeds contain ingredient called Pro-Lak, which may contain ruminant derived meat and bone meal. VOLUME OF PRODUCT IN COMMERCE ????? DISTRIBUTION KY END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006 ###
CJD WATCH MESSAGE BOARD TSS MAD COW FEED RECALL USA EQUALS 10,878.06 TONS NATIONWIDE Sun Jul 16, 2006 09:22 188.8.131.52
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II ______________________________ PRODUCT a) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals, Recall # V-079-6; b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg), Recall # V-080-6; c) PRO-PAK, MARINE & ANIMAL PROTEIN CONCENTRATE FOR USE IN ANIMAL FEED, Recall # V-081-6; d) Feather Meal, Recall # V-082-6 CODE a) Bulk b) None c) Bulk d) Bulk RECALLING FIRM/MANUFACTURER H. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 and by press release on June 16, 2006. Firm initiated recall is ongoing. REASON Possible contamination of animal feeds with ruminent derived meat and bone meal. VOLUME OF PRODUCT IN COMMERCE 10,878.06 tons DISTRIBUTION Nationwide END OF ENFORCEMENT REPORT FOR July 12, 2006 ###
Subject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006 Date: June 27, 2006 at 7:42 am PST Public Health Service Food and Drug Administration New Orleans District 297 Plus Park Blvd. Nashville, TN 37217 Telephone: 615-781-5380 Fax: 615-781-5391
May 17, 2006 WARNING LETTER NO. 2006-NOL-06 FEDERAL EXPRESS OVERNIGHT DELIVERY Mr. William Shirley, Jr., Owner Louisiana.DBA Riegel By-Products 2621 State Street Dallas, Texas 75204 Dear Mr. Shirley: On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration (FDA) investigator inspected your rendering plant, located at 509 Fortson Street, Shreveport, Louisiana. The inspection revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 [21 CFR 589.2000], Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). You failed to follow the requirements of this regulation; products being manufactured and distributed by your facility are misbranded within the meaning of Section 403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act (the Act). Our investigation found you failed to provide measures, including sufficient written procedures, to prevent commingling or cross-contamination and to maintain sufficient written procedures [21 CFR 589.2000(e)] because: You failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues into animal protein or feeds which may be used for ruminants. For example, your facility uses the same equipment to process mammalian and poultry tissues. However, you use only hot water to clean the cookers between processing tissues from each species. You do not clean the auger, hammer mill, grinder, and spouts after processing mammalian tissues. You failed to maintain written procedures specifying the clean-out procedures or other means to prevent carryover of protein derived from mammalian tissues into feeds which may be used for ruminants. As a result . the poultry meal you manufacture may contain protein derived from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR 589.2000(e)(1)(i), any products containing or may contain protein derived from mammalian tissues must be labeled, "Do not feed to cattle or other ruminants." Since you failed to label a product which may contain protein derived from mammalian tissues with the required cautionary statement. the poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the Act. This letter is not intended as an all-inclusive list of violations at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring your overall operation and the products you manufacture and distribute are in compliance with the law. You should take prompt action to correct these violations, and you should establish a system whereby violations do not recur. Failure to promptly correct these violations may result in regulatory action, such as seizure and/or injunction, without further notice. You should notify this office in writing within 15 working days of receiving this letter, outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating corrections have been made. Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S. Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie, Louisiana 70001. If you have questions regarding any issue in this letter, please contact Mr. Rivero at (504) 219-8818, extension 103. Sincerely, /S Carol S. Sanchez Acting District Director New Orleans District
look at the table and you'll see that as little as 1 mg (or 0.001 gm) caused 7% (1 of 14) of the cows to come down with BSE;
Risk of oral infection with bovine spongiform encephalopathy agent in primates
Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog, Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe Deslys
Summary The uncertain extent of human exposure to bovine spongiform encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease (vCJD)--is compounded by incomplete knowledge about the efficiency of oral infection and the magnitude of any bovine-to-human biological barrier to transmission. We therefore investigated oral transmission of BSE to non-human primates. We gave two macaques a 5 g oral dose of brain homogenate from a BSE-infected cow. One macaque developed vCJD-like neurological disease 60 months after exposure, whereas the other remained free of disease at 76 months. On the basis of these findings and data from other studies, we made a preliminary estimate of the food exposure risk for man, which provides additional assurance that existing public health measures can prevent transmission of BSE to man.
BSE bovine brain inoculum 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%) 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 used in our study with primates against a bovine brain inoculum with a similar PrPres concentration that was inoculated into mice and cattle.8 *Data are number of animals positive/number of animals surviving at the time of clinical onset of disease in the first positive animal (%). The accuracy of bioassays is generally judged to be about plus or minus 1 log. ic ip=intracerebral and intraperitoneal. Table 1: Comparison of transmission rates in primates and cattle infected orally with similar BSE brain inocula
Published online January 27, 2005
[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE)
[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
THE SEVEN SCIENTIST REPORT ***
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
still sadly disgusted,
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
Regeneration Technologies, Inc.
Terry S. Singeltary Sr.
P.O. Box 42
Baycliff, Texas USA 77518