Docket No. FDA– 2009–N–0505
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration [Docket No. FDA–2009–N–0505]
Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle
AGENCY: Food and Drug Administration, HHS. ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of existing FDA regulations concerning FDA-regulated human food, including dietary supplements, and cosmetics manufactured from, processed with, or otherwise containing material derived from cattle.
DATES: Submit either electronic or written comments on the collection of information by August 14, 2017.
ADDRESSES: You may submit comments as follows:
Electronic Submissions Submit electronic comments in the following way:
• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to
https:// www.regulations.gov
will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows:
• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’
Instructions: All submissions received must include the Docket No. FDA– 2009–N–0505 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle.’’
Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/2015- 23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, 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: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301– 796–7726.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:
(1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility;
(2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle—21 CFR 189.5 and 700.27 OMB Control Number 0910–0623— Extension
FDA’s regulations in §§ 189.5 and 700.27 (21 CFR 189.5 and 700.27) set forth bovine spongiform encephalopathy (BSE)-related restrictions applicable to FDA-regulated human food and cosmetics. The regulations designate certain materials from cattle as ‘‘prohibited cattle materials,’’ including specified risk materials (SRMs), the small intestine of cattle not otherwise excluded from being a prohibited cattle material, material from nonambulatory disabled cattle, and mechanically separated (MS) beef. Sections 189.5(c) and 700.27(c) set forth the requirements for recordkeeping and records access for FDA-regulated human food, including dietary supplements, and cosmetics manufactured from, processed with, or otherwise containing material derived from cattle. The FDA issued these recordkeeping regulations under the adulteration provisions in sections 402(a)(2)(C), (a)(3), (a)(4), (a)(5), 601(c), and 701(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 342(a)(2)(C), (a)(3), (a)(4), (a)(5), 361(c), and 371(a)). Under section 701(a) of the FD&C Act, the FDA is authorized to issue regulations for the FD&C Act’s efficient enforcement. With regard to records concerning imported human food and cosmetics, the FDA relied on its authority under sections 701(b) and 801(a) of the FD&C Act (21 U.S.C. 371(b) and 381(a)). Section 801(a) of the FD&C Act provides requirements with regard to imported human food and cosmetics and provides for refusal of admission of human food and cosmetics that appear to be adulterated into the United States. Section 701(b) of the FD&C Act authorizes the Secretaries of Treasury and Health and Human Services to jointly prescribe regulations for the efficient enforcement of section 801 of the FD&C Act.
These requirements are necessary because once materials are separated from an animal it may not be possible, without records, to know the following: (1) Whether cattle material may contain SRMs (brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae and the wings of the sacrum), and dorsal root ganglia from animals 30 months and older and tonsils and distal ileum of the small intestine from all animals of all ages); (2) whether the source animal for cattle material was inspected and passed; (3) whether the source animal for cattle material was nonambulatory disabled or MS beef; and (4) whether tallow in human food or cosmetics contain less than 0.15 percent insoluble impurities.
FDA’s regulations in §§ 189.5(c) and 700.27(c) require manufacturers and processors of human food and cosmetics manufactured from, processed with, or otherwise containing material from cattle establish and maintain records sufficient to demonstrate that the human food or cosmetics are not manufactured from, processed with, or otherwise contains prohibited cattle materials. These records must be retained for 2 years at the manufacturing or processing establishment or at a reasonably accessible location. Maintenance of electronic records is acceptable, and electronic records are considered to be reasonably accessible if they are accessible from an onsite location. Records required by these sections and existing records relevant to compliance with these sections must be available to FDA for inspection and copying. Existing records may be used if they contain all of the required information and are retained for the required time period.
Because FDA does not easily have access to records maintained at foreign establishments, FDA regulations in §§ 189.5(c)(6) and 700.27(c)(6), respectively, require that when filing for entry with U.S. Customs and Border Protection, the importer of record of human food or cosmetics manufactured from, processed with, or otherwise containing cattle material must affirm that the human food or cosmetics were manufactured from, processed with, or otherwise containing-cattle material and must affirm that the human food or cosmetics were manufactured in accordance with the applicable requirements of §§ 189.5 or 700.27. In addition, if human food or cosmetics were manufactured from, processed with, or otherwise containing-cattle material, the importer of record must provide within 5 business days records sufficient to demonstrate that the human food or cosmetics were not manufactured from, processed with, or otherwise contains prohibited cattle material, if requested.
Under FDA’s regulations, FDA may designate a country from which cattle materials inspected and passed for human consumption are not considered prohibited cattle materials, and their use does not render human food or cosmetics adulterated. Sections 189.5(e) and 700.27(e) provide that a country seeking to be designated must send a written request to the Director of the Center for Food Safety and Applied Nutrition (CFSAN Director). The information the country is required to submit includes information about a country’s BSE case history, risk factors, measures to prevent the introduction and transmission of BSE, and any other information relevant to determining whether SRMs, the small intestine of cattle not otherwise excluded from being a prohibited cattle material, material from nonambulatory disabled cattle, or MS beef from the country seeking designation should be considered prohibited cattle materials. FDA uses the information to determine whether to grant a request for designation and to impose conditions if a request is granted.
Sections 189.5 and 700.27 further state that countries designated under §§ 189.5(e) and 700.27(e) will be subject to future review by FDA to determine whether their designations remain appropriate. As part of this process, FDA may ask designated countries to confirm their BSE situation and the information submitted by them, in support of their original application, has remained unchanged. FDA may revoke a country’s designation if FDA determines that it is no longer appropriate. Therefore, designated countries may respond to periodic FDA requests by submitting information to confirm their designations remain appropriate. FDA uses the information to ensure their designations remain appropriate.
Description of Respondents: Respondents to this information collection include manufacturers, processors, and importers of FDA regulated human food, including dietary supplements, and cosmetics manufactured from, processed with, or otherwise containing material derived from cattle, as well as, with regard to §§ 189.5(e) and 700.27(e), foreign governments seeking designation under those regulations.
FDA estimates the burden of this collection of information as follows:
snip...
Except where otherwise noted, this estimate is based on FDA’s estimate of the number of facilities affected by the final rule entitled, ‘‘Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle’’ published in the Federal Register of October 11, 2006 (71 FR 59653). Reporting: FDA’s regulations in §§ 189.5(c)(6) and 700.27(c)(6) impose a reporting burden on importers of human food and cosmetics manufactured from, processed with, or otherwise containing cattle material. Importers of these products must affirm that the human food or cosmetics are not manufactured from, processed with, or otherwise contain prohibited cattle materials and must affirm that the human food or cosmetics were manufactured in accordance with the applicable requirements of §§ 189.5 or 700.27. The affirmation is made by the importer of record to the FDA through FDA’s Operational and Administrative System for Import Support. Affirmation by importers is expected to take approximately 2 minutes per entry line. Table 2 shows 54,825 lines of human food and cosmetics likely to contain cattle materials are imported annually. The reporting burden of affirming whether import entry lines contain cattle-derived materials is estimated to take 1,809 hours annually (54,825 lines × 2 minutes per line).
FDA’s estimate of the reporting burden for designation under §§ 189.5 and 700.27 is based on its experience and the average number of requests for designation received in the past 3 years. In the last 3 years, FDA has not received any requests for designation. Thus, FDA estimates that one or fewer will be received annually in the future. Based on this experience, FDA estimates the annual number of new requests for designation will be one. FDA estimates that preparing the information required by §§ 189.5 and 700.27 and submitting it to FDA in the form of a written request to the CFSAN Director will require a burden of approximately 80 hours per request. Thus, the burden for new requests for designation is estimated to be 80 hours annually, as shown in table 1, row 2.
Under §§ 189.5(e) and 700.27(e), designated countries are subject to future review by FDA and may respond to periodic FDA requests by submitting information to confirm their designations remain appropriate. In the last 3 years, FDA has not requested any reviews. Thus, FDA estimates that one or fewer will occur annually in the future. FDA estimates that the designated country undergoing a review in the future will need one-third of the time it took preparing its request for designation to respond to FDA’s request for review, or 26 hours (80 hours × 0.33 = 26.4 hours, rounded to 26). The annual burden for reviews is estimated to be 26 hours, as shown in table 1, row 3. The total reporting burden for this information collection is estimated to be 1,915 hours annually.
Recordkeeping: FDA estimates that there are 697 domestic facility relationships and 916 foreign facility relationships consisting of the following facilities: An input supplier of cattlederived materials that requires records (the upstream facility) and a purchaser of cattle-derived materials requiring documentation (this may be a human food or cosmetics manufacturer or processor). The recordkeeping burden of FDA’s regulations in §§ 189.5(c) and 700.27(c) is the burden of sending, verifying, and storing documents regarding shipments of cattle material that is to be used in human food and cosmetics.
In this estimate of the recordkeeping burden, FDA treats these recordkeeping activities as shared activities between the upstream and downstream facilities. It is in the best interests of both facilities in the relationship to share the burden necessary to comply with the regulations; therefore, FDA estimates the time burden of developing these records as a joint task between the two facilities. Thus, FDA estimates that this recordkeeping burden will be about 15 minutes per week, or 13 hours per year, and FDA assumes that the recordkeeping burden will be shared between 2 entities (i.e., the ingredient supplier and the manufacturer of finished products). Therefore, the total recordkeeping burden for domestic facilities is estimated to be 9,061 hours (13 hours × 697), and the total recordkeeping burden for foreign facilities is estimated to be 11,908 hours (13 hours × 916), as shown in table 2. Dated: June 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017–12448 Filed 6–14–17; 8:45 am] BILLING CODE 4164–01–P
Singeltary Comment Submission Docket No. FDA– 2009–N–0505 Agency Information Collection Activities; Proposed Collection; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle
Greetings FDA et al, i would kindly like to submit my comments and source references on Docket No. FDA– 2009–N–0505 Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle. Due to the continued spreading of the Transmissible Spongiform Encephalopathy TSE Prion disease aka mad cow type disease, i believe it is paramount that this information is collected, documented, and put into the public domain. IF we fail to do this, we fail the public, and these industry's will continue to blatantly disregard said regulations that are in place to protect public health from materials that may contain prohibited cattle materials [21 CFR 189.5(c)(1)]. These violations are still ongoing. atypical BSE spreading, CWD in cervid spreading, and scrapie cannot be halted, all of which have now been linked by sound science to humans as sporadic CJD and nvCJD. most disturbing is the recent studies from Prion 2017 Conference showing that CWD transmits to Macaque orally, and CWD transmits to PIGS orally. very disturbing, and even more disturbing is the huge loophole in the BSE ruminant feed ban that has failed from day one. this loophole must be closed immediately. to continue this charade, and to continue to allow these products to be consumed, with said prohibited cattle materials [21 CFR 189.5(c)(1)], and then NOT to allow the pubic access to this information, should be criminal in my opinion...
Thank You,
I am sincerely,
Terry S. Singeltary Sr.
please see ;
SOURCE REFERENCES
FDA DOES NOT have mandatory established specifications for animal-derived ingredients to ensure they are BSE free in Nutritional Supplements
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm562515.htm
http://creutzfeldt-jakob-disease.blogspot.com/2017/06/prion-2017-p20-descriptive-epidemiology.html
''We offer the following comments: 1. Records must be maintained that demonstrate-that products are not manufactured from, processed with, or does not otherwise contain prohibited cattle materials [21 CFR 189.5(c)(1)]. During the inspection it was determined your firm receives collagen derived from (b)(4) products or by-products; however, your firm was not able to provide any documentation to support the materials are free from bovine spongiform encephalopathy (BSE). Your firm also stated you do not have any established specifications for animal-derived ingredients to ensure they are BSE free.''
WARNING LETTER
CMS#521980
May 31, 2017
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Dr. Caesar DePaco, Owner
Summit Nutritionals International, Inc.
1250 Route 28, Suites 305B, 306 & 308
Branchburg, NJ 08876
Dear Dr. DePaco:
The U.S. Food and Drug Administration (FDA) inspected your facility located at 1555 Lyell Ave., Rochester, NY 14606-2145, on June 21, 23 and 27, 2016 and again on February 27, 2017 which operates a re-packer of bulk dietary ingredients for your parent frrm, Summit Nutritionals International, Inc., 29 Rockaway Road, Lebanon, NJ, 08833..
Our investigator collected receiving records and labeling for your product labeled as Hydrolyzed Salmon Collagen Powder 90% Protein. We have reviewed receiving records and labeling and found violations of the food labeling regulations, 21 CFR Part 101, that cause your product to be misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343]. You can find the Act and FDA’s regulations through links in FDA’s home page at www.fda.gov.
Your Hydrolyzed Salmon Collagen Powder 90% Protein product is misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the product label is false and misleading in any particular. Specifically, during the inspection your product was observed being repackaged and relabeled as Hydrolyzed Salmon Collagen Powder 90% Protein; however, the product is actually Hydrolyzed Gelatin sourced from (b)(4). Additionally, the manufacturer's label for the Hydrolyzed Gelatin product states that it is "MADE IN CHINA." Whereas the label for the Hydrolyzed Salmon Collagen Powder 90% Protein states that it is "Proudly Made in The USA" and the Certificate of Analysis states "Country of Origin: United States of America" which makes it appear that the country of origin labeling is also false and misleading. Food labeling statements regarding geographical origin must not be false or misleading in any particular. See Compliance Policy Guide (CPG) Sec. 560.200 Country of Origin Labeling for more information at https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074567.htm
We note that additional inspections of your parent firm, Summit Nutritionals International, Inc., 29 Rockaway Road, Lebanon, NJ, 08833 on October 26, 2015 through November 10, 2015 and again on August 15, 2016 through September 13, 2016 also indicated similar misbranding violations may be occurring with your porcine, bovine and/or chicken collagen products. We recommend that you review all of your product labels to be consistent with our policy to avoid additional misbranding of your food products.
This letter is not meant to be an all-inclusive list of the violations that exist at your firm or that exist in connection with your products. You are responsible for ensuring that your products are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations in this letter. Failure to promptly correct the violations may result in enforcement action without further notice, such as seizure or injunction.
We offer the following comments:
1. Records must be maintained that demonstrate-that products are not manufactured from, processed with, or does not otherwise contain prohibited cattle materials [21 CFR 189.5(c)(1)]. During the inspection it was determined your firm receives collagen derived from (b)(4) products or by-products; however, your firm was not able to provide any documentation to support the materials are free from bovine spongiform encephalopathy (BSE). Your firm also stated you do not have any established specifications for animal-derived ingredients to ensure they are BSE free.
2. The product label fails to declare the net quantity of contents as required by 21 CFR 101.7. For example, statements of weight shall be declared in terms of avoirdupois pound and ounce in accordance with 21 CFR 101.7(b)(1).
You should respond in writing within fifteen working days from your receipt of this letter outlining the specific steps that you have taken to correct these violations. You should include in your response documentation such as revised product labels and website information, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your response should be sent to the following address: U.S. Food and Drug Administration, 10 Waterview Blvd., 3rd Floor, Parsippany, New Jersey 07054. If you should have any questions regarding any issue in this letter, please contact Andrew Ciaccia, Compliance Officer.
Sincerely,
/S/
Evelyn Bonnin
Program Division Director
HAF Division 2 E
2017
Page Last Updated: 06/12/2017
2. Records must be maintained that demonstrate that products are not manufactured from, processed with, or does not otherwise contain prohibited cattle materials [21 CFR 189.5(c)(1)]. During the inspection your firm stated that the soft gel caps used for herbal oil products are derived from bovine products or by-products; however, your firm was not able to provide any documentation to support the materials are free from bovine spongiform encephalopathy (BSE). Your firm also stated you do not have any established specifications for animal-derived ingredients to ensure they are BSE free.
Seattle District Office
22215 26th Ave. SE, Ste. 210
Bothell, WA 98021
November 15, 2016
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
In reply refer to Warning Letter SEA 17-02
Raymond W. Szeto, President
NutriResearch, Inc.
704 West Meeker Street
Kent, Washington 98032-5758
WARNING LETTER
Dear Mr. Szeto:
The United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 704 West Meeker Street, Kent, Washington, on March 24, 25, and 29, 2016, and April 5 and 15, 2016. During the inspection we collected labeling for your products. Based on our inspection and subsequent review of your firm’s labeling, we found serious violations of the Federal Food, Drug and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov.
Unapproved New Drugs/Misbranded Drugs
The FDA reviewed your website at the Internet address www.biomedbalance.com in November 2016 and determined that you take orders there for the products Chaga, Eye Health, Hepatocel Plus, Reishi, Coriolus, Healthy Joint, Horny Goat Weed, and GlucoResistance. In addition, the FDA reviewed some of your product labels and your “BioMed Balance Beauty Naturally A Division of NutriResearch Inc pamphlet” that you include in product shipments to customers. The claims on your product labels and website and in your pamphlet establish that these products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
Examples of some of the claims that provide evidence that your products are intended for use as drugs include:
Chaga
Website:
“[B]een used . . . as a cleansing and disinfecting measures and as decoctions for stomach diseases, intestinal worms liver and heart ailments and cancer treatments . . . Chaga has demonstrated anti-HIV, antibacterial anti-malarial, anti-inflammatory and anthelmintic properties.”
Eye Health
Website:
“[S]upports eye conditions such as Cataract, Glaucoma, age related Macular Degeneration, dry eyes . . .”
Hepatocel Plus
Website:
“[D]eveloped to target Hepatitis C virus in three ways: first . . . it destroys HCV-RNA* and prevented HCV from replicating further; second, it modulates the immune system to produce antibodies against HCV and stimulate Macrophage, Natural Killer Cell, Neutrophil and T-Lymphocytes*, protects liver cells by lowering the serum glutamic pyruvate transaminase (SGPT) in patients with HCV, both SGOT and SGPT are used to monitor liver inflammation*, also . . . ability to reduce hepatocellular necrosis which, in turn, may delay or prevent the occurrence of hepatic (liver) failure*.”
Pamphlet:
“[D]estroys HCV-RNA* and prevented HCV from replicating further . . . modulates the immune system to produce antibodies against HCV and stimulate Macrophage, Natural Killer Cell, Neutrophil and T-Lymphocytes* . . . protects liver cells by lowering the serum glutamic pyruvate transaminase (SGPT) in patients with hepatic (liver) failure.”
Reishi
Pamphlet:
“Reishi has a cure rate as impressive as that treat [sic] by pharmacology . . . ability to treat numerous health problems, from high blood pressure to AIDS . . . Reishi eliminates cholesterol build-up . . . Reishi is a natural anticoagulant . . .”
“Testimony No. 2: Cold & Flu and the New Miracle Cure…abscess tooth . . . medicine helped reduce the swelling and pressure . . . our new miracle cure for everything.”
“Testimony No. 3: Bronchitis . . . ReishiGold after I took it. I got rid of my bronchitis in 2 days.”
“Testimony No. 5: Brain tumor shrink, healed toothache. . . ResishiGold . . . think helped his tumor shrink some per his CAT scans . . .”
“Testimony No. 10: Diabetes: After (take ReishiGold) one week need for insulin dropped 30% . . .”
Coriolus
Pamphlet:
“[I]n Japan and China, Coriolus is widely used as prescription medicines for treatment of cancer . . . anti-tumor effect have been reported . . . increase survival rates . . . proved to [sic] effective against tumor both in animal experiments and in clinical patients.”
Healthy Joint
Website:
“E]ffective for the treatment of arthritis pain, muscular spasm, nerve pain and ligament strain and sprain . . . effective as an analgesic, anti-inflammatory and sedative agent similar to nonsteroidal anti-inflammatory drugs (NSAIDS) in the treatment of arthritis . . . helps increase the release of dopamine level in the body and brain to act as a natural pain reliever . . . useful in the treatment of Rheuma- toid [sic] arthritis and Osteoarthritis. Collagen helps with the healing and repairing damaged bones and cartilages.”
Pamphlet:
“[E]ffective for the treatment of arthritis pain, muscular spasm, nerve pain and ligament strain and sprain . . . effective as an analgesic, anti-inflammatory and sedative agent similar to nonsteroidal anti-inflammatory drugs (NSAIDS) in the treatment of arthritis . . . helps increase the release of dopamine level in the body and brain to act as a natural pain reliever . . . useful in the treatment of Rheuma- toid [sic] arthritis and Osteoarthritis. Collagen helps with the healing and repairing damaged bones and cartilages.”
Horny Goat Weed
Pamphlet:
“[H]elp treat chronic bronchitis, Asthma, neurological and immunological inhitition [sic], cardio-cerebral vascular disease, cerebral asteriosclerosis and coronary heart disease . . . used to treat high blood pressure in elderly women, paralysis of the lower limbs. It has also use for depression . . .”
GlucoResistance
Pamphlet and website:
“[L]owers blood glucose . . . helps human insulin to become more sensitive for the uptake of glucose into the cells . . . improve cholesterol profiles, to combat obesity and hyperglycemia.”
Healthy Vision (Teresa Charities brand)
Product Label:
“Healthy Vision nutritional formula supports eye conditions such as Cataract, Glaucoma, Age-Related Macular Degeneration, dry eyes . . .”
The products listed above are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 321(d) and 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your products Chaga, Eye Health, Hepatocel Plus, Reishi, Coriolus, Horny Goat Weed, GlucoResistance, and Healthy Vision are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Chaga, Eye Health, Hepatocel Plus, Reishi, Coriolus, Horny Goat Weed, GlucoResistance, and Healthy Vision fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
Dietary Supplement CGMP Violations
Our investigators observed the following significant violations of FDA’s Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111), which render your Cordyceps Sinensis and Red Cordyceps Extract products adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)]. Additionally, even if your Healthy Vision product did not have therapeutic claims which make it an unapproved new drug and misbranded drug, Healthy Vision would be an adulterated dietary supplement under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] for the reasons described below.
The following observations were noted on the Form FDA 483, Inspectional Observations, issued to you on April 15, 2016. We received your response dated April 25, 2016, and have addressed relevant information from your response below.
You failed to establish and follow written procedures to fulfill the requirements relating to product complaints, as required by 21 CFR 111.553. Specifically, your firm has not established written procedures for the review and investigation of product complaints. Once you establish the required written procedures relating to product complaints, you must make and keep a written record of every product complaint that is related to good manufacturing practice, in accordance with 21 CFR 111.570(b)(2).
We have reviewed your response letter dated April 25, 2016, and find your response to be inadequate because the written procedure you provided fails to establish written procedures that fulfill the requirements applicable to the review and investigation of product complaints. Specifically, your written procedure fails to designate a qualified person to review all product complaints to determine whether the product complaint involves a possible failure of a dietary supplement to meet any of its specifications, and your procedure does not require that quality control personnel must review and approve decisions about whether to investigate a product complaint, in accordance with 21 CFR 111.560.
You failed to establish the required specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (MMR), as required by 21 CFR 111.70(a). You do not have written specifications to ensure the consistent production of your finished dietary supplements. Specifically, for your Healthy Vision, Lot # 5120, Cordyceps Sinensis, Lot # 7177, and/or Red Cordyceps Extract Lot # 6204 and 6205 products:
a. You failed to establish the following required component specifications for each component that you use in the manufacture of a dietary supplement:
i. Identity specifications [21 CFR 111.70(b)(1)];
ii. Component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met [21 CFR 111.70(b)(2)]; and
iii. Limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement [21 CFR 111.70(b)(3)].
b. You failed to establish in-process specifications for any point, step, or stage in the MMR where control is necessary to help ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplements and, as necessary, for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.70(c)(1).
c. You failed to establish specifications for dietary supplement labels (label specifications) and for packaging that may come in contact with dietary supplements (packaging specifications), as required by 21 CFR 111.70(d).
d. You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e).
Once you have established the required specifications, you must verify that the specifications are met, in accordance with 21 CFR 111.73.
We have reviewed your response letter dated April 25, 2016. We are unable to evaluate the adequacy of your corrective action because you failed to provide specific information to demonstrate that you have established the required specifications, as identified in 21 CFR 111.70.
You failed to prepare and follow a written MMR for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). For example, during the inspection, the investigators observed that you had not prepared MMRs for the following dietary supplements:
a. Healthy Vision, Lot # 5120
b. Cordyceps Sinensis, Lot # 7177
c. Red Cordyceps Extract, Lot # 6204 and 6205
We have reviewed your response letter dated April 25, 2016, but we are unable to evaluate the adequacy of your corrective action because the information you provided does not demonstrate that you have prepared MMRs for your Healthy Vision and Red Cordyceps Extract products that satisfy the requirements of 21 CFR 111.205(a). Additionally, while it appears that you attached a document titled Exhibit A for the purpose of demonstrating the MMR you intend to use for your Cordyceps Sinensis product, this document is inadequate for use as an MMR because it does not contain the following information, as required by 21 CFR 111.210. Specifically, it fails to contain:
a. A complete list of components to be used [21 CFR 111.210(b)];
b. An accurate statement of the weight or measure of each component to be used [21 CFR 111.210(c)];
c. A statement of any intentional overage amount of a dietary ingredient [21 CFR 111.210(e)];
d. A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made [21 CFR 111.210(f)];
e. A description of packaging [21 CFR 111.210(g)]; and
f. Written instructions of specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled, as specified in the MMR [21 CFR 111.210(h)(1)].
4. You failed to prepare a batch production record (BPR) every time you manufactured a batch of dietary supplement, as required by 21 CFR 111.255(a). Specifically, you do not prepare a BPR as part of your production process.
We have reviewed your response letter dated April 25, 2016, but we are unable to evaluate the adequacy of your corrective action. In your response you provided a document titled Exhibit A for the purpose of demonstrating the MMR you intend to use to comply with MMR requirements, and your response asserts that the same document will be used “to comply the batch production record every time we manufactured a batch of dietary supplement.”However, the document provided does not include all information required as part of a BPR. Example of some of the missing information includes the identity of equipment and processing lines used in producing the batch; the date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in the production of the batch; the unique identifier that you assign to each component; and the identity and weight or measure of each components used (21 CFR 111.260).
You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any processing, as required by 21 CFR 111.103. Specifically, you have not established any quality control procedures.
Once you have established your written quality control procedures, you must implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.65.
We have reviewed your response letter dated April 25, 2016, but we are unable to evaluate the adequacy of your corrective action. Your response asserts that you have established written procedures for quality control to meet the identity, purity, strength, and composition of the finished products, but the documentation you provided with your response does not include written procedures for quality control operations that include actions for conducting a material review, making a disposition decision, and approving or rejecting any reprocessing.
You failed to establish and follow written procedures for returned dietary supplements, as required by 21 CFR 111.503. Specifically, you do not have written procedures for returned dietary supplements. During our inspection, our investigators observed returned products that were held in a small room at the back of your processing facility. These dietary supplements were not clearly identified as returned products and were not held or tagged to preclude redistribution. The investigators observed one box containing 36 bottles of unlabeled dietary supplements, along with returned boxes of dietary supplements with 2018 and 2019 expiration dates.
We have reviewed your response letter dated April 25, 2016, but we are unable to evaluate the adequacy of your corrective action. Your response states that you have established written procedures for certain situations in which dietary supplements are returned, but your response does not provide written procedures establishing the storage, tracking, and disposition of returned product. In addition, you did not advise what, if anything, you have done with the returned products our investigators observed during the inspection.
You failed to establish and follow written procedures for fulfilling the requirement for equipment and utensils, including written procedures for calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.25(a). Specifically, you have not established a written accuracy check or calibration procedure for your floor and desktop scales.
We have reviewed your response letter dated April 25, 2016, but we are unable to evaluate the adequacy of your corrective action. Your response stated that you have established written procedures for calibrating floor and desktop weighing scales, but you provided no documentation to demonstrate whether and how such procedures have been established.
You failed to use equipment and utensils that are of appropriate design, construction, and workmanship to ensure them to be suitable for their intended use and to be adequately cleaned and properly maintained, as required by 21 CFR 111.27(a). Specifically, we observed white labels covering various holes of the capsule counting machine. These labels are moved depending on the desired number of capsules per bottle and appear to leave a residue behind after they are removed. We observed this machine being utilized in counting “Healthy Vision” capsules on March 24 and 25, 2016, prior to bottling.
You failed to establish and follow written procedures for packaging and labeling operations, as required by 21 CFR 111.403. Specifically, you have not established written procedures for labeling operations, and the labeling operations observed during the inspection identified significant discrepancies between your formula worksheet and the product label for your Healthy Vision, Cordyceps Sinensis, and Red Cordyceps Extract.
Once you have established the required procedures, you must establish, before packaging and labeling, packaging and labels for each batch of dietary supplement to determine whether the packaging and labels conform to the MMR, as required by 21 CFR 111.410(c).
Adulterated Dietary Supplement
Additionally, even if your Healthy Vision product did not have therapeutic claims which make it an unapproved new drug and misbranded drug, the product would be adulterated under section 402(c) of the Act [21 U.S.C. § 342(c)] because the product bears or contains color additives which are unsafe within the meaning of section 721(a) of the Act [21 U.S.C. § 379(a)]. Subject to limited exceptions, section 721(a) deems a color additive to be unsafe unless its use is in conformity with the color additive's listing regulation. Specifically, your Healthy Vision product declares Astaxanthin and Anthocyanins on the product label, which are not approved for use as color additives as they are used in this product.
Misbranded Dietary Supplements
Your Healthy Vision, Cordyceps Sinensis, and Red Cordyceps Extract products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the labels fail to list the name and place of business of the manufacturer, packer, or distributor. Specifically, the statement of the place of business fails to include the city for the Red Cordyceps Extract product and the zip code for all three products, in accordance with 21 CFR 101.5(d).
Your Healthy Vision, Cordyceps Sinensis and Red Cordyceps Extract products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] in that the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). For example,
a. Your Healthy Vision product label fails to include the part of the plant from which Sabucus Nigra Extract is derived.
b. Your Cordyceps Sinensis and Red Cordyceps Extract product labels fail to include the part of the plant from which the cordyceps sinensis extract is derived.
Your Cordyceps Sinensis and Red Cordyceps Extract products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. For example,
a. The Cordyceps Sinensis and Red Cordyceps Extract product labels declare “Polysaccharide” and “Polysaccharides”, respectively, but fail to list the name of the individual Polysaccharide(s).
b. The Red Cordyceps Extract product label declares “S.B. Extract” but fails to list the common or usual name of this ingredient.
c. The Cordyceps Sinensis and Health Vision product labels indicate vegetarian capsules. However, the labels fail to declare the capsule ingredients.
4. Your Red Cordyceps Extract product is misbranded within the meaning of sections 403(s)(2)(A)(ii)(I) and 403(q)(5)(F) of the Act [21 U.S.C. §§ 343 (s)(2)(A)(ii)(I) and 343(q)(5)(F)] in that it fails to include the quantitative amount by weight per serving size of all the dietary ingredients as required by 21 CFR 101.36. Specifically, the product label fails to include the quantitative amount by weight of Standardized Polysaccharides; as noted previously, this ingredient must be listed by the common or usual name. We also note that if the “Standardized Polysaccharides” constituents of the Cordyceps Sinensis Extract product, then the common or usual name of the “Standardized Polysaccharides” should be indented under “Cordyceps Sinensis Extract” with the quantitative amount per serving.
Your Healthy Vision product is misbranded within the meaning of section 403(q)(5)(F) of the Act [U.S.C. § 343(q)(5)(F)] in that the label fails to declare Vitamin C in accordance with 21 CFR 101.36(c)(1). This dietary ingredient contained in the proprietary blend must be declared in accordance with 21 CFR 101.36(b)(2) and dietary ingredients contained in the proprietary blend that are listed under 21 CFR 101.36(b)(3) are to be indented under the term “Proprietary Blend” and listed under the column of names described in 21 CFR 101.36(b)(2)(i)(B).
Your Healthy Vision and Cordyceps Sinensis products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the labels do not include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).
Your Red Cordyceps Extract dietary supplement product is misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)], in that the label fails to include a domestic address or domestic phone number through which the responsible person, as described in section 761(b) of the Act [21 U.S.C §379AA-1], may receive a report of a serious adverse event with such dietary supplement.
This letter is not intended to be an all-inclusive list of the violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with the Act and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations and implement lasting corrective action of these violations may result in regulatory action without further notice, including, without limitation, seizure and injunction.
We offer the following comments:
1. Any expiration date, shelf life, or “Best by” date you place on a product label should be supported by stability data [72 Fed. Reg. 34752, 34856 (Jun. 25, 2007)]. The term “shelf life dating” includes expiration dating and “best if used by” dating [72 Fed. Reg. 34752, 34912 (Jun. 25, 2007)]. You informed our investigator that you use expiration dates on your finished product labels; however, you did not have stability testing data to support this date.
2. Records must be maintained that demonstrate that products are not manufactured from, processed with, or does not otherwise contain prohibited cattle materials [21 CFR 189.5(c)(1)]. During the inspection your firm stated that the soft gel caps used for herbal oil products are derived from bovine products or by-products; however, your firm was not able to provide any documentation to support the materials are free from bovine spongiform encephalopathy (BSE). Your firm also stated you do not have any established specifications for animal-derived ingredients to ensure they are BSE free.
Please notify this office in writing within fifteen business days from the date you receive this letter describing the specific steps you have taken to correct the noted violations and to prevent these violations, or other similar violations, from occurring again. You should include documentation of corrective actions you have taken to date. If your firm’s planned corrections will occur over time, please state the reason for the delay and include a timetable for implementation of those corrections.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Your reply should be sent to: U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Patricia A. Pinkerton, Compliance Officer. Refer to the identification number WL SEA 17-02 when replying. If you have any questions regarding any issues in this letter, please contact Compliance Officer Patricia Pinkerton by telephone at 425-302-0428.
Sincerely,
/S/
Miriam R. Burbach
District Director
cc: Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560
*** unbelievable, absolutely unbelievable that this is still going on in 2017. please remember, some 300,000 cattle in the UK died from mad cow disease due to nothing more than a crude nutritional supplement called CATTLE FEED. ...terry
Research Project: TRANSMISSION, DIFFERENTIATION, AND PATHOBIOLOGY OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES
Location: Virus and Prion Research
Title: Disease-associated prion protein detected in lymphoid tissues from pigs challenged with the agent of chronic wasting disease
Author item Moore, Sarah item Kunkle, Robert item Kondru, Naveen item Manne, Sireesha item Smith, Jodi item Kanthasamy, Anumantha item West Greenlee, M item Greenlee, Justin
Submitted to: Prion Publication Type: Abstract Only Publication Acceptance Date: 3/15/2017 Publication Date: N/A Citation: N/A Interpretive Summary:
Technical Abstract: Aims: Chronic wasting disease (CWD) is a naturally-occurring, fatal neurodegenerative disease of cervids. We previously demonstrated that disease-associated prion protein (PrPSc) can be detected in the brain and retina from pigs challenged intracranially or orally with the CWD agent. In that study, neurological signs consistent with prion disease were observed only in one pig: an intracranially challenged pig that was euthanized at 64 months post-challenge. The purpose of this study was to use an antigen-capture immunoassay (EIA) and real-time quaking-induced conversion (QuIC) to determine whether PrPSc is present in lymphoid tissues from pigs challenged with the CWD agent.
Methods: At two months of age, crossbred pigs were challenged by the intracranial route (n=20), oral route (n=19), or were left unchallenged (n=9). At approximately 6 months of age, the time at which commercial pigs reach market weight, half of the pigs in each group were culled (<6 challenge="" groups="" month="" pigs="" remaining="" the="">6 month challenge groups) were allowed to incubate for up to 73 months post challenge (mpc). The retropharyngeal lymph node (RPLN) was screened for the presence of PrPSc by EIA and immunohistochemistry (IHC). The RPLN, palatine tonsil, and mesenteric lymph node (MLN) from 6-7 pigs per challenge group were also tested using EIA and QuIC.
Results: PrPSc was not detected by EIA and IHC in any RPLNs. All tonsils and MLNs were negative by IHC, though the MLN from one pig in the oral <6 5="" 6="" at="" by="" detected="" eia.="" examined="" group="" in="" intracranial="" least="" lymphoid="" month="" months="" of="" one="" pigs="" positive="" prpsc="" quic="" the="" tissues="" was="">6 months group, 5/6 pigs in the oral <6 4="" and="" group="" months="" oral="">6 months group. Overall, the MLN was positive in 14/19 (74%) of samples examined, the RPLN in 8/18 (44%), and the tonsil in 10/25 (40%). Conclusions:
This study demonstrates that PrPSc accumulates in lymphoid tissues from pigs challenged intracranially or orally with the CWD agent, and can be detected as early as 4 months after challenge.
CWD-infected pigs rarely develop clinical disease and if they do, they do so after a long incubation period. This raises the possibility that CWD-infected pigs could shed prions into their environment long before they develop clinical disease.
Furthermore, lymphoid tissues from CWD-infected pigs could present a potential source of CWD infectivity in the animal and human food chains.
CONFIDENTIAL
EXPERIMENTAL PORCINE SPONGIFORM ENCEPHALOPATHY
While this clearly is a cause for concern we should not jump to the conclusion that this means that pigs will necessarily be infected by bone and meat meal fed by the oral route as is the case with cattle. ...
we cannot rule out the possibility that unrecognised subclinical spongiform encephalopathy could be present in British pigs though there is no evidence for this: only with parenteral/implantable pharmaceuticals/devices is the theoretical risk to humans of sufficient concern to consider any action.
Our records show that while some use is made of porcine materials in medicinal products, the only products which would appear to be in a hypothetically ''higher risk'' area are the adrenocorticotrophic hormone for which the source material comes from outside the United Kingdom, namely America China Sweden France and Germany. The products are manufactured by Ferring and Armour. A further product, ''Zenoderm Corium implant'' manufactured by Ethicon, makes use of porcine skin - which is not considered to be a ''high risk'' tissue, but one of its uses is described in the data sheet as ''in dural replacement''. This product is sourced from the United Kingdom.....
snip...see much more here ;
WEDNESDAY, APRIL 05, 2017
Disease-associated prion protein detected in lymphoid tissues from pigs challenged with the agent of chronic wasting disease
TUESDAY, APRIL 18, 2017
*** EXTREME USA FDA PART 589 TSE PRION FEED LOOP HOLE STILL EXIST, AND PRICE OF POKER GOES UP ***
SPONTANEOUS ATYPICAL BOVINE SPONGIFORM ENCEPHALOPATHY
***Moreover, sporadic disease has never been observed in breeding colonies or primate research laboratories, most notably among hundreds of animals over several decades of study at the National Institutes of Health25, and in nearly twenty older animals continuously housed in our own facility.***
Saturday, April 23, 2016
PRION 2016 TOKYO Saturday, April 23, 2016
SCRAPIE WS-01: Prion diseases in animals and zoonotic potential 2016 Prion. 10:S15-S21. 2016 ISSN: 1933-6896 printl 1933-690X online Taylor & Francis Prion 2016 Animal Prion Disease Workshop
Abstracts
WS-01: Prion diseases in animals and zoonotic potential
Juan Maria Torres a, Olivier Andreoletti b, J uan-Carlos Espinosa a. Vincent Beringue c. Patricia Aguilar a, Natalia Fernandez-Borges a. and Alba Marin-Moreno a "Centro de Investigacion en Sanidad Animal ( CISA-INIA ). Valdeolmos, Madrid. Spain; b UMR INRA -ENVT 1225 Interactions Holes Agents Pathogenes. ENVT. Toulouse. France: "UR892. Virologie lmmunologie MolécuIaires, Jouy-en-Josas. France
Dietary exposure to bovine spongiform encephalopathy (BSE) contaminated bovine tissues is considered as the origin of variant Creutzfeldt Jakob (vCJD) disease in human. To date, BSE agent is the only recognized zoonotic prion. Despite the variety of Transmissible Spongiform Encephalopathy (TSE) agents that have been circulating for centuries in farmed ruminants there is no apparent epidemiological link between exposure to ruminant products and the occurrence of other form of TSE in human like sporadic Creutzfeldt Jakob Disease (sCJD). However, the zoonotic potential of the diversity of circulating TSE agents has never been systematically assessed. The major issue in experimental assessment of TSEs zoonotic potential lies in the modeling of the ‘species barrier‘, the biological phenomenon that limits TSE agents’ propagation from a species to another. In the last decade, mice genetically engineered to express normal forms of the human prion protein has proved essential in studying human prions pathogenesis and modeling the capacity of TSEs to cross the human species barrier. To assess the zoonotic potential of prions circulating in farmed ruminants, we study their transmission ability in transgenic mice expressing human PrPC (HuPrP-Tg). Two lines of mice expressing different forms of the human PrPC (129Met or 129Val) are used to determine the role of the Met129Val dimorphism in susceptibility/resistance to the different agents. These transmission experiments confirm the ability of BSE prions to propagate in 129M- HuPrP-Tg mice and demonstrate that Met129 homozygotes may be susceptible to BSE in sheep or goat to a greater degree than the BSE agent in cattle and that these agents can convey molecular properties and neuropathological indistinguishable from vCJD. However homozygous 129V mice are resistant to all tested BSE derived prions independently of the originating species suggesting a higher transmission barrier for 129V-PrP variant. Transmission data also revealed that several scrapie prions propagate in HuPrP-Tg mice with efficiency comparable to that of cattle BSE. While the efficiency of transmission at primary passage was low, subsequent passages resulted in a highly virulent prion disease in both Met129 and Val129 mice. Transmission of the different scrapie isolates in these mice leads to the emergence of prion strain phenotypes that showed similar characteristics to those displayed by MM1 or VV2 sCJD prion.
***These results demonstrate that scrapie prions have a zoonotic potential and raise new questions about the possible link between animal and human prions.
Title: Transmission of scrapie prions to primate after an extended silent incubation period) ***
In complement to the recent demonstration that humanized mice are susceptible to scrapie, we report here the first observation of direct transmission of a natural classical scrapie isolate to a macaque after a 10-year incubation period. Neuropathologic examination revealed all of the features of a prion disease: spongiform change, neuronal loss, and accumulation of PrPres throughout the CNS.
*** This observation strengthens the questioning of the harmlessness of scrapie to humans, at a time when protective measures for human and animal health are being dismantled and reduced as c-BSE is considered controlled and being eradicated.
*** Our results underscore the importance of precautionary and protective measures and the necessity for long-term experimental transmission studies to assess the zoonotic potential of other animal prion strains.
SCRAPIE WS-01: Prion diseases in animals and zoonotic potential 2016
Prion. 10:S15-S21. 2016 ISSN: 1933-6896 printl 1933-690X online
O.05: Transmission of prions to primates after extended silent incubation periods: Implications for BSE and scrapie risk assessment in human populations
Emmanuel Comoy, Jacqueline Mikol, Valerie Durand, Sophie Luccantoni, Evelyne Correia, Nathalie Lescoutra, Capucine Dehen, and Jean-Philippe Deslys Atomic Energy Commission; Fontenay-aux-Roses, France
Prion diseases (PD) are the unique neurodegenerative proteinopathies reputed to be transmissible under field conditions since decades. The transmission of Bovine Spongiform Encephalopathy (BSE) to humans evidenced that an animal PD might be zoonotic under appropriate conditions. Contrarily, in the absence of obvious (epidemiological or experimental) elements supporting a transmission or genetic predispositions, PD, like the other proteinopathies, are reputed to occur spontaneously (atpical animal prion strains, sporadic CJD summing 80% of human prion cases). Non-human primate models provided the first evidences supporting the transmissibiity of human prion strains and the zoonotic potential of BSE. Among them, cynomolgus macaques brought major information for BSE risk assessment for human health (Chen, 2014), according to their phylogenetic proximity to humans and extended lifetime. We used this model to assess the zoonotic potential of other animal PD from bovine, ovine and cervid origins even after very long silent incubation periods.
*** We recently observed the direct transmission of a natural classical scrapie isolate to macaque after a 10-year silent incubation period,
***with features similar to some reported for human cases of sporadic CJD, albeit requiring fourfold long incubation than BSE. Scrapie, as recently evoked in humanized mice (Cassard, 2014),
***is the third potentially zoonotic PD (with BSE and L-type BSE),
***thus questioning the origin of human sporadic cases. We will present an updated panorama of our different transmission studies and discuss the implications of such extended incubation periods on risk assessment of animal PD for human health.
===============
***thus questioning the origin of human sporadic cases***
***our findings suggest that possible transmission risk of H-type BSE to sheep and human. Bioassay will be required to determine whether the PMCA products are infectious to these animals.
LOOKING FOR CWD IN HUMANS AS nvCJD or as an ATYPICAL CJD, LOOKING IN ALL THE WRONG PLACES $$$
*** These results would seem to suggest that CWD does indeed have zoonotic potential, at least as judged by the compatibility of CWD prions and their human PrPC target. Furthermore, extrapolation from this simple in vitro assay suggests that if zoonotic CWD occurred, it would most likely effect those of the PRNP codon 129-MM genotype and that the PrPres type would be similar to that found in the most common subtype of sCJD (MM1).***
*** The potential impact of prion diseases on human health was greatly magnified by the recognition that interspecies transfer of BSE to humans by beef ingestion resulted in vCJD. While changes in animal feed constituents and slaughter practices appear to have curtailed vCJD, there is concern that CWD of free-ranging deer and elk in the U.S. might also cross the species barrier. Thus, consuming venison could be a source of human prion disease. Whether BSE and CWD represent interspecies scrapie transfer or are newly arisen prion diseases is unknown. Therefore, the possibility of transmission of prion disease through other food animals cannot be ruled out. There is evidence that vCJD can be transmitted through blood transfusion. There is likely a pool of unknown size of asymptomatic individuals infected with vCJD, ***
*** and there may be asymptomatic individuals infected with the CWD equivalent.
*** These circumstances represent a potential threat to blood, blood products, and plasma supplies.
SCRAPIE WS-01: Prion diseases in animals and zoonotic potential 2016
Prion. 10:S15-S21. 2016 ISSN: 1933-6896 printl 1933-690X online
why do we not want to do TSE transmission studies on chimpanzees $
5. A positive result from a chimpanzee challenged severly would likely create alarm in some circles even if the result could not be interpreted for man. I have a view that all these agents could be transmitted provided a large enough dose by appropriate routes was given and the animals kept long enough. Until the mechanisms of the species barrier are more clearly understood it might be best to retain that hypothesis.
snip...
R. BRADLEY
Subject: PRION 2017 CONFERENCE ABSTRACT First evidence of intracranial and peroral transmission of Chronic Wasting Disease (CWD) into Cynomolgus macaques: a work in progress
First evidence of intracranial and peroral transmission of Chronic Wasting Disease (CWD) into Cynomolgus macaques: a work in progress
There is some evidence that risk of CJD INCREASES WITH INCREASING FREQUENCY OF LAMB EATING (p = 0.02).
The evidence for such an association between beef eating and CJD is weaker (p = 0.14). When only controls for whom a relative was interviewed are included, this evidence becomes a little STRONGER (p = 0.08).
snip...
It was found that when veal was included in the model with another exposure, the association between veal and CJD remained statistically significant (p = < 0.05 for all exposures), while the other exposures ceased to be statistically significant (p = > 0.05).
snip...
In conclusion, an analysis of dietary histories revealed statistical associations between various meats/animal products and INCREASED RISK OF CJD. When some account was taken of possible confounding, the association between VEAL EATING AND RISK OF CJD EMERGED AS THE STRONGEST OF THESE ASSOCIATIONS STATISTICALLY. ...
snip...
In the study in the USA, a range of foodstuffs were associated with an increased risk of CJD, including liver consumption which was associated with an apparent SIX-FOLD INCREASE IN THE RISK OF CJD. By comparing the data from 3 studies in relation to this particular dietary factor, the risk of liver consumption became non-significant with an odds ratio of 1.2 (PERSONAL COMMUNICATION, PROFESSOR A. HOFMAN. ERASMUS UNIVERSITY, ROTTERDAM). (???...TSS)
snip...see full report ;
http://collections.europarchive.org/tna/20090505194948/http://bseinquiry.gov.uk/files/yb/1994/08/00004001.pdf
you can see more evidence here ;
http://chronic-wasting-disease.blogspot.com/2016/05/zoonotic-potential-of-cwd-prions-update.html
Stefanie Czub1, Walter Schulz-Schaeffer2, Christiane Stahl-Hennig3, Michael Beekes4, Hermann Schaetzl5 and Dirk Motzkus6 1
University of Calgary Faculty of Veterinary Medicine/Canadian Food Inspection Agency; 2Universitatsklinikum des Saarlandes und Medizinische Fakultat der Universitat des Saarlandes; 3 Deutsches Primaten Zentrum/Goettingen; 4 Robert-Koch-Institut Berlin; 5 University of Calgary Faculty of Veterinary Medicine; 6 presently: Boehringer Ingelheim Veterinary Research Center; previously: Deutsches Primaten Zentrum/Goettingen
This is a progress report of a project which started in 2009. 21 cynomolgus macaques were challenged with characterized CWD material from white-tailed deer (WTD) or elk by intracerebral (ic), oral, and skin exposure routes. Additional blood transfusion experiments are supposed to assess the CWD contamination risk of human blood product. Challenge materials originated from symptomatic cervids for ic, skin scarification and partially per oral routes (WTD brain). Challenge material for feeding of muscle derived from preclinical WTD and from preclinical macaques for blood transfusion experiments. We have confirmed that the CWD challenge material contained at least two different CWD agents (brain material) as well as CWD prions in muscle-associated nerves.
Here we present first data on a group of animals either challenged ic with steel wires or per orally and sacrificed with incubation times ranging from 4.5 to 6.9 years at postmortem. Three animals displayed signs of mild clinical disease, including anxiety, apathy, ataxia and/or tremor. In four animals wasting was observed, two of those had confirmed diabetes. All animals have variable signs of prion neuropathology in spinal cords and brains and by supersensitive IHC, reaction was detected in spinal cord segments of all animals. Protein misfolding cyclic amplification (PMCA), real-time quaking-induced conversion (RT-QuiC) and PET-blot assays to further substantiate these findings are on the way, as well as bioassays in bank voles and transgenic mice.
At present, a total of 10 animals are sacrificed and read-outs are ongoing. Preclinical incubation of the remaining macaques covers a range from 6.4 to 7.10 years. Based on the species barrier and an incubation time of > 5 years for BSE in macaques and about 10 years for scrapie in macaques, we expected an onset of clinical disease beyond 6 years post inoculation.
PRION 2017 DECIPHERING NEURODEGENERATIVE DISORDERS
Chronic Wasting Disease CWD TSE Prion to Humans, who makes that final call, when, or, has it already happened?
IF human transmission studies are unethical and will never take place, how much evidence is enough, and how much exposure do we allow, before a call is made.
HOW many humans do we expose before enough is enough?
How many body bags now are enough, for a very long incubating disease that the body bags will for sure mount later, if something is NOT finally done NOW.
the public must know.
Now, i will tell you all how this will be interpreted by our fine federal friends, and their lobbyist et al from corporate America, and Doctors there from, here is how this will still read, rubber stamped ;
''There is no direct evidence that CWD can transmit to humans, and CWD has never been identified in humans anywhere in the world, including in areas where CWD has been present in animal populations for decades.''
this is absurd, and fake news at it's finest.
what is 'direct evidence', if human transmission is not possible?
there is more than enough evidence to make that call now.
with that, who will finally make that judgement call, knowing that if cwd transmits to humans, it will look like the most common human tse prion i.e. sporadic cjd?
who makes that final call, when, and how many more humans must die before that decision is made and put in the public domain so we can go on with this and try to implement rules and regulations that might finally turn the tide, or do just let corporate science run rampant?
or, will they continue to run with the infamous UKBSEnvCJD only theory$
with cwd now being documented to transmit macaque, AND TO PIGS orally (lot of human medicine made from pigs), the price of continuing to play TSE Prion Poker with humans goes up drastically.
This is criminal negligence now, imo...terry
*** Subject: CWD TRANSMITS TO MACAQUE ORALLY MUSCLE INTAKE ***
Notice to Members Regarding Chronic Wasting Disease (CWD)
Posted on: May 31st, 2017
To: MNA Members From: Métis Nation of Alberta
Date: Wednesday, May 31, 2017
*** Métis Nation of Alberta (MNA) was made aware of a recent Canadian research study examining the transmission of Chronic Wasting Disease. The initial results of the study indicate that macaque monkeys (genetically similar to humans) can be infected with Chronic Wasting Disease (CWD) after eating deer that is infected with CWD. CWD is a prion disease, which are fatal, transmissible diseases characterized by abnormal proteins in the brain and nervous system. To date no research has shown that CWD can be passed on to humans, and no human cases of CWD have ever been identified. However, this new research indicates that it is a possibility. The Deputy Chief Medical Officer of Health has reached out to us to share with our Métis harvesters this important information. For more information you can visit:
Chronic Wasting Disease: CFIA Research Summary
Embargoed until May 23, 2017
(OCR of a scanned original)
Research Findings
Chronic Wasting Disease (CWD) is a progressive, fatal disease of the nervous system of cervids including deer, elk, moose, and reindeer that is caused by abnormal proteins called prions. It is known as a transmissible spongiform encephalopathy (TSE). Other TSEs include scrapie in sheep, bovine spongiform encephalopathy (BSE) in cattle, and Creutzfeldt-Jakob disease (CJD) in humans.
A limited number of experimental studies have demonstrated that non-human primates, specifically squirrel monkeys, are susceptible to CWD prions. An ongoing research study has now shown that CWD can also be transmitted to macaques, which are genetically closer to humans.
The study led by Dr. Stefanie Czub, a scientist at the Canadian Food Inspection Agency (CFIA), and funded by the Alberta Prion Research institute has demonstrated that by orally administering material under experimental conditions from cervids (deer and elk) naturally infected with CWD, the disease can be transmitted to macaques.
in this project, which began in 2009, 18 macaques were exposed to CWD in a variety of ways: by injecting into the brain, through contact with skin, oral administration, and intravenously (into the bloodstream through veins). So far, results are available from 5 animals. At this point, two animals that were exposed to CWD by direct introduction into the brain, one that was administered infected brain material by oral administration and two that were given infected muscle by oral administration have become infected with CWD. The study is ongoing and testing continues in the remaining animals. The early results will be presented at PRlON 2017, the annual international conference on prion diseases, in Edinburgh, Scotland, May 23 to 26, 2017.
Potential impacts of the new finding
Since 2003 Canada has a policy that recommends that animals and materials known to be infected with prions be removed from the food chain and from health products. Although no direct evidence of CWD prion transmission to humans has ever been recorded, the policy advocates a precautionary approach to managing CWD and potential human exposure to prions. These initial findings do not change Health Canada’s Health Products and Food Branch (HPFB) position on food and health products. A precautionary approach is still recommended to manage the potential risks of exposure to prions through food and health products. Measures are in place at federal, provincial and territorial levels to reduce human exposure to products potentially contaminated by CWD by preventing known infected animals from entering the marketplace.
While Federal and P/T government’s animal disease control policies continue to divert known CWD-infected animals away from entering the food and feed supply, research and development of sensitive detection methods including live-animal sampling techniques remain crucial for ensuring an accurate diagnosis. In addition, consistent federal, provincial and territorial communications of appropriate precautionary measures for hunters and indigenous communities are required.
Next Steps
The CFlA will continue to collaborate with national and international partners to develop and validate new diagnostic techniques. The CFlA will also continue to offer confirmatory testing services and reference laboratory expertise to provincial and territorial partners on demand.
Currently, CFlA laboratories are leading or collaborating on several research projects to understand the potential for CWD to infect humans. These projects use non‐human primates, genetically modified mice, and cell-free amplification approaches. Given the present findings, CFiA encourages continued research into TSEs.
The results of this study reinforce the need to redesign the federal program to foster greater adoption of risk mitigation measures for farmed cervids. Federal and provincial government collaboration will continue as new program options are assessed.
The results of Dr. Czub’s research into CWD will be of interest to scientists, governments, industry and people who consume cervid products. After the presentation at PRION 2017, the research will follow the normal steps of completion, peer review and publication. The Government of Canada will monitor the response to this research and determine whether further review of the science is required. Other studies underway by other researchers may also become public as a result of the presentation of Dr. Czub’s research.
The Public Health Agency of Canada, Health Canada, CFlA and other Federal partners are working together to assess what policies or programs need further review as well as preparing other communications about the research and health policy and advice to Canadian. 2017/04/28
===end...UNOFFICIAL...NO URL LINK...TSS===UPDATE, THE ABOVE INTERNAL DOCUMENT HAS NOW BEEN CONFIRMED, but still no link...TSS===
0:30 First evidence of intracranial and peroral transmission of Chronic Wasting Disease (CWD) into Cynomolgus macaques: a work in progress
Dr Stefanie Czub University of Calgary Faculty of Veterinary Medicine/Canadian Food Inspection Agency Canada
see science to date that the call should be made NOW, that cwd to humans is possible, and all precautions there fore, should be take will great urgency.
WEDNESDAY, MAY 03, 2017
*** First evidence of intracranial and peroral transmission of Chronic Wasting Disease (CWD) into Cynomolgus macaques
LOOKING FOR CWD IN HUMANS AS nvCJD or as an ATYPICAL CJD, LOOKING IN ALL THE WRONG PLACES $$$
*** These results would seem to suggest that CWD does indeed have zoonotic potential, at least as judged by the compatibility of CWD prions and their human PrPC target. Furthermore, extrapolation from this simple in vitro assay suggests that if zoonotic CWD occurred, it would most likely effect those of the PRNP codon 129-MM genotype and that the PrPres type would be similar to that found in the most common subtype of sCJD (MM1).***
Molecular Barriers to Zoonotic Transmission of Prions
*** chronic wasting disease, there was no absolute barrier to conversion of the human prion protein.
*** Furthermore, the form of human PrPres produced in this in vitro assay when seeded with CWD, resembles that found in the most common human prion disease, namely sCJD of the MM1 subtype.
*** The association between venison eating and risk of CJD shows similar pattern, with regular venison eating associated with a 9 FOLD INCREASE IN RISK OF CJD (p = 0.04). ***
*** The association between venison eating and risk of CJD shows similar pattern, with regular venison eating associated with a 9 FOLD INCREASE IN RISK OF CJD (p = 0.04). ***
*** The association between venison eating and risk of CJD shows similar pattern, with regular venison eating associated with a 9 FOLD INCREASE IN RISK OF CJD (p = 0.04). ***
*** The association between venison eating and risk of CJD shows similar pattern, with regular venison eating associated with a 9 FOLD INCREASE IN RISK OF CJD (p = 0.04). ***
There is some evidence that risk of CJD INCREASES WITH INCREASING FREQUENCY OF LAMB EATING (p = 0.02).
The evidence for such an association between beef eating and CJD is weaker (p = 0.14). When only controls for whom a relative was interviewed are included, this evidence becomes a little STRONGER (p = 0.08).
snip...
It was found that when veal was included in the model with another exposure, the association between veal and CJD remained statistically significant (p = < 0.05 for all exposures), while the other exposures ceased to be statistically significant (p = > 0.05).
snip...
In conclusion, an analysis of dietary histories revealed statistical associations between various meats/animal products and INCREASED RISK OF CJD. When some account was taken of possible confounding, the association between VEAL EATING AND RISK OF CJD EMERGED AS THE STRONGEST OF THESE ASSOCIATIONS STATISTICALLY. ...
snip...
In the study in the USA, a range of foodstuffs were associated with an increased risk of CJD, including liver consumption which was associated with an apparent SIX-FOLD INCREASE IN THE RISK OF CJD. By comparing the data from 3 studies in relation to this particular dietary factor, the risk of liver consumption became non-significant with an odds ratio of 1.2 (PERSONAL COMMUNICATION, PROFESSOR A. HOFMAN. ERASMUS UNIVERSITY, ROTTERDAM). (???...TSS)
snip...see full report ;
http://collections.europarchive.org/tna/20090505194948/http://bseinquiry.gov.uk/files/yb/1994/08/00004001.pdf
you can see more evidence here ;
http://chronic-wasting-disease.blogspot.com/2016/05/zoonotic-potential-of-cwd-prions-update.html
Wednesday, May 24, 2017
PRION2017 CONFERENCE VIDEO UPDATE 23 – 26 May 2017 Edinburgh UPDATE 1
In Confidence - Perceptions of unconventional slow virus diseases of animals in the USA - APRIL-MAY 1989 - G A H Wells
3. Prof. A. Robertson gave a brief account of BSE. The US approach was to accord it a very low profile indeed. Dr. A Thiermann showed the picture in the ''Independent'' with cattle being incinerated and thought this was a fanatical incident to be avoided in the US at all costs. ...
snip...see full text ;
Evidence That Transmissible Mink Encephalopathy Results from Feeding Infected Cattle Over the next 8-10 weeks, approximately 40% of all the adult mink on the farm died from TME. snip... The rancher was a ''dead stock'' feeder using mostly (>95%) downer or dead dairy cattle...
In Confidence - Perceptions of unconventional slow virus diseases of animals in the USA - APRIL-MAY 1989 - G A H Wells 3. Prof. A. Robertson gave a brief account of BSE. The US approach was to accord it a very low profile indeed. Dr. A Thiermann showed the picture in the ''Independent'' with cattle being incinerated and thought this was a fanatical incident to be avoided in the US at all costs. ...
The occurrence of CWD must be viewed against the contest of the locations in which it occurred. It was an incidental and unwelcome complication of the respective wildlife research programmes. Despite its subsequent recognition as a new disease of cervids, therefore justifying direct investigation, no specific research funding was forthcoming. The USDA veiwed it as a wildlife problem and consequently not their province! ...page 26.
*** Spraker suggested an interesting explanation for the occurrence of CWD. The deer pens at the Foot Hills Campus were built some 30-40 years ago by a Dr. Bob Davis. At or abut that time, allegedly, some scrapie work was conducted at this site. When deer were introduced to the pens they occupied ground that had previously been occupied by sheep.
Wednesday, May 24, 2017
PRION2017 CONFERENCE VIDEO UPDATE 23 – 26 May 2017 Edinburgh UPDATE 1
Subject: PRION2017 CONFERENCE VIDEO UPDATE 23 – 26 May 2017 Edinburgh
*see archives of previous Prion Conferences, the ones that are still available, scroll down towards bottom in this link.
SUNDAY, JULY 24, 2016
Chronic Wasting Disease Prions in Elk Antler Velvet and Marketing of this Product in Nutritional Supplements for Humans?
Research Project: TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES: THE ROLE OF GENETICS, STRAIN VARIATION, AND ENVIRONMENTAL CONTAMINATION IN DISEASE CONTROL
Title: Chronic Wasting Disease Prions in Elk Antler Velvet
Authors
item Angers, R - UNIVERSITY OF KENTUCKY item Napier, D - UNIVERSITY OF KENTUCKY item Seward, T - UNIVERSITY OF KENTUCKY item Green, M - UNIVERSITY OF KENTUCKY item Spraker, T - COLORADO STATE UNIVERSITY item O'Rourke, Katherine item Balachandran, A - CANADIAN FOOD INSPCTN AG item Telling, G - UNIVERSITY OF KENTUCKY
Submitted to: Emerging Infectious Diseases Publication Type: Peer Reviewed Journal Publication Acceptance Date: February 1, 2009
Publication Date: May 1, 2009 Repository URL: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2687044/pdf/08-1458_finalR.pdf
Citation: Angers RC, Seward TS, Napier D, Green M, Hoover E, Spraker T, et al. 2009. Chronic wasting disease prions in elk antler velvet. Emerg Infect Dis 15(5):696-703.
Interpretive Summary: Chronic wasting disease (CWD) is a fatal neurologic disease of deer and elk in the United States and Canada. The disease is associated with accumulations of infectious proteins in the brain, nervous system, blood, and a limited number of other tissues. In this study, the investigators examined elk antler velvet, the covering that grows on elk antlers every year. Antler velvet is rich in blood and nervous supply and may represent a source of infectious material as the velvet is shed every year. Antler velvet and brain tissue from four infected elk was examined by immunohistochemistry and biochemical methods, with no evidence of the abnormal prion protein in antler velvet. The same preparations were tested in genetically engineered mice susceptible to CWD. Mice in both inoculated groups developed prion disease. This finding demonstrates that antler velvet from CWD infected elk contain infectious material and may represent a risk material to other elk. Technical Abstract: Chronic wasting disease (CWD) is a transmissible spongiform encephalopathy or prion disease of captive and free ranging white tailed deer, mule deer, Rocky Mountain elk and moose in the some parts of the United States and Canada. The presence of the disease has sharply curtailed movement of captive animals and reduced the domestic or international market for some cervid by-products. The disease appears to be transmitted by Rocky Mountain elk relatively late in the disease course, but the sources of the infectious material remain undefined. Brain and lymphoid tissue contain the highest levels of the abnormal prion protein, the marker for disease, and transmission in white tailed deer can be accomplished by blood transfusion from experimentally infected deer to naive deer. In this study, the investigators examined the transmission potential of antler velvet, a highly vascularized and innervated epidermal tissue covering the growing antler. Antler velvet is shed each year and is widely used as a nutritional supplement. Genetically engineered mice susceptible to CWD were inoculated with homogenates of paired brain and antler velvet from 4 elk with CWD. Mice in both groups developed a transmissible spongiform encephalopathy. These findings demonstrate prion infectivity accumulates in antler velvet and may have impact on marketing of this product.
Last Modified: 7/24/2016
Chronic Wasting Disease Prions in Elk Antler Velvet
Rachel C. Angers,1 Tanya S. Seward, Dana Napier, Michael Green, Edward Hoover, Terry Spraker, Katherine O’Rourke, Aru Balachandran, and Glenn C. Telling
Chronic wasting disease (CWD) is a contagious, fatal prion disease of deer and elk that continues to emerge in new locations. To explore the means by which prions are transmitted with high efficiency among cervids, we examined prion infectivity in the apical skin layer covering the growing antler (antler velvet) by using CWD-susceptible transgenic mice and protein misfolding cyclic amplification. Our finding of prions in antler velvet of CWD-affected elk suggests that this tissue may play a role in disease transmission among cervids. Humans who consume antler velvet as a nutritional supplement are at risk for exposure to prions. The fact that CWD prion incubation times in transgenic mice expressing elk prion protein are consistently more rapid raises the possibility that residue 226, the sole primary structural difference between deer and elk prion protein, may be a major determinant of CWD pathogenesis.
snip...
Implications for Horizontal CWD Transmission and Human Exposure
Our studies indicate that antler velvet represents a previously unrecognized source of CWD prions in the environment. Whereas oral transmission of rodent-adapted scrapie prions is known to be ≈5 orders of magnitude less efficient than transmission by intracerebral inoculation (14,15), the relative efficiency of oral CWD prion transmission is unknown. Multiple exposures to low levels of CWD prions in the environment (16,17), as well as increased infectivity when prions are bound to soil minerals (18), are factors that may influence transmission.
The appearance of variant Creutzfeldt-Jakob disease in humans exposed to bovine spongiform encephalopathy (BSE) (19,20) and the demonstration of CWD prions in muscle (3) placed the human species barrier to CWD prions at the forefront of public health concerns. Our studies indicate that antler velvet represents an additional source for human exposure to CWD prions. Widely used in traditional Asian medicine to treat a variety of ailments including impotence, arthritis, and high blood pressure, antler velvet can be readily purchased in caplet form and its usage has increased worldwide.
Fortunately, to date there is no epidemiologic evidence that rates of CJD in the CWD-endemic region (Colorado, USA) have increased (21,22). Also reassuring is the inefficient in vitro conversion of human PrP to protease-resistant PrP by CWD (23). Two studies have shown that CWD prions failed to induce disease in Tg mice expressing human PrP (24,25). However, the failure of BSE to be transmitted to Tg mice expressing human prion protein (HuPrP) was cited as early evidence of a BSE transmission barrier in humans (26); subsequent studies demonstrated a strong effect of the codon 129 polymorphism on transmissibility of BSE prions (27). To date, only mice expressing HuPrP with methionine at 129 have been challenged with CWD. In support of the argument that humans might be susceptible to CWD, intracerebral inoculation of squirrel monkeys produced disease after >30 months (28). Prion strain properties are also critical when considering the potential for interspecies transmission. The existence of multiple CWD strains has been suggested by several studies (4,25,29,30), but strain isolation and host range characterization have not been reported. Finally, it is worth considering that if CWD were to cross the species barrier into humans, this transmission source might not be recognized if the disease profile overlapped with one of the forms of sporadic CJD reported in North America.
snip...end
Volume 15, Number 5—May 2009
Research
Chronic Wasting Disease Prions in Elk Antler Velvet
ABOUT that deer antler spray and CWD TSE PRION...
I have been screaming this since my neighbors mom died from cjd, and she had been taking a supplement that contained bovine brain, bovine eyeball, and other SRMs specified risk materials, the most high risk for mad cow disease.
just saying...
I made a submission to the BSE Inquiry long ago during the BSE Inquiry days, and they seemed pretty interested.
Sender: "Patricia Cantos"
To: "Terry S Singeltary Sr. (E-mail)"
Subject: Your submission to the Inquiry
Date: Fri, 3 Jul 1998 10:10:05 +0100
3 July 1998
Mr Terry S Singeltary Sr.
E-Mail: Flounder at wt.net
Ref: E2979
Dear Mr Singeltary,
Thank you for your E-mail message of the 30th of June 1998 providing the Inquiry with your further comments.
Thank you for offering to provide the Inquiry with any test results on the nutritional supplements your mother was taking before she died.
As requested I am sending you our general Information Pack and a copy of the Chairman's letter. Please contact me if your system cannot read the attachments.
Regarding your question, the Inquiry is looking into many aspects of the scientific evidence on BSE and nvCJD. I would refer you to the transcripts of evidence we have already heard which are found on our internet site at ;
Could you please provide the Inquiry with a copy of the press article you refer to in your e-mail? If not an approximate date for the article so that we can locate it?
In the meantime, thank you for you comments. Please do not hesitate to contact me on...
snip...end...tss
everyone I tell this too gets it screwed up...MY MOTHER WAS NOT TAKING THOSE SUPPLEMENTS IPLEX (that I ever knew of). this was my neighbors mother that died exactly one year _previously_ and to the day of sporadic CJD that was diagnosed as Alzheimer’s at first. my mother died exactly a year later from the Heidenhain Variant of Creutzfeldt Jakob Disease hvCJD, and exceedingly rare strains of the ever growing sporadic CJD’s. _both_ cases confirmed. ...kind regards, terry
TSEs i.e. mad cow disease's BSE/BASE and NUTRITIONAL SUPPLEMENTS
IPLEX, mad by standard process;
vacuum dried bovine BRAIN, bone meal, bovine EYE, veal Bone, bovine liver powder, bovine adrenal, vacuum dried bovine kidney, and vacuum dried porcine stomach.
also;
what about potential mad cow candy bars ?
see their potential mad cow candy bar list too...
THESE are just a few of MANY of just this ONE COMPANY...TSS
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE
Friday, January 19, 2001 snip...
17 But I think that we could exhibit some quite
18 reasonable concern about blood donors who are taking dietary
19 supplements that contain a certain amount of unspecified-
20 origin brain, brain-related, brain and pituitary material.
21 If they have done this for more than a sniff or something
22 like that, then, perhaps, they should be deferred as blood
23 donors.
24 That is probably worse than spending six months in
25 the U.K.
1/19/01
3681t2.rtf(845) page 501
see full text ;
everyone I tell this too gets it screwed up...MY MOTHER WAS NOT TAKING THOSE SUPPLEMENTS IPLEX (that I ever knew of). this was my neighbors mother that died exactly one year _previously_ and to the day of sporadic CJD that was diagnosed as Alzheimer’s at first. my mother died exactly a year later from the Heidenhain Variant of Creutzfeldt Jakob Disease hvCJD, and exceedingly rare strains of the ever growing sporadic CJD’s. _both_ cases confirmed. ...kind regards, terry
TSEs i.e. mad cow disease's BSE/BASE and NUTRITIONAL SUPPLEMENTS
IPLEX, mad by standard process;
vacuum dried bovine BRAIN, bone meal, bovine EYE, veal Bone, bovine liver powder, bovine adrenal, vacuum dried bovine kidney, and vacuum dried porcine stomach.
also;
what about potential mad cow candy bars ?
see their potential mad cow candy bar list too...
THESE are just a few of MANY of just this ONE COMPANY...TSS
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE
Friday, January 19, 2001 snip...
17 But I think that we could exhibit some quite
18 reasonable concern about blood donors who are taking dietary
19 supplements that contain a certain amount of unspecified-
20 origin brain, brain-related, brain and pituitary material.
21 If they have done this for more than a sniff or something
22 like that, then, perhaps, they should be deferred as blood
23 donors.
24 That is probably worse than spending six months in
25 the U.K.
1/19/01
3681t2.rtf(845) page 501
Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients a Comment Number: EC -2 Accepted - Volume 7
see full text ;
2003 - 2004 Product Catalog
Standard Process Inc.
NATURAL COCOA STANDARDBAR (mad cow candy bar) (i will just list animal organs) bovine adrenal, bovine liver, bovine spleen, ovine spleen, bovine kidney...
NATURAL PEANUT BUTTER STANDARDBAR
bovine adrenal, bovine liver, bovine spleen, ovine spleen, bovine kidney...
USF (MAD COW) OINTMENT (RUB A DUB DUB, KURU ETC) ;
bovine orhic glandular extract
UTROPHIN PMG
bovine uterus PMG
VASCULIN
bovine heart PMG extract, veal bone PMG extract, bovine liever, porcine duodenum, bovine adrenal Cytosol extract, bovine spleen, ovine spleen
IPLEX (neighbors mom died from CJD while taking these pills for years)
bovine eye PMG extract, veal bone PMG, bovine liver, porcine stomach, bovine adrenal, bovine kidney, bovine adrenal Cytosol extract, BOVINE BRAIN, bovine bone, veal bone meal
MYO-PLUS
bovine heart PMG, bovine liver, porcine stomach, bovine orchic extract, bovine spleen, ovine spleen, bovine adrenal Cytosol extract, BOVINE BRAIN
NEUROPLEX
bovine orchic Cytosol extract, bovine spleen, BOVINE BRAIN PMG EXTRACT, BOVINE ANTERIOR PITUITARY, bovine liver, BOVINE PITUITARY PMG EXTRACT, AND MORE BOVINE BRAIN...
NEUROTROPHIN PMG
BOVINE BRAIN PMG
NIACINAMIDE B6 VM
bovine liver, porcine stomach, bovine spleen ovine spleen, BOVINE BRAIN
OCULOTROPHIN PMG BOVINE EYE PMG
ORCHEX
bovine liver, bovine orchic Cytosol extract, porcine stomch, bovine spleen, ovine spleen, BOVINE BRAIN
OSTARPLEX
veal bone PMG extract, veal bone PMG extract, bovine liver, porcine stomach, bovine adrenal, bovine spleen, ovine spleen, BOVINE BRAIN
PARAPLEX
bovine pancreas PMG extract, porcine duodenum, bovine adrenal PMG, BOVINE PITUITARY PMG EXTRACT, bovine thyroid PMG extract
PITUITROPHIN PMG
RUMAPLEX
BOVINE BRAIN, veal bone PMG extract, bovine adrenal, bovine prostate Cytosol extract, veal bone meal, bovine liver PMG extract, bovine spleen, ovine spleen, bovine liver
SENAPLEX
bovine liver PMG extract, bovine adrenal, BOVNE BRAIN, veal bone meal, bovine kidney, bovine orchic extract, bovine spleen, ovine spleen ..........
THESE are just a few of MANY of just this ONE COMPANY.
FOR the following reason, I implore that the FDA take serious action in further protecting the consumer from the TSE agent via nutritional supplements.
Does all that e-mail spam promising sexual vitality actually hide serious risk of contracting MAD COW DISEASE?
Volume 361, Number 9368 03 May 2003
Correspondence
Tighter regulation needed for dietary supplements in USA
Sir--Mary Palmer and colleagues (Jan 11, p 101)1 found that dietary supplements have the potential to cause serious adverse effects. The investigators state that research on the hazards and risks of dietary supplements should be a priority. The safety of individuals who consume these products is important, and organisations such as the US Food and Drug Administration (FDA) need to take initiative by enforcing stricter regulations on supplements. Several commonly used products--for example ginkgo biloba, St John's Wort, and ephedrine--can have serious adverse effects.2 Although the FDA requires multiple studies on the safety and efficacy for pharmaceutical products before placing them on the market, standards are less robust for dietary supplements. In the USA, under the Dietary Supplement Health and Education Act (DSHEA) of 1994, supplements are subject to the same regulatory requirements as food. There are no provisions that require FDA approval for the safety or effectiveness of supplements,3 which leaves consumers and manufacturers essentially responsible for the health effects of these products. The DSHEA of 1994 needs to be revised so that dietary supplements are subject to the same regulations as pharmacological drugs. The FDA needs to review clinical studies on the safety and efficacy of dietary supplements. Organisations such as Public Citizen and the American Medical Association are already taking steps to achieve these changes. However, they face immense opposition from groups such as the National Nutritional Foods Association, the American Herbal Association, and the Council for Responsible Nutrition. To overcome such resistance, consumer organisations, health-care providers, and government agencies need to approach this subject in unison. The public needs to be able to assess the risks and benefits of dietary supplements before consuming them. Health-care providers and the more than 100 million Americans who consume these products4 should encourage the FDA to treat supplements with the stringent regulations it enforces on pharmaceutical products.
Nipa Kinariwala
----------------------------------------------------------
700 Bolinwood Drive, Apartment 12A, Chapel Hill, NC 27514, USA (e-mail nskinari at aol.com) 1 Palmer ME, Haller C, McKinney PE, et al. Adverse events associated with dietary supplements: an observational study. Lancet 2003; 361: 101-06. [Text ] 2 Cupp MJ. Herbal remedies: adverse effects and drug interactions. Am Fam Physician 1999; 59: 1239-45. [PubMed ] 3 Unites States Food and Drug Administration. Overview of dietary supplements. Jan 3, 2001. http://www.cfsan.fda.gov/~dms/ds-oview.html (accessed Feb 20, 2002). 4 Pear R. Feds call for tighter control over nutritional supplements. Organic Consumers Association, April 17, 2001. http://www.organicconsumers.org/Organic/dietsupp.cfm (accessed Feb 20, 2002).
snip...end tss letter to fda.
=================== 2013 ================
my plight with Metabolife, the GAO et al, and my submission to the BSE inquiry, about mad cow in a pill ;
Wednesday, March 20, 2013
GAO-13-244, Mar 18, 2013 Dietary Supplements FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Product
From: Terry S. Singeltary Sr.
Sent: Tuesday, March 19, 2013 2:46 PM
To: mailto:gomezj%40gao.gov Cc: mailto:siggerudk%40gao.gov ; mailto:youngc1%40gao.gov ; mailto:oighotline%40gao.gov
Monday, February 01, 2010
Import Alert 17-04 BSE CJD HIGH RISK TISSUES, Nutritional Supplements and Cosmetics Import Alert 17-04
Thursday, March 19, 2009
Chronic Wasting Disease Prions in Elk Antler Velvet (Nutritional Supplements and CJD)
10.3201/eid1505.081458 Suggested citation for this article: Angers RC, Seward TS, Napier D, Green M, Hoover E, Spraker T, et al. Chronic wasting disease prions in elk antler velvet. Emerg Infect Dis. 2009 May; [Epub ahead of print]
Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients a
Comment Number: EC –2
Accepted - Volume 7
Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients a Comment Number: EC -2 Accepted - Volume 7
snip...
what did Paul Brown say about this previously;
i bring your attention to (page 500) Dr. Paul Brown statements;
253 1 DR. BOLTON: I have an additional question about 2 that. What is the assurance that additional locally sourced 3 tracheas are not added into that manufacturing process, thus 4 boosting the yield, if you will, but being returned to the 5 U.S. as being produced from U.S.-sourced raw material? 6 DR. McCURDY: Are there data to indicate how many 7 grams, or whatever, of infected brain are likely to infect 8 an organism, either animal or man, when taken orally? 9 DR. BROWN: If I am not mistaken, and I can be 10 corrected, I think a half a gram is enough in a cow, orally; [FULL TEXT ABOUT 600 PAGES] 3681t2.rtf
snip...
Unregulated "foods" such as 'nutritional supplements' containing various extracts from ruminants, whether imported or derived from 3 US cattle/sheep/cervids ("antler velvet" extracts!) should be forbidden or at least very seriously regulated.
(neighbors Mom, whom also died from CJD, had been taking bovine based supplement, which contained brain, eye, and many other bovine/ovine tissues for years, 'IPLEX').
my plight with metabolife and there 'bovine complex' about risk factors of TSE in there product ;
Terry S. Singeltary Sr. wrote:
######## Bovine Spongiform Encephalopathy > > #########
1. Dietary Supplements: Review of Health-Related Call Records for
Users of Metabolife 356. GAO-03-494, March 31.
-------- Original Message --------
Subject: METABOLIFE AND TSEs GAO-03-494 ''URGENT DATA''
Date: Thu, 01 May 2003 11:23:01 –0500
From: "Terry S. Singeltary Sr."
To: NelliganJ at gao.gov
The General Accounting Office (GAO) today released the following reports and testimonies: ‘'
REPORTS;
1. Dietary Supplements: Review of Health-Related Call Records for
Users of Metabolife 356. GAO-03-494, March 31.
GREETINGS GAO:
i was suprised that i did not see any listing of bovine tissue in > metabolife on it's label. have they ceased using these desiccated tissues???
i see that the lable on this product METABOLIFE 356, does not state that it has any tissues of desiccated bovine organs? i no > the product use to, so i am curious if they have ceased the use of the tissues of cattle they _use_ to use (see below)???
METABOLIFE 356
BOVINE COMPLEX/GLANDULAR SYSTEM
OVARIES, PROSTATE, SCROTUM AND ADRENAL
USDA SOURCE CATTLE
i tried warning them years ago of this potential threat of CJD/TSEs;
From: Randy Smith
To: "'flounder at wt.net'"
Subject: Metabolife
Date: Mon, 7 Dec 1998 14:21:35 –0800
Dear Sir,
We are looking at reformulation. I agree that slow virus diseases present a problem in some areas of the world.
Our product uses healthy USDA inspected cattle for the glandular extract.
If you have any links to more information on this subject I would like to examine them.
Thank you for your interest and concern,
Dr. Smith
============
From: Randy Smith
To: "'flounder at wt.net'"
Subject: RE: [Fwd: Your submission to the Inquiry]
Date: Wed, 9 Dec 1998 10:37:07 –0800
Terry,
Thank you for your note and the information links you forwarded to me.
I am new to Metabolife International, however hopefully as my role here enlarges I well have a greater impact on formulation and product development.
Metabolife International does believe in placing safety first. And I am going to do my best to see that we continue to do so.
Sincerely,
Dr. Smith
============
-----Original Message-----
From: Terry S. Singeltary Sr. [mailto:flounder at wt.net]
Sent: Wednesday, December 09, 1998 5:49 PM
To: rsmith at metabolife.com
Subject: [Fwd: Your submission to the Inquiry]
Dr. Smith, I am truly impressed with you honesty, THANKS.....I am not just spouting off about the potential dangers, here. THEY ARE REAL.....I have forwarded an e-mail from the BSE Inquiry, in which I made a statement about them........You might want to go to the site and read through it........IT WILL TAKE A WHILE........ THINGS ARE HAPPENING HERE SIR, THAT YOU ARE NOT AWARE OF, AND AS MOST PEOPLE ARE NOT...............I JUST HOPE, THAT THE REFORMULATION YOU SPEAK OF, IS IN FACT GOING TO TAKE PLACE.
The Department of Health, here in the U.S., is also worried about the potential dangers involved hear............Terry/MADSON
==================================================
From: Randy Smith
To: "'flounder at wt.net'"
Subject: RE: [Fwd: MEDICINES "GREATER BSE RISK THAN BEEF"!!!!]
Date: Fri, 18 Dec 1998 09:55:17 –0800
Return-Receipt-To: Randy Smith
Thanks very much for the info. I appreciate all these articles I can get. It does sound very familiar - just follow the green ($) trail.
-----Original Message-----
From: Terry S. Singeltary Sr. [mailto:flounder at wt.net]
Sent: Friday, December 18, 1998 5:15 PM
To: rsmith at metabolife.com
Subject: [Fwd: MEDICINES "GREATER BSE RISK THAN BEEF"!!!!]
Randy, thought you might be interested in > > this...............MADSON!!!!!1
snip...
===============================
-------- Original Message --------
Subject: re: METABOLIFE AND TSEs GAO-03-494 ''URGENT DATA''
Date: Thu, 01 May 2003 16:04:35 –0400
From: "Marcia G Crosse"
To:
CC: "Charles W Davenport" , "Carolyn Feis Korman" > > , "Martin Gahart" >
Mr. Singletary,
We were informed by representatives of Metabolife, Inc. that Metabolife 356 was reformulated to remove bovine complex as an ingredient in the product, approximately September 2001. We did not independently verify the contents of the product.
Sincerely,
Marcia Crosse
Acting Director
Health CarePublic Health and Science Issues
U.S. General Accounting Office
441 G Street, N.W.
Washington, D.C. 20548
===================
-------- Original Message --------
Subject: Re: METABOLIFE AND TSEs GAO-03-494 ''URGENT DATA''
Date: Thu, 01 May 2003 15:48:52 –0500
From: "Terry S. Singeltary Sr."
To: Marcia G Crosse
CC: Charles W Davenport , Carolyn Feis Korman > > , Martin Gahart > References: > >
THANK YOU!
MIRACLES DO HAPPEN! ;-)
now all we need to do is;
snip......
one small step for man, one giant leap for mankind ;-)
however;
''We did not independently verify the contents of the product''
???
TSS
####### http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ########
Could you get mad cow from a pill ? Some doctors say a class of pills that promise smarts, energy, and sexual vitality may cause mad-cow disease.
The government isn't worried. Should you be?
June 1, 2001
Health Magazine
by Susan Freinkel
The German Magazine Der Spiegel came out to the house here and interviewed me in 2001 (I think), about that token purina mad cow feed mill blunder, and they were very concerned about these type supplements that carried the SRMs that could very well carry the TSE prion agent. ...please see ;
GERMAN DER SPIEGEL MAGAZINEDie
BSE-Angst erreicht Amerika: Trotz strikter Auflagen gelangte in Texas verbotenes Tiermehl ins Rinderfutter - die Kontrollen der Aufsichtsbehörden sind lax.
DER SPIEGEL (9/2001) - 24.02.2001 (9397 Zeichen) USA: Loch in der Mauer Die BSE-Angst erreicht Amerika: Trotz strikter Auflagen gelangte in Texas verbotenes Tiermehl ins Rinderfutter - die Kontrollen der Aufsichtsbehördensind lax.Link auf diesen Artikel im Archiv:
"Löcher wie in einem Schweizer Käse" hat auch Terry Singeltary im Regelwerk der FDA ausgemacht. Der Texaner kam auf einem tragischen Umweg zu dem Thema: Nachdem seine Mutter 1997 binnen weniger Wochen an der Creutzfeldt-Jakob-Krankheit gestorben war, versuchte er, die Ursachen der Infektion aufzuspüren. Er klagte auf die Herausgabe von Regierungsdokumenten und arbeitete sich durch Fachliteratur; heute ist er überzeugt, dass seine Mutter durch die stetige Einnahme von angeblich kräftigenden Mitteln erkrankte, in denen - völlig legal - Anteile aus Rinderprodukten enthalten sind.
Von der Fachwelt wurde Singeltary lange als versponnener Außenseiter belächelt. Doch mittlerweile sorgen sich auch Experten, dass ausgerechnet diese verschreibungsfreien Wundercocktails zur Stärkung von Intelligenz, Immunsystem oder Libido von den Importbeschränkungen ausgenommen sind. Dabei enthalten die Pillen und Ampullen, die in Supermärkten verkauft werden, exotische Mixturen aus Rinderaugen; dazu Extrakte von Hypophyse oder Kälberföten, Prostata, Lymphknoten und gefriergetrocknetem Schweinemagen. In die USA hereingelassen werden auch Blut, Fett, Gelatine und Samen. Diese Stoffe tauchen noch immer in US-Produkten auf, inklusive Medizin und Kosmetika. Selbst in Impfstoffen waren möglicherweise gefährliche Rinderprodukte enthalten. Zwar fordert die FDA schon seit acht Jahren die US-Pharmaindustrie auf, keine Stoffe aus Ländern zu benutzen, in denen die Gefahr einer BSE-Infizierung besteht. Aber erst kürzlich verpflichteten sich fünf Unternehmen, darunter Branchenführer wie GlaxoSmithKline, Aventis und American Home Products, ihre Seren nur noch aus unverdächtigem Material herzustellen.
"Its as full of holes as Swiss Cheese" says Terry Singeltary of the FDA regulations. ...
Sunday, November 10, 2013
LARGE CJD TSE PRION POTENTIAL CASE STUDY AMONG HUMANS WHO TAKE DEER ANTLER VELVET WILL BE ONGOING FOR YEARS IF NOT DECADES, but who's cares $
Tuesday, August 16, 2016
Docket No. FDA-2011-D-0376 Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Revised Draft Guidance for Industry Singeltary Submission
TUESDAY, JUNE 13, 2017
Pennsylvania Chronic Wasting Disease CWD TSE PRION Senate Joint Hearing Tuesday, June 13, 2017
MONDAY, JUNE 19, 2017
FDA DOES NOT have mandatory established specifications for animal-derived ingredients to ensure they are BSE free in Nutritional Supplements
Subject: Use of Materials Derived From Cattle in Human Food and Cosmetics [Docket No. 2004N-0081] RIN 0910-AF47
Date: April 17, 2008 at 2:41 pm PST
[Federal Register: April 17, 2008 (Volume 73, Number 75)] [Rules and Regulations] [Page 20785-20794] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr17ap08-7]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 189 and 700
[Docket No. 2004N-0081] RIN 0910-AF47
Use of Materials Derived From Cattle in Human Food and Cosmetics
AGENCY: Food and Drug Administration, HHS.
ACTION: Interim final rule and request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending its regulations on the use of materials derived from cattle in human food and cosmetics. In these regulations, FDA has designated certain materials from cattle as ``prohibited cattle materials'' and has banned the use of such materials in human food, including dietary supplements, and in cosmetics. Prohibited cattle materials include specified risk materials (SRMs), the small intestine of all cattle unless the distal ileum is removed, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, or mechanically separated (MS) (Beef). Specified risk materials include the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months of age and older, and the tonsils and distal ileum of the small intestine of all cattle. FDA is amending its regulations so that FDA may designate a country as not subject to certain bovine spongiform encephalopathy (BSE)-related restrictions applicable to FDA regulated human food and cosmetics. A country seeking to be so designated must send a written request to the Director of FDA's Center for Food Safety and Applied Nutrition, including information about the country's BSE case history, risk factors, measures to prevent the introduction and transmission of BSE, and any other relevant information.
DATES: This interim final rule is effective July 16, 2008. Submit written or electronic comments on this interim final rule by July 16, 2008. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by May 19, 2008 (see the ``Paperwork Reduction Act of 1995'' section of this document).
snip...
Table 1.--Top 10 Countries Exporting Specified North American Industry Classification System (NAICS) Code Products to United States for 2006 NAICS 311611\1\--Meat Products (Excluding Quantity (thousands of Poultry) kilograms)\2\ ¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤ Canada 681,899 ------------------------------------------------------------------------ Australia 376,585 ------------------------------------------------------------------------ New Zealand 211,873 ------------------------------------------------------------------------ Uruguay 103,305 ------------------------------------------------------------------------ Brazil 83,897 ------------------------------------------------------------------------ Denmark 46,652 ------------------------------------------------------------------------ Mexico 35,553 ------------------------------------------------------------------------ China 28,530 ------------------------------------------------------------------------ Argentina 22,353 ------------------------------------------------------------------------ Nicaragua 21,303 ¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤ NAIC 311613--Animal Fats, Oils, & By- (thousands of Products kilograms)\3\ ¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤ Canada 94,306 ------------------------------------------------------------------------ New Zealand 32,550 ------------------------------------------------------------------------ China 7,809 ------------------------------------------------------------------------ Australia 6,807 ------------------------------------------------------------------------ Brazil 6,589 ------------------------------------------------------------------------ Mexico 2,130 ------------------------------------------------------------------------ Colombia 1,826 ------------------------------------------------------------------------ Germany 1,642 ------------------------------------------------------------------------ Ecuador 1,149 ------------------------------------------------------------------------ Japan 1,138 ------------------------------------------------------------------------ \1\
The NAIC code 31161 covers the animal slaughtering and processing industry. The industry is composed of establishments that are primarily engaged in one or more of the following: (1) Slaughtering animals, (2) preparing processed meats and meat by-products, and (3) rendering and refining animal fat, bones, and meat scraps. The subcategory 311611 comprises those establishments primarily engaged in slaughtering animals (except poultry and small game). Establishments that slaughter and prepare meats are included in this classification. (Ref. 5) We use this data as an indicator of the countries that are most likely to petition FDA regarding their BSE status. \2\ These figures do not include exports measured in ``clean yield kilograms'' and ``pieces.'' \3\ These figures do not include exports measured in ``grams,'' ``liters,'' ``metric tons,'' and ``pieces.''
We do not know how many countries might petition the FDA. However, taking into consideration the previous information on countries officially recognized as having a negligible BSE risk or being provisionally free of BSE under OIE, as well as the information in table 1 on countries that export large amounts of meat products and animal fats, oils, and byproducts to the United States, we are estimating for this analysis that 10 countries may be interested in petitioning FDA to be excepted from certain BSE-related restrictions applicable to human food and cosmetics. Our estimate is not intended to suggest that all of these countries would be able to qualify for a designation under Sec. Sec. 189.5(e) and 700.27(e). 3. Costs and Benefits of Exemption Provision
snip...$$$
http://edocket.access.gpo.gov/2008/08-1142.htm
http://edocket.access.gpo.gov/2008/pdf/08-1142.pdf
GWs BSE MRR policy, the legal trading of all strains of TSE globally $$$
February 18, 2004
Preeminent Scientists Protest Bush Administration's Misuse of Science Nobel Laureates, National Medal of Science Recipients, and Other Leading Researchers Call for End to Scientific Abuses
Call (2MB mp3) Washington, D.C.—Today, more than 60 leading scientists—including Nobel laureates, leading medical experts, former federal agency directors and university chairs and presidents—issued a statement calling for regulatory and legislative action to restore scientific integrity to federal policymaking. According to the scientists, the Bush administration has, among other abuses, suppressed and distorted scientific analysis from federal agencies, and taken actions that have undermined the quality of scientific advisory panels. “Across a broad range of issues, the administration has undermined the quality of the scientific advisory system and the morale of the government’s outstanding scientific personnel,” said Dr. Kurt Gottfried, emeritus professor of physics at Cornell University and Chairman of the Union of Concerned Scientists. “Whether the issue is lead paint, clean air or climate change, this behavior has serious consequences for all Americans.”
“Science, to quote President Bush's father, the former president, relies on freedom of inquiry and objectivity,” said Russell Train, head of the Environmental Protection Agency under Nixon and Ford, who joined the scientists in calling for action. “But this administration has obstructed that freedom and distorted that objectivity in ways that were unheard of in any previous administration.”
The statement notes that while scientific input to the government is rarely the only factor in public policy decisions, this input should be weighed from an objective and impartial perspective. However, the administration of George W. Bush has disregarded this principle.
“The Earth system follows laws which scientists strive to understand,” said Dr. F. Sherwood Rowland a Nobel laureate in chemistry. “The public deserves rational decisionmaking based on the best scientific advice about what is likely to happen, not what political entities might wish to happen.”
“We are not simply raising warning flags about an academic subject of interest only to scientists and doctors,” said Dr. Neal Lane, a former director of the National Science Foundation and a former Presidential Science Advisor. “In case after case, scientific input to policymaking is being censored and distorted. This will have serious consequences for public health.”
In conjunction with the statement, the Union of Concerned Scientists today released a report Scientific Integrity in Policymaking that investigates numerous allegations in the scientists’ statement involving censorship and political interference with independent scientific inquiry at the Environmental Protection Agency, the Food and Drug Administration, and the Departments of Health and Human Services, Agriculture, Interior and Defense.
One example cited in the statement and report involves the suppression of an EPA study that found the bipartisan Senate Clear Air bill would do more to reduce mercury contamination in fish and prevent more deaths than the administration's proposed Clear Skies Act. “This is akin to the White House directing the National Weather Service to alter a hurricane forecast because they want everyone to think we have clear skies ahead,” said Kevin Knobloch, president of the Union of Concerned Scientists “The hurricane is still coming, but without factual information no one will be ready for it.”
Comparing President Bush with his father, George H.W. Bush and former president Richard M. Nixon, the statement warned that had these former presidents similarly dismissed science in favor of political ends, over 200,000 deaths and millions of respiratory and cardiovascular disease cases would not have been prevented with the signing of the original Clean Air Act and the 1990 amendments to that Act.
The statement demands that the Bush administration’s “distortion of scientific knowledge for partisan political ends must cease” and calls for Congressional oversight hearings, guaranteed public access to government scientific studies and other measures to prevent such abuses in the future. The statement further calls on the scientific, engineering and medical communities to work together to reestablish scientific integrity in the policymaking process.
# # # Among the statement signers are:
Philip W. Anderson*† David Baltimore*† Paul Berg*† Lewis Branscomb Thomas Eisner* Jerome Friedman† Richard Garwin* Walter Kohn*† Neal Lane Leon Lederman*† Mario Molina† W.H.K. Panofsky* F. Sherwood Rowland† J. Robert Schrieffer*† Richard Smalley† Harold E. Varmus† Steven Weinberg*† E.O Wilson*
* National Medal of Science † Nobel laureate
-------- Original Message --------
Subject: Docket No. 2004N-0081 and or RIN number RIN-0910-AF47 Use of Materials Derived From Cattle in Human Food and Cosmetics [comment submission]
Date: Tue, 13 Jul 2004 16:08:38 -0500
From: "Terry S. Singeltary Sr." To: fdadockets@oc.fda.gov
CC: burt.pritchett@fda.gov, Agriculture@mail.house.gov
COMMENT SUBMISSION [Docket No. 2004N-O081] RIN-0910--AF47 Use of Materials Derived From Cattle in Human Food and Cosmetics http://www.fda.gov/OHRMS/DOCKETS/98fr/04n-0081-nir0001.pdf
Greetings FDA,
I would kindly like to comment on the potential for TSE transmission from cosmetics to humans and why I think that ALL animal by-products should be excluded from cosmetics. IF we look at the TSE 'KURU'. Kuru is a transmissible spongiform encephalopathy that was identified in Papua New Guinea in the late 1950s. Several thousand cases of the disease occurred during a period of several decades. Epidemiologic investigations implicated ritual endocannibalistic funeral feasts as the likely route through which the infectious agent was spread. The incubation period in females was estimated to be shorter than that in males. The shortest incubation periods were estimated in adult women, who may have been exposed to the largest doses of infectious material. MY question is, was the woman exposed to larger doses, are was it the route of the agent that may have been the factor of shorter incubation in woman, or both?
What is Kuru? Kuru is a rare and fatal brain disorder that occurred at epidemic levels during the 1950s-60s among the Fore people in the highlands of New Guinea. The disease was the result of the practice of ritualistic cannibalism among the Fore, in which relatives prepared and consumed the tissues (including brain) of deceased family members. Brain tissue from individuals with kuru was highly infectious, and the disease was transmitted either through eating or by contact with open sores or wounds. Government discouragement of the practice of cannibalism led to a continuing decline in the disease, which has now mostly disappeared.
snip...
PLEASE NOTE the later ''or by contact with open sores or wounds.''
> and the disease was transmitted either through eating or by contact > with open sores or wounds.
> the Fore women would scoop the brains of their dead relatives out of > their skulls by hand before cooking. They then wiped the residual > liquid and cadaver tissue over their paint-daubed bodies, leaving it > caked in their hair and on their bodies for weeks after a mortuary feast.
Jennifer Cooke: kuru deaths continue in 1999
Sydney Morning Herald, Saturday, August 28, 1999
TSE INFECTION does takes place when the skin surface has been broken by scarification (Taylor et al, 1996).
The transmission of KURU into animals supported the belief that the disease had been transmitted through ceremonial cannibalistic rituals in New Guinea with a possible route of spread involving handling fresh tissue and inoculation through mucous membranes and wounds including skin abrasions (Gajdusek, 1977)
Masters, C.J., Gajdusek, D.C. and Gibbs, C.J., (1980). The spongiform encephalopathies: the natural history of CJD and its relationship to kuru and scrapie.
* Gajdusek D.C. (1996). Kuru: From the New Guinea field journals 1957-1962. Grand Street, 15:6-33
* Gajdusek D.C. (1973). Kuru in the New Guinea Highlands. In Spillane JD (ed): Tropical Neurology. New York, Oxford University Press.
* Gajdusek D.C., Gibbs C.J., and M. Alpers (1966). Experimental transmission of a kuru-like syndrome to chimpanzees. Nature, 209:794.
* Lindenbaum S. (1979). Kuru Sorcery. Mountain View, Ca, Mayfield Publishing Company.
SCCNFP/0724/03, final THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS OPINION CONCERNING USE OF SPECIFIED RISK MATERIAL IN COSMETICS CLARIFICATION FOR TALLOW DERIVATIVES adopted by the SCCNFP on 30 July 2003 by means of the written procedure SCCNFP/0724/03, final Opinion on the Use of specified risk material in cosmetics - Clarification for tallow derivatives ____________________________________________________________________________ _________________ 2 1. Background
snip...
> 4. For GBR-C III and IV countries, tallow derivatives are safe if, in > addition to the above > (3), the specific risk materials have been removed and are not used > for the production of > tallow/tallow derivatives.
PLEASE NOTE, under the old BSE GBR, the USA would be re-classified as at least a GBR III risk assessment, if not a GBR IV in my opinion due to the misgivings from USDA/APHIS et al, some documented below in my references from Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission).
Report on the Assessment of the Geographical BSE - Risk of USA (July 2000) (220kb)
snip...end
-------- Original Message --------
Subject: Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission)
Date: Sun, 11 Jul 2004 21:34:22 -0500
From: "Terry S. Singeltary Sr."
To: fdadockets@oc.fda.gov
CC: regulations@aphis.usda.gov, burt.pritchett@fda.gov
Docket No. 04-047-l No. 04-021ANPR No. 2004N-0264 NEW BSE SAFEGUARDS Federal Measures to Mitigate BSE Risks: Considerations for Further Action http://www.fda.gov/cvm/index/updates/bseanprm.htm
Greetings FDA,
USDA and APHIS et al, I would kindly like to comment on the continued delay of the regulations that have been proposed for years to reduce the risk of BSE/TSE in the USA. Each day that is wasted debating this issue allows this agent to spread, and many many more humans and animals become needlessly exposed to this agent via a multitude of potential routes and sources right here in the USA. TO continue to ignore the new findings from several scientists about the fact that BSE is not the only strain of TSE in cattle, the fact that new atypical strains of TSE are showing up in not only cattle, but sheep and the fact that the new strain of TSE in cattle seems to be more similar to sporadic CJD as opposed to the nv/v CJD, to continue to ignore these findings will only further spread this agent. CWD and Scrapie have been running rampant in the USA for decades. BOTH of which have been rendered and fed back to animals for human/animal consumption for decades. All of which transmits to primates by the natural and non-forced oral consumption of TSE scrapie, CJD, Kuru agent (and CWD by inoculation). Strong Scientific evidence discovered back in the 80s support the fact that a TSE has been prevalent in the USA bovine for decades, either undetected or ignored. IF you consider the recent stumbling and staggering TEXAS cow that was showing all signs of a CNS/TSE disorder that was ordered to be rendered without BSE/TSE test, brains, spinal cord, head and all (as to no possible evidence left of TSE), I would think the 'ignored' or 'covered up' to be the better terminology. Then you have the Downer in Washington state that was actually a good walker and then all the banned Canadian products that some how found it's way across the border into the USA, considering all this, it is very difficult for me to believe that the FDA/USDA/APHIS et al are doing everything possible to protect the 'consumer'. Hardly the case;
Congressman Henry Waxmans Letter to the Honorable Ann Veneman
snip...
From: TSS
Subject: Re: Docket No. 2004N-0081 Use of Materials Derived From Cattle in Human Food and Cosmetics [TSS SUBMISSION]
Date: September 7, 2005 at 7:35 pm PST
In Reply to: Docket No. 2004N-0081 Use of Materials Derived From Cattle in Human Food and Cosmetics posted by TSS on September 7, 2005 at 7:07 am:
----- Original Message -----
From: Terry S. Singeltary Sr.
To: fdadockets@oc.fda.gov
Sent: Wednesday, September 07, 2005 9:44 PM
Subject: Use of Materials Derived From Cattle in Human Food and Cosmetics [Docket No. 2004N-0081] RIN 0910-AF47
Greetings FDA,
I would kindly like to comment on ;
Use of Materials Derived From Cattle in Human Food and Cosmetics [Docket No. 2004N-0081] RIN 0910-AF47
SUMMARY: The Food and Drug Administration (FDA) is amending the interim final rule on use of materials derived from cattle in human food and cosmetics published in the Federal Register of July 14, 2004. In the July 14, 2004, interim final rule, FDA designated certain materials from cattle, including the entire small intestine, as ``prohibited cattle materials'' and banned the use of such materials in human food, including dietary supplements, and in cosmetics. FDA is taking this action in response to comments received on the interim final rule. Information was provided in comments that persuaded the agency that the distal ileum, one of three portions of the small intestine, could be consistently and effectively removed from the small intestine, such that the remainder of the small intestine, formerly a prohibited cattle material, could be used for human food or cosmetics. We (FDA) are also clarifying that milk and milk products, hide and hide-derived products, and tallow derivatives are not prohibited cattle materials. Comments also led the agency to reconsider the method cited in the interim final rule for determining insoluble impurities in tallow and to cite instead a method that is less costly to use and requires less specialized equipment. FDA issued the interim final rule to minimize human exposure to materials that scientific studies have demonstrated are highly likely to contain the bovine spongiform encephalopathy (BSE) agent in cattle infected with the disease. FDA believes that the amended provisions of the interim final rule provide the same level of protection from human exposure to the agent that causes BSE as the original provisions. ...
I would kindly like to submit the following ;
I find it very very disturbing that FDA now takes the position;
>>>Information was provided in comments that persuaded the agency that the distal ileum, one of three portions of the small intestine, could be consistently and effectively removed from the small intestine, such that the remainder of the small intestine, formerly a prohibited cattle material, could be used for human food or cosmetics. <<<
TSE science is emerging and the old testing techniques for TSEs are becoming much more sensitive than when some of these old BSE tissue bio-assays were done in the distant past. I urge once again for the FDA and the USDA to put forth sound science instead of the political and corporate science they have floundered with for the last 3 decades. THERE is much new data out that dispute the position the FDA/USDA have taken on SRMs.
STATEMENT ON INFECTIVITY IN BOVINE TONSIL
Background
1. The views of the Committee were sought on unpublished results from an
ongoing long-term study of the pathogenesis of BSE in cattle. This study is
being carried out by the Veterinary Laboratory Agency and is funded by the
Food Standards Agency (FSA).
2. In this study, cattle were orally dosed with 100g of BSE-infected bovine
brain material. At various times after oral dosing, cattle were killed and
different tissues tested for infectivity. In the first instance, the presence of
infectivity was assessed by injection of various tissues into inbred mice
("mouse bioassay "). In this research infectivity was detected in:
• distal ileum (the earliest infectivity was detected at 6 months after
inoculation.)
• brain and spinal cord and closely associated nervous tissue
(infectivity was detected in the months just prior to the clinical onset
of BSE in cattle)
• at a single time point (around the time of clinical onset) bone marrow
was also found to contain infectivity. ...snip
http://www.seac.gov.uk/statements/tonsil211002.pdf
UPDATE OF THE OPINION ON
TSE INFECTIVITY DISTRIBUTION IN RUMINANT TISSUES
INITIALLY ADOPTED BY
THE SCIENTIFIC STEERING COMMITTEE
AT ITS MEETING OF 10-11 JANUARY 2002
AND AMENDED AT ITS MEETING OF 7-8 NOVEMBER 2002
following the submission of (1) a risk assessment by the German Federal Ministry of
Consumer Protection, food and Agriculture and (2) new scientific evidence
regarding BSE infectivity distribution in tonsils
3. New work, work still in progress and future work
The infectivity of neural and non-neural tissues by intracerebral inoculation of cattle is being
assayed in projects M03006 and M03007. These studies are important since it is possible
that some tissues may not yet have been found to be infective, due to the fact that
infectivity in these tissues is below the detection limits of the tests applied so far. To date,
this study has shown infectivity in CNS tissues, the distal ileum, tonsil tissue and the
nictitating membrane (the nictitating membrane is also known as the third eyelid). Other
challenged and control cattle continue to be closely monitored for clinical signs of BSE.
Research is ongoing to determine the susceptibility of other food animal species to TSEs.
These include a project to determine the susceptibility of pigs to scrapie through oral
exposure (M03005) and a project to further study the transmission of BSE to pigs (M03010).
Project M03024 aims to determine whether UK red deer are susceptible to BSE by oral
exposure. These studies are important since it is highly probable that pigs and deer were
historically exposed to ruminant derived meat and bone meal (MBM). ...
TSEs And The Environment
The LANCET Volume 351, Number 9110 18 April 1998
BSE: the final resting place
snip...
The first matter to consider is the distribution of infectivity in the bodies of infected animals. The brain (and more generally, the central nervous system) is the primary target in all transmissible spongiform encephalopathies (TSE), and it contains by far the highest concentration of the infectious agent. In naturally occuring disease, infectivity may reach levels of up to about one million lethal doses per gram of brain tissue, whether the disease be kuru, CJD, scrapie, or BSE. The infectious agent in BSE-infected cattle has so far been found only in brain, spinal cord, cervical and thoracic dorsal root ganglia, trigeminal ganglia, distal ileum, and bone marrow.4 However, the much more widespread distribution of low levels of infectivity in human beings with kuru or CJD, and in sheep and goats with scrapie, suggests that caution is advisable in prematurely dismissing as harmless other tissues of BSE-infected cattle.
snip...end...TSS
snip...
BY reducing or weakening the SRM list due to the Economic Impact of BSE on the U.S. Beef Industry and while doing so, ignoring all 'sound science', again the FDA/USDA et al are willing to put every human and animal out there at risk to further exposure to this TSE agent, all for a buck. this is not 'sound science' this is what i call 'corporate science', and it is and will continue to expose people. some of these people will die from this agent either directly or indirectly via a multitude of scientific proven routes and sources. WE must remove all political and corporate science from TSE research.
I find it disturbing that products that carry SRMs are still on the market for humans such as nutritional supplements ;
ODD, I just picked up a catalog from STANDARD PROCESS INC. 2003 - 2004 Product Catalog (a chiropractor had just left this catalog in my wife's foot doctors office 4/5/05) and it's full of THOSE SRMS FOR HUMANS. I wonder how much is still left on the market, and how much is still in production, how much crosses the borders? 5 pages of products full of SRMs for humans. THIS is a really fine catalog, i am just now going over. LOADED with SRMs for humans. NO wonder my neighbors mom died from CJD while taking these damn mad cow pills. THEY even have a candy bars loaded with SRMs. HERE is one ;
NATURAL COCOA STANDARDBAR (mad cow candy bar) (i will just list animal organs)
bovine adrenal, bovine liver, bovine spleen, ovine spleen, bovine kidney...
NATURAL PEANUT BUTTER STANDARDBAR
bovine adrenal, bovine liver, bovine spleen, ovine spleen, bovine kidney...
USF (MAD COW) OINTMENT (RUB A DUB DUB, KURU ETC) ;
bovine orhic glandular extract
UTROPHIN PMG
bovine uterus PMG
VASCULIN
bovine heart PMG extract, veal bone PMG extract, bovine liever, porcine duodenum, bovine adrenal Cytosol extract, bovine spleen, ovine spleen (some yummy stuff)
IPLEX (neighbors mom died from CJD while taking these pills for years)
bovine eye PMG extract, veal bone PMG, bovine liver, porcine stomach, bovine adrenal, bovine kidney, bovine adrenal Cytosol extract, BOVINE BRAIN, bovine bone, veal bone meal
MYO-PLUS
bovine heart PMG, bovine liver, porcine stomach, bovine orchic extract, bovine spleen, ovine spleen, bovine adrenal Cytosol extract, BOVINE BRAIN
NEUROPLEX
bovine orchic Cytosol extract, bovine spleen, BOVINE BRAIN PMG EXTRACT, BOVINE ANTERIOR PITUITARY, bovine liver, BOVINE PITUITARY PMG EXTRACT, AND MORE BOVINE BRAIN... HOLY MAD COW IN A PILL !!!
NEUROTROPHIN PMG
BOVINE BRAIN PMG
NIACINAMIDE B6 VM
bovine liver, porcine stomach, bovine spleen ovine spleen, BOVINE BRAIN
OCULOTROPHIN PMG BOVINE EYE PMG
ORCHEX
bovine liver, bovine orchic Cytosol extract, porcine stomch, bovine spleen, ovine spleen, BOVINE BRAIN
OSTARPLEX
veal bone PMG extract, veal bone PMG extract, bovine liver, porcine stomach, bovine adrenal, bovine spleen, ovine spleen, BOVINE BRAIN
PARAPLEX
bovine pancreas PMG extract, porcine duodenum, bovine adrenal PMG, BOVINE PITUITARY PMG EXTRACT, bovine thyroid PMG extract
PITUITROPHIN PMG
RUMAPLEX
BOVINE BRAIN, veal bone PMG extract, bovine adrenal, bovine prostate Cytosol extract, veal bone meal, bovine liver PMG extract, bovine spleen, ovine spleen, bovine liver
SENAPLEX
bovine liver PMG extract, bovine adrenal, BOVNE BRAIN, veal bone meal, bovine kidney, bovine orchic extract, bovine spleen, ovine spleen ..........
THESE are just a few of MANY of just this ONE COMPANY.
Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients a Comment Number: EC -2 Accepted - Volume 7
253 1 DR. BOLTON:
I have an additional question about
2 that. What is the assurance that additional locally sourced
3 tracheas are not added into that manufacturing process, thus
4 boosting the yield, if you will, but being returned to the
5 U.S. as being produced from U.S.-sourced raw material?
6 DR. McCURDY: Are there data to indicate how many
7 grams, or whatever, of infected brain are likely to infect
8 an organism, either animal or man, when taken orally?
9 DR. BROWN: If I am not mistaken, and I can be
10 corrected, I think a half a gram is enough in a cow, orally;
11 in other words, one good dietary-supplement pill.
12 DR. McCURDY: What I am driving at is the question
13 we are asked is really not do we wish to regulate these
14 things coming in. I think the statements about difficulties
15 in regulating things in the future or near future for new
16 regulations were probably accurate.
17 But I think that we could exhibit some quite
18 reasonable concern about blood donors who are taking dietary
19 supplements that contain a certain amount of unspecified-
20 origin brain, brain-related, brain and pituitary material.
21 If they have done this for more than a sniff or something
22 like that, then, perhaps, they should be deferred as blood
23 donors.
24 That is probably worse than spending six months in
25 the U.K.
254
1 DR. BROWN: That is exactly right. I think that
2 is why the discussion has apparently been on things that are
3 not directly related to these questions because, in order to
4 think about deferrals for blood donors who are taking
5 dietary supplements with things like bovine brain in them,
6 it is very important that we know that those products are
7 safe.
8 I think we have heard enough to suggest that they
9 may not be.
10 DR. McCURDY: There is one other item that needs
11 to be considered and that is what proportion of blood donors
12 are doing this; that is, how many blood donors would you
13 lose, and I don't know what the demographics--there is
14 fairly good information on the demography of blood donors.
15 I have no idea what the demography of people who take these
16 supplements is. Maybe they are old men like me and aren't
17 going to be blood donors anymore.
18 DR. BROWN: The wording of the question is not as
19 demanding as the wording of other deferral questions; that
20 is, the question here is consider recommending. We are
21 not even recommending at this point. We are saying to the
22 FDA, please think about this. It is worth thinking about.
23 DR. DETWILER: One point about brain from Europe,
24 and Jean Philippe is still here, those are considered
25 specified risk material and it is not correct to be
255
1 incinerated; correct? Or destroyed? Brain and spinal cord
2 and other high-risk tissues in Europe?
3 DR. NORTON: In tomorrow morning's British Medical
4 Journal, which has appeared on-line today, there is an
5 article called U.S. Takes Precautions against BSE. One
6 paragraph says, Even though the U.S. and U.K. governments
7 ban the practice of feeding cattle products to cows, in the
8 early 1990s, some U.K. renderers continued to manufacture
9 and ship contaminated meat and bonemeal around the world.
10 British export statistics show that thirty-seven tons of
11 meal made from offal was sent to the United States in 1997,
12 well after the U.S. government banned imports of such risky
13 meat. The ultimate use of these imports has not been
14 identified.
15 That will appear tomorrow morning.
16 DR. DETWILER: That actually was in The New York
17 Times. That is a direct quote out of The New York Times
18 article. We called the reporter on that. That statement,
19 the thirty-seven tons, was taken out of the U.S.
20 Geographical BSE Risk Assessment. What they didn't put in
21 there, in the statement, was the remainder of the GBR is at
22 that time, the big labeling for that category in the U.K.,
23 because it was illegal for them to ship it to us from their
24 own regs. It is illegal for us to get that.
25 We did go and try and trace that so that wasn't [FULL TEXT ABOUT 600 PAGES]
3681t2.rtf
http://www.fda.gov/ohrms/dockets/ac/cber01.htm
http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm
IN fact, we are now finding that as little as 1 mg (or 0.001 gm) caused 7% (1 of 14) of the cows to come down with BSE ;
Published online
January 27, 2005
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
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 ef.ciency 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 .ndings 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.
snip...
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 .rst 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
snip...end
www.thelancet.com Published online January 27, 2005
THEN you must consider cross contamination at feed mills and such. this has been well proven in both the UK and the USA to date via r-to-r feed ban violations. IT was proven in the UK that they indeed put profits before human health;
[PDF] The BSE Inquiry / Statement No. 14 Issued 20 March 1998 THE ...
The BSE Inquiry / Statement No. 14. Issued 20 March 1998 ... number of feed compounders and it became clear that cross contamination of feeds could occur. ...
http://www.bseinquiry.gov.uk/files/ws/s014.pdf
[PDF] The BSE Inquiry / Statement No 76F (Supplementary) Mr Alan ...
But the mainbut the main problem was probably cross-contamination. ...
http://www.bseinquiry.gov.uk/files/ws/s076f.pdf
STRICTLY PRIVATE AND CONFIDENTIAL 25, AUGUST 1995
snip...
To minimise the risk of farmers' claims for compensation from feed compounders.
To minimise the potential damage to compound feed markets through adverse publicity.
To maximise freedom of action for feed compounders, notably by maintaining the availability of meat and bone meal as a raw material in animal feeds, and ensuring time is available to make any changes which may be required.
snip...
THE FUTURE
4..........
MAFF remains under pressure in Brussels and is not skilled at handling potentially explosive issues.
5. Tests _may_ show that ruminant feeds have been sold which contain illegal traces of ruminant protein. More likely, a few positive test results will turn up but proof that a particular feed mill knowingly supplied it to a particular farm will be difficult if not impossible.
6. The threat remains real and it will be some years before feed compounders are free of it. The longer we can avoid any direct linkage between feed milling _practices_ and actual BSE cases, the more likely it is that serious damage can be avoided. ...
SEE full text ;
http://www.bseinquiry.gov.uk/files/yb/1995/08/24002001.pdf
snip...
From: TSS () Subject: Inspector to file charges against USDA for them charging him with misconduct on telling the truth about SRM mad cow violations Date: September 7, 2005 at 1:37 pm PST
Consumer Health
Inspector to file charges against USDA By Steve Mitchell Sep 6, 2005, 22:46 GMT
WASHINGTON, DC, United States (UPI) -- The federal meat inspector who was charged with misconduct by the U.S. Department of Agriculture after he claimed mad cow disease safeguards were being violated at slaughterhouses told United Press International he plans to file charges against the agency.
Stan Painter, a USDA inspector and chair of the National Joint Council of Food Inspection Locals, the inspectors union, notified the agency`s management in a letter last December he was aware of instances where the riskiest parts of older cows were not being marked or removed from processing.
Painter worried these risky parts -- known as specified risk materials, or SRMs -- could enter the food supply and infect people, causing a fatal brain illness called variant Creutzfeldt Jakob disease.
Two cases of mad cow have been detected in U.S. herds, and some suspect there are more. The USDA put the SRM safeguards in place in 2004 to protect the public from mad cow disease -- also known as bovine spongiform encephalopathy or BSE -- if more cases are detected.
The USDA did not respond to Painter`s concerns until he made his letter known to news outlets.
On Dec. 28, 2004, the agency charged Painter with personal misconduct for not revealing the names of the inspectors who told him of the SRM violations. Officials also told him he was under a formal investigation, which was dropped last month after the release of internal documents revealing more than 1,000 violations of the USDA`s SRM regulations.
Painter said he thinks the USDA was attempting 'to harass and intimidate him (and) to have a chilling effect' on other inspectors.
'I plan to file charges against the agency,' he told UPI, adding he has not yet decided if he will go through the legal system, through internal USDA procedures or another avenue.
Asked about Painter`s intent to bring charges, agency spokesman Steven Cohen told UPI the documents -- called noncompliance reports, or NRs -- demonstrate 'that BSE safeguard regulations are being enforced and prohibited materials did not reach the public.'
Mad cow disease remains a sensitive topic for the USDA because it can have significant economic ramifications. The U.S. beef industry lost billions of dollars because more than 60 nations closed their borders in 2003 to American beef after the report of the first detected case in U.S. herds. Japan, formerly the largest importer of American beef, still has not reopened its borders.
For months, USDA officials denied Painter`s allegations in media reports, saying they had investigated and found no evidence to substantiate his claims. The NRs released last month under the Freedom of Information Act, however, showed 1,036 violations of SRM regulations in at least 35 states, Puerto Rico and the Virgin Islands, with some plants being cited repeatedly for infractions. The USDA delayed releasing the documents for eight months despite a federal law mandating a response within 30 days.
Patty Lovera, of the watchdog group Public Citizen, which requested the USDA documents, said some of the violations cited in the NRs are egregious. In one, an employee at a plant in Michigan was not properly marking older cows to have their SRMs removed because he did not have a pencil. In another, an employee in a Missouri plant was loading cow heads onto his pickup truck to take home to feed to his dog.
Lovera charged the USDA with attempting to silence Painter and failing to address problems with the SRM ban.
'Their behavior through this whole thing is appalling,' she told UPI. 'Stan brought them concerns about a policy and instead of investigating the policy, they investigated him.'
Last December, after Painter made his letter known publicly, the USDA sent an officer to Painter`s house while he was on leave to question him about the allegations in his letter. Later, USDA officials interrogated Painter twice, asking him for the names of the inspectors who told him about the violations.
Painter said he intentionally was kept ignorant of the inspectors` names because he feared the agency would retaliate against them. Painter also said USDA officials did not need the inspectors` names because they could determine where the infractions were occurring by looking at their database of NRs.
Sometime around June the U.S. Embassy in Japan posted a notice on its Web site stating USDA officials had found no evidence to substantiate Painter`s claims and had requested a criminal investigation into his actions. The notice was removed in July after UPI reported its existence.
Although Cohen acknowledged more than 1,000 NRs were written by USDA inspectors, he minimized their significance, saying they 'amount to less than one-half of one percent of the total written for all reasons by (USDA) inspection program personnel.'
Lovera said any infraction of mad cow safeguards should be of concern, because this disease always is fatal in humans and cooking does not destroy the pathogen.
'You have very little margin of error for something you don`t want to get because you can`t cook it away and you can`t disinfect it,' she said.
Painter said his concern now is what the agency will do to fix what he sees as shortcomings in the SRM policy.
'It`s a failed policy,' he said. 'It doesn`t protect the consumer.'
Cohen did not respond to whether the USDA planned to change the SRM regulations.
The USDA`s Office of Inspector General has launched an investigation to determine whether the regulations are being implemented effectively, and results are due out soon.
E-mail: sciencemail@upi.com
Copyright 2005 by United Press International
***makes no difference, GW will change the SRM rules like he has the BSE GBR risk assessment to the terribly flawed BSE MRR policy, the legal trading of all strains of TSE, the 'gold card'. ...TSS
IN a time when FDA/USDA et al should be strengthening the TSE regulations, it seems corporate interest has won out again over sound science and consumer protection from an agent that is 100% fatal for the ones that go clinical. With the many different atypical TSEs showing up in different parts of the world, and with GWs BSE MRR policy (the legal policy of trading all strains of TSEs), the battle that has waged for the last 25 years to eradicate this agent from this planet will be set back decades, if not lost for good. ...TSS
snip...
http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm
http://www.fas.usda.gov/info/fr/2004/071404BSEFDA1.htm
http://www.fda.gov/ohrms/DOCKETS/dockets/04n0081/04n-0081-ref0001-Tab-A-vol6.pdf
APHIS-2006-0041-0006 TSE advisory committee for the meeting December 15, 2006
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8
Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE)
http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf
[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
9/13/2005
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf
BSE; MRR; IMPORTATION OF LIVE BOVINES AND PRODUCTS DERIVED FROM BOVINES [Docket No. APHIS-2006-0041] RIN 0579-AC01
[Federal Register: January 9, 2007 (Volume 72, Number 5)] [Proposed Rules] [Page 1101-1129] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr09ja07-21]
http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064801f8152
BSE; MRR; IMPORTATION OF LIVE BOVINES AND PRODUCTS DERIVED FROM BOVINES [Docket No. APHIS-2006-0041] RIN 0579-AC01 Date: January 9, 2007 at 9:08 am PST
http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064801f3412
Sunday, March 16, 2008
MAD COW DISEASE terminology UK c-BSE (typical), atypical BSE H or L, and or Italian L-BASE
SCHOOL LUNCH PROGRAM FROM DOWNER CATTLE UPDATE
http://downercattle.blogspot.com/
SRM MAD COW RECALL 406 THOUSAND POUNDS CATTLE HEADS WITH TONSILS KANSAS
SPECIFIED RISK MATERIALS
*Acquired in UK ** Acquired in Saudi Arabia *** Includes 17 inconclusive and 9 pending (1 from 2006, 8 from 2007. **** Includes 17 non-vCJD type unknown (2 from 1996, 2 from 1997, 1 from 2001, 1 from 2003, 4 from 2004, 3 from 2005, 4 from 2006) and 36 type pending (2 from 2005, 8 from 2006, 26 from 2007).
Notes:
-- Cases are listed based on the year of death when available. If the year of death is not available, the year of sample receipt is used.
-- Referrals: Cases with possible or probable prion disease from which brain tissue or blood in the case of familial disease were submitted.
-- Inconclusive: Cases in which the samples were not sufficient to make a diagnosis.
-- Non-vCJD type unknown are cases in which the tissue submitted was adequate to establish the presence but not the type; in all cases, vCJD could be excluded.
-- Communicated by: Terry S. Singeltary Sr.
[In submitting these data, Terry S. Singeltary Sr. draws attention to the steady increase in the "type unknown" category, which, according to their definition, comprises cases in which vCJD could be excluded. The total of 26 cases for the current year (2007) is disturbing, possibly symptomatic of the circulation of novel agents. Characterization of these agents should be given a high priority. - Mod.CP]
http://www.promedmail.org/pls/askus/f?p=2400:1001:6833194127530602005::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1010,39963
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.
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf
ALL animals for human/animal consumption must be tested for TSE.
ALL human TSEs must be made reportable Nationally and Internationally, OF ALL AGES. ...TSS
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
COMMENT FROM TERRY SINGELTARY SR.
Other: Jarrow Formulas, Inc. (P. Scott Polisky, Esq.) - Request for Extension
Document ID: FDA-2011-D-0376-1650 Docket ID: FDA-2011-D-0376 Comment ID: FDA-2011-D-0376-1652Comment Type: Public Submission
COMMENT
Docket No. FDA-2011-D-0376 Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Revised Draft Guidance for Industry Singeltary Submission My name is Terry S. Singeltary Sr., and I would kindly like to submit my comments and my concern on Docket No. FDA-2011-D-0376 Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Revised Draft Guidance for Industry. I believe that the FDA consistently misses the ELEPHANT IN THE ROOM, when it pertains to these Nutritional Supplements, and that would be the Transmissible Spongiform Encephalopathy TSE Prion aka mad cow type disease, and tissues and organs used in some of these Nutritional Supplements. By continuing to allow _any_ type of tissue or organ of animals of any species in the manufacturing of any Nutritional supplements, especially with the atypical TSE prion disease showing up in many species, you risk humans to Creutzfeldt Jakob Disease CJD aka mad cow type disease. The FDA has been warning of this since around 2001 or sooner, voluntarily. as you can surely see, voluntary does NOT work, we all know it, all one has to do is look at the August 1997 mad cow feed ban. all the FDA is doing, and has done for decades, is allow the public that are consuming these type supplements to be exposed to the TSE PRION aka MAD COW type agent. all they can do now is wait, 10, 20, maybe 50 years, for a slow incubating TSE Prion disease, that once clinical, is 100% fatal. By continuing to ignore these risk factors, you continue to risk exposing consumers to the TSE PRION aka mad cow type disease, and you have known it for decades.
* YOU must ban all animal tissue and organs from any Nutritional Supplement.
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE
Friday, January 19, 2001
FDA TSEAC MEETING
snip...
MONDAY, JUNE 19, 2017
Transmissible Spongiform Encephalopathies Advisory Committee June 2017 CJD, BSE, Scrapie, CWD, TSE, Prion?
http://creutzfeldt-jakob-disease.blogspot.com/2017/06/transmissible-spongiform.html
http://creutzfeldt-jakob-disease.blogspot.com/2017/06/transmissible-spongiform.html
Subject: PRION 2017 CONFERENCE ABSTRACT First evidence of intracranial and peroral transmission of Chronic Wasting Disease (CWD) into Cynomolgus macaques: a work in progress
First evidence of intracranial and peroral transmission of Chronic Wasting Disease (CWD) into Cynomolgus macaques: a work in progress
Stefanie Czub1, Walter Schulz-Schaeffer2, Christiane Stahl-Hennig3, Michael Beekes4, Hermann Schaetzl5 and Dirk Motzkus6 1
University of Calgary Faculty of Veterinary Medicine/Canadian Food Inspection Agency; 2Universitatsklinikum des Saarlandes und Medizinische Fakultat der Universitat des Saarlandes; 3 Deutsches Primaten Zentrum/Goettingen; 4 Robert-Koch-Institut Berlin; 5 University of Calgary Faculty of Veterinary Medicine; 6 presently: Boehringer Ingelheim Veterinary Research Center; previously: Deutsches Primaten Zentrum/Goettingen
This is a progress report of a project which started in 2009. 21 cynomolgus macaques were challenged with characterized CWD material from white-tailed deer (WTD) or elk by intracerebral (ic), oral, and skin exposure routes. Additional blood transfusion experiments are supposed to assess the CWD contamination risk of human blood product. Challenge materials originated from symptomatic cervids for ic, skin scarification and partially per oral routes (WTD brain). Challenge material for feeding of muscle derived from preclinical WTD and from preclinical macaques for blood transfusion experiments. We have confirmed that the CWD challenge material contained at least two different CWD agents (brain material) as well as CWD prions in muscle-associated nerves.
Here we present first data on a group of animals either challenged ic with steel wires or per orally and sacrificed with incubation times ranging from 4.5 to 6.9 years at postmortem. Three animals displayed signs of mild clinical disease, including anxiety, apathy, ataxia and/or tremor. In four animals wasting was observed, two of those had confirmed diabetes. All animals have variable signs of prion neuropathology in spinal cords and brains and by supersensitive IHC, reaction was detected in spinal cord segments of all animals. Protein misfolding cyclic amplification (PMCA), real-time quaking-induced conversion (RT-QuiC) and PET-blot assays to further substantiate these findings are on the way, as well as bioassays in bank voles and transgenic mice.
At present, a total of 10 animals are sacrificed and read-outs are ongoing. Preclinical incubation of the remaining macaques covers a range from 6.4 to 7.10 years. Based on the species barrier and an incubation time of > 5 years for BSE in macaques and about 10 years for scrapie in macaques, we expected an onset of clinical disease beyond 6 years post inoculation.
PRION 2017 DECIPHERING NEURODEGENERATIVE DISORDERS
http://prion2017.org/programme/
TUESDAY, JUNE 13, 2017
PRION 2017 CONFERENCE ABSTRACT First evidence of intracranial and peroral transmission of Chronic Wasting Disease (CWD) into Cynomolgus macaques: a work in progress
http://chronic-wasting-disease.blogspot.com/2017/06/prion-2017-conference-abstract-first.html
First evidence of intracranial and peroral transmission of Chronic Wasting Disease (CWD) into Cynomolgus macaques: a work in progress
Stefanie Czub1, Walter Schulz-Schaeffer2, Christiane Stahl-Hennig3, Michael Beekes4, Hermann Schaetzl5 and Dirk Motzkus6 1
University of Calgary Faculty of Veterinary Medicine/Canadian Food Inspection Agency; 2Universitatsklinikum des Saarlandes und Medizinische Fakultat der Universitat des Saarlandes; 3 Deutsches Primaten Zentrum/Goettingen; 4 Robert-Koch-Institut Berlin; 5 University of Calgary Faculty of Veterinary Medicine; 6 presently: Boehringer Ingelheim Veterinary Research Center; previously: Deutsches Primaten Zentrum/Goettingen
This is a progress report of a project which started in 2009. 21 cynomolgus macaques were challenged with characterized CWD material from white-tailed deer (WTD) or elk by intracerebral (ic), oral, and skin exposure routes. Additional blood transfusion experiments are supposed to assess the CWD contamination risk of human blood product. Challenge materials originated from symptomatic cervids for ic, skin scarification and partially per oral routes (WTD brain). Challenge material for feeding of muscle derived from preclinical WTD and from preclinical macaques for blood transfusion experiments. We have confirmed that the CWD challenge material contained at least two different CWD agents (brain material) as well as CWD prions in muscle-associated nerves.
Here we present first data on a group of animals either challenged ic with steel wires or per orally and sacrificed with incubation times ranging from 4.5 to 6.9 years at postmortem. Three animals displayed signs of mild clinical disease, including anxiety, apathy, ataxia and/or tremor. In four animals wasting was observed, two of those had confirmed diabetes. All animals have variable signs of prion neuropathology in spinal cords and brains and by supersensitive IHC, reaction was detected in spinal cord segments of all animals. Protein misfolding cyclic amplification (PMCA), real-time quaking-induced conversion (RT-QuiC) and PET-blot assays to further substantiate these findings are on the way, as well as bioassays in bank voles and transgenic mice.
At present, a total of 10 animals are sacrificed and read-outs are ongoing. Preclinical incubation of the remaining macaques covers a range from 6.4 to 7.10 years. Based on the species barrier and an incubation time of > 5 years for BSE in macaques and about 10 years for scrapie in macaques, we expected an onset of clinical disease beyond 6 years post inoculation.
PRION 2017 DECIPHERING NEURODEGENERATIVE DISORDERS
http://prion2017.org/programme/
TUESDAY, JUNE 13, 2017
PRION 2017 CONFERENCE ABSTRACT First evidence of intracranial and peroral transmission of Chronic Wasting Disease (CWD) into Cynomolgus macaques: a work in progress
http://chronic-wasting-disease.blogspot.com/2017/06/prion-2017-conference-abstract-first.html
TUESDAY, JUNE 20, 2017
*** Prion 2017 Conference Transmissible prions in the skin of Creutzfeldt-Jakob disease patients
Wednesday, May 24, 2017
PRION2017 CONFERENCE VIDEO UPDATE 23 – 26 May 2017 Edinburgh UPDATE 1
Subject: PRION2017 CONFERENCE VIDEO UPDATE 23 – 26 May 2017 Edinburgh
*see archives of previous Prion Conferences, the ones that are still available, scroll down towards bottom in this link.
MONDAY, JUNE 19, 2017
PRION 2017 P20 Descriptive epidemiology of human prion diseases in Japan: a prospective 16-year surveillance study
Japan Prion Disease Increasing Annually to 2.3 patients per 1 million populations in 2014
FRIDAY, JUNE 16, 2017
PRION 2017 P55 Susceptibility of human prion protein to in vitro conversion by chronic wasting disease prions
FRIDAY, JUNE 16, 2017
P55 Susceptibility of human prion protein to in vitro conversion by chronic wasting disease prions
TUESDAY, JUNE 13, 2017
PRION 2017 CONFERENCE ABSTRACT Chronic Wasting Disease in European moose is associated with PrPSc features different from North American CWD
TUESDAY, JUNE 13, 2017
PRION 2017 CONFERENCE ABSTRACT Chronic Wasting Disease in European moose is associated with PrPSc features different from North American CWD
Saturday, June 17, 2017
PRION 2017 P115 α- Synuclein prions from MSA patients exhibit similar transmission properties as PrPSc prions
SATURDAY, JUNE 10, 2017
Chronic Wasting Disease CWD TSE Prion to Humans, who makes that final call, when, or, has it already happened?
TUESDAY, APRIL 18, 2017
*** EXTREME USA FDA PART 589 TSE PRION FEED LOOP HOLE STILL EXIST, AND PRICE OF POKER GOES UP ***
Terry S. Singeltary Sr.
Bacliff, Texas USA 77518
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