Creutzfeldt Jakob Disease TSE Prion and Nutritional Supplements, Porcine Products, what you need to know

***> FDA DOES NOT have mandatory established specifications for animal-derived ingredients to ensure they are BSE free in Nutritional Supplements

Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle

Created by the Food and Drug Administration

PUBLIC SUBMISSION

Comment from Terry Singeltary

Posted by the Food and Drug Administration on Jun 25, 2017

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...

FDA DOES NOT have mandatory established specifications for animal-derived ingredients to ensure they are BSE free in Nutritional Supplements

Thank You, I am sincerely,

Terry S. Singeltary Sr.

please see ;

SOURCE REFERENCES in PDF FILE UPLOAD

https://beta.regulations.gov/document/FDA-2009-N-0505-0010

https://downloads.regulations.gov/FDA-2009-N-0505-0010/attachment_1.pdf

http://animalhealthreportpriontse.blogspot.com/2017/06/docket-no-fda-2009n0505-agency.html

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 17-04

Published Date: 12/10/2020

Type: DWP

HIGH-RISK BOVINE TISSUE AND TISSUE-DERIVED INGREDIENTS

Adrenal gland

Bone marrow

Brain

Brain extract

Cerebellum

Cerebrospinal fluid

Cranial nerves

Colon (proximal and distal)

Dura mater

Eye

Hypothalamus

Ileum

Lymph nodes

Nasal mucosa

Olfactory bulb or gland

Pineal gland

Pituitary gland

Placenta

Spinal cord

Spleen

Suprarenal gland

Tonsil Attachment B

snip...

https://www.accessdata.fda.gov/cms_ia/importalert_53.html

August 17, 1994

Food and Drug Administration

Rockville, MD 20857

To Manufacturers and Importers of Dietary Supplements:

To Manufacturers and Importers of Cosmetics:

The Food and Drug Administration (FDA) is recommending that firms that

manufacture or import dietary supplements and cosmetics containing specific

bovine tissues (see Appendix A) ensure that such tissues do not come from

cattle born, raised, or slaughtered in countries where bovine spongiform

encephalopathy (BSE) exists (BSE-countries). Extracts of these tissues and

ingredients derived from these tissues are also of concern. The recommended

actions are precautionary measures to reduce potential risk of human exposure

to, or transmission of, the agent which causes BSE in cattle.

At this time, FDA is not extending the recommendation in this

letter to dairy products or gelatin, because available evidence

does not suggest transmission via these foods. Furthermore, meat

(i.e., skeletal muscle) is not covered by this letter. For

guidance on importation of meat and other products regulated by

the United States Department of Agriculture (USDA), refer to Title 9 of the

Code of Federal Regulations.

The Agency is providing the following information to explain why

it believes that BSE may potentially be a concern with certain

dietary supplements and cosmetic products. BSE has been identified in more

than 100,000 cattle in the United Kingdom and, to a much lesser extent, in

several other countries. This neurological disease is a transmissible

spongiform encephalopathy (TSE) and is similar to other TSEs such as scrapie

in sheep and Creutzfeldt-Jakob Disease (CJD) in humans. The spongiform

encephalopathies are uniformly fatal and no rapid diagnostic test for

infection in living animals or humans is presently available. Current

scientific information indicates that the causative agent is extremely

resistant to inactivation by normal disinfection or sterilization procedures.

A range of research projects into the exact nature of both the BSE agent and

other TSE agents, host range, patterns of pathogenicity, and development of

rapid ante mortem diagnostic tests is ongoing.

Since 1991, USDA has prohibited the importation into the U.S. of

certain tissues and organs from ruminants from countries where BSE exists

(BSE-countries; see 9 CFR 94.18). USDA's regulations are intended to protect

livestock in the United States from

contracting TSEs and address known or strongly suspected modes of

transmission. For the up-to-date listing of BSE-countries please

contact USDA, Animal and Plant Health Inspection Service (APHIS)

at (301) 436-7830.

The USDA regulations permit, under certain conditions, the

importation of some cosmetic ingredients (i.e., collagen, collagen products,

amniotic liquids or extracts, placental liquids or extracts, serum albumin,

and serocolostrum) derived from ruminants from BSE-countries; see 9 CFR 95.4.

The USDA regulations do not apply to imports of:

cosmetic products that are packaged and ready for sale;

bovine-derived materials intended for human consumption

as either finished dietary supplement products or for use as

ingredients in dietary supplements; or

human food (except meat, i.e., skeletal muscle).

While documented transmission of the causative agents of BSE or

scrapie to humans has not been reported to date, the FDA wrote to

manufacturers of dietary supplements in November 1992, alerting

them to the developing concern about TSEs in animals and CJD in

man. That letter recommended that manufacturers voluntarily

investigate the geographic source(s) of any bovine or ovine

material used in their products (generally neural or glandular

tissue or tissue extracts). The Agency also suggested that each

manufacturer develop a plan "to assure, with a high degree of

certainty," that such materials are not from BSE-countries, as

identified by USDA's APHIS, or from scrapie-infected sheep flocks, either

foreign or domestic.

FDA now considers further protective steps to be reasonable and is restating

and expanding its recommendation to manufacturers and importers of dietary

supplements and their ingredients, to develop plans for ensuring, with a high

degree of certainty, that specific bovine-derived materials (see Appendix A)

from BSE-countries are not being used. The Agency is also recommending that

manufacturers and importers of cosmetic products and their ingredients develop

the same type of plans. FDA is not, at this time, recommending restrictions on

the use of ovine-derived materials in the manufacture of dietary supplement

and cosmetic products and ingredients, as the epidemiological evidence now

appears convincing that scrapie is not related to TSEs in humans.

FDA believes it is prudent to expand its recommendation to

cosmetics and cosmetic ingredients because extracts of listed

tissues, e.g. sphingolipids isolated from brain tissue and

extracts of bovine placenta, are used in cosmetics. Additionally,

FDA is unaware of data demonstrating that processing techniques

used in the manufacture of cosmetics will inactivate TSE agents.

Further, little is known about the potential human risk of

transmission from topical application of cosmetics containing TSE

agents to intact, broken or abraded skin.

To assist manufacturers and importers whose products are within

the scope of this recommendation in developing their plans, the

following guidance is provided:

. To ensure that bovine-derived materials (listed in appendix A)

used in the product(s) are from non BSE-countries, identify all

countries where the animals used were born, raised or slaughtered.

The supplier of the bovine-derived materials should provide the

necessary records.

b. Maintain traceable records for each lot of bovine-derived material

and records of products containing the materials.

. Maintain records for those products manufactured at foreign sites

or by foreign manufacturers which contain bovine-derived

materials.

The Agency recommends that manufacturers and importers of dietary

supplements and cosmetic products and ingredients used in the

manufacture of these products develop their plans within the next

two months and notify the Agency, in writing, that their plans

have been developed. The designated contact is Dr. Elisa Elliot,

Science Policy Analyst, Executive Operations Staff, HFS-22, Center for Food

Safety and Applied Nutrition, FDA, 200 C Street, S.W., Washington, DC, 20204

or FAX (202) 205-5025. FDA recommends that the plans be implemented as soon

after development as possible, and be available for review by the Agency

during inspections.

The Agency is continuing to examine all available information

about TSEs and will provide additional guidance as necessary. If

you need more information please contact Dr. Elliot by telephone

at (202) 205-5140.

We appreciate your attention to and cooperation in this matter.

Sincerely,

/s/

Linda A. Suydam

Interim Deputy Commissioner for

Operations

May 9, 1996

TO MANUFACTURERS AND IMPORTERS OF DIETARY SUPPLEMENTS:

TO MANUFACTURERS AND IMPORTERS OF COSMETICS:

As the media have widely reported, the British government announced on March 20, 1996, that new information had been gathered about bovine spongiform encephalopathy (BSE) in cattle that suggests a possible relationship between BSE and ten cases of a newly identified form of Creutzfeldt-Jakob disease (CJD), a similar fatal transmissible spongiform encephalopathy (TSE) in humans. To serve our mutual interest in protecting public health, the Food and Drug Administration (FDA) believes it is prudent to reiterate concerns we have previously expressed on this issue.

BSE is a transmissible neurologic disorder of cattle and is prevalent in

certain parts of the world. This neurological disease is one of a number of transmissible spongiform encephalopathies (TSE) known and is similar to other TSEs such as scrapie in sheep and CJD in humans. It is believed that the spread of BSE in cattle in some countries, particularly Great Britain, was caused by the feeding of infected cattle and sheep tissues to cattle. While transmission of the causative agent of BSE to humans has not been definitively documented to date, inter-species transfer has been demonstrated (e.g., mice can be infected by exposure to infected bovine tissues). Recent developments

in Great Britain raise serious questions regarding potential hazards of the consumption of animal tissues containing the causative agent of BSE.

Although there is still no definitive evidence that the consumption of bovine tissues that contain the transmissible agent for BSE cause CJD in humans, FDA is concerned that appropriate measures to eliminate the use of bovine tissues from BSE-countries be instituted industry-wide.

We strongly recommend that firms manufacturing or importing dietary

supplements which contain specific bovine tissues (see appendix A), including extracts or substances derived from such tissues, take whatever steps are necessary to assure themselves and the public that such ingredients do not come from cattle born, raised, or slaughtered in countries where BSE exists.

FDA believes that immediate and concrete steps should be taken by

manufacturers to reduce the potential risk of human exposure to the infectious agent which causes BSE in cattle.

The list of countries where BSE is known to exist is maintained by the U.S. Department of Agriculture (USDA) and codified in Title 9, Code of Federal Regulations, Part 94.18. The following is the current list:

USDA LIST OF COUNTRIES WHERE BSE EXISTS

(Current as of May 1996)

Great Britain (including Northern Ireland and the Falklands)

Switzerland

France

Republic of Ireland

Oman

Portugal

A range of research projects into the exact nature of both the BSE agent and other TSE agents is ongoing. Available scientific information indicates that these agents are extremely resistant to inactivation by normal disinfection or sterilization procedures. A number of dietary supplement products use bovine-derived tissues or extracts of such tissues as ingredients. These ingredients include, for example, specific tissues and organs or their extracts (e.g., liver powder, "orchic" extracts, ovaries, eye tissue, mammary

tissue), glandular powders or extracts (e.g., adrenal gland, thyroid gland), or specific substances extracted from glands or tissues (e.g., melatonin extracted from the pineal gland).

At a future date, we will contact you with guidance on how best to provide

assurance that your products do not contain potentially BSE-infected

materials.

We appreciate your attention to and cooperation in this matter. If you need

more information, please contact Dr. Elisa Elliot by telephone at (202)

205-5140.

Sincerely yours,

/s/

Michael A. Friedman, M.D.

Deputy Commissioner for Operations

Enclosure Appendix A

List of Tissues With Suspected Infectivity

Category I (High infectivity)

o brain

o spinal cord

Category II (Medium infectivity)

o ileum

o lymph nodes

o proximal colon

o spleen

o tonsil

o dura mater

o pineal gland

o placenta

o cerebrospinal fluid

o pituitary gland

o adrenal gland

snip...

https://www.accessdata.fda.gov/cms_ia/importalert_53.html

List taken from Report of a WHO Consultation on Public Health

Issues Related to Animal and Human Spongiform Encephalopathies,

World Health Organization, Office of International Epizootics,

Geneva, Switzerland, November 12-14, 1991.

Product Description:

Bulk shipments of high-risk bovine tissues and tissue-derived ingredients (see Attachment A for a list of affected products).

Adrenal gland; Bone marrow; Brain; Brain extract; Cerebellum; Cerebrospinal fluid; Cranial nerves; Colon (proximal and distal); Dura mater; Eye; Hypothalamus; Ileum; Lymph nodes; Nasal mucosa; Olfactory bulb or gland;;Pineal gland; Pituitary gland; Placenta; Spinal cord; Spleen; Suprarenal gland; Tonsil

Charge:

As ingredients in dietary supplements, charge: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a dietary supplement and appears to be or may be otherwise unfit for food [Adulteration, Section 402(a)(3)]." "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a dietary supplement and may have been prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health [Adulteration, Section 402(a)(4)]." As ingredients in cosmetics, charge: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a cosmetic product and appears to have or may have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health [Adulteration, Section 601(c)." If final disposition of the bulk lot is undetermined, charge: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be unfit for food [Adulteration, Section 402(a)(3)]." AND "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health [Adulteration, 402(a)(4)]". Countries

snip...

https://www.accessdata.fda.gov/cms_ia/importalert_53.html

highly refined products hrp

European Union (EU) - Export requirements for highly refined products

This directive applies to food business operators manufacturing highly refined products (HRPs) such as chondroitin sulphate, hyaluronic acid, other hydrolysed cartilage products, chitosan, glucosamine, rennet, isinglass and amino acids. These HRPs are derived from bovine, sheep, goats pigs, poultry, equine and fishery products.

Eligible/ineligible product

EU certificate for highly refined products (HRPs) refers to a list of harmonized system (HS) code(s). This list is non-exhaustive. It is the responsibility of the exporter to ensure that the product being exported will be covered by the certificates issued by the Canadian Food Inspection Agency (CFIA).

Eligible

Example of highly refined products with associated HS codes on the EU certificate:
- 2833, ex 3913, 2930, ex 2932, 3507 or 3503.

Ineligible

Information not available.

Pre-export approvals by competent authority of importing country

Establishments

The highly refined products must come from an establishment licensed under the Safe Food for Canadian Regulations (SFCR).

The EU requires that HRPs originate from an establishment operating under HACCP principles (see Preventive control plan (PCP)) as stipulated in Commission Regulation (EC) No 852/2004 of the European Parliament and of the Council.

If applicable, the raw animal material used in the HRP must come from an establishment (such as: meat or fish, etc.) which is approved to export to the EU and on the list administered by the Directorate-General of Health and Food Safety (DG-SANTE). The third country lists are available on the EU website, Third Country Establishments - List per Country. Please select "Canada" to see the associated documents.

Production controls and inspection requirements

The HRPs must meet the requirements as described on the EU model certificate. The manufacturer must implement an auditable specific procedure which demonstrates that the final product meets among others the following:

The raw material used to manufacture the HRP must be food grade
The raw material of animal origin must be from animals, including feathers thereof, which have been slaughtered in a slaughterhouse and whose carcasses have been found fit for human consumption following ante-mortem and post-mortem inspection or from approved fishery products establishments
The raw material of animal origin must come from a meat or fish establishment approved for export to the EU
Human hair must not be used as a source for the manufacture of amino acids

Imported ingredients of animal origin

If imported ingredients of animal origin are used in the HRP, the competent authority of the exporting foreign country must provide support documentation attesting that the imported ingredients comply with the EU requirements.

Labelling, packaging and marking requirements

Products need to satisfy EU labelling requirements.

Export documents available upon request

The certificate model is not available in all the languages of the member states of the Union. The CFIA may add other certificate models in additional languages of the Union as required. A reasonable delay is to be expected. However, a member state could accept a certificate which is not issued in its official language. It is the responsibility of the exporter to ensure that the certificate issued meets the requirements of the border control post (BCP)/member state of destination in terms of official language.

Certificate

Official certificate for the entry into the Union for placing on the market of highly refined chondroitin sulphate, hyaluronic acid, other hydrolysed cartilage products, chitosan, glucosamine, rennet, isinglass and amino acids intended for human consumption. (CFIA/ACIA 5889)

Information required to complete EU health certificate

Part I: Details of dispatched consignments of the EU certificate should be completed by the applicant. It is strongly recommended that the exporter works closely with the importer. Please refer also to annex II in the link below regarding how to complete export certificates.

Commission implementing regulation (EU) 2019/628 of 8 April 2019 concerning model official certificates for certain animals and goods and amending Regulation (EC) No 2074/2005 and Implementing Regulation (EU) 2016/759 as regards these model certificates

Part II: Certification, must be completed by the CFIA. Each page of the certificate should be signed and stamped. The name of the certifying officer must be in capital letters.

Note:

Boxes I.21 and I.22 of the EU certificate should be left empty. This was discussed with DG-SANTE, and it was confirmed that Canada and DG-SANTE has the same understanding that boxes I.21 and I.22 should be left empty when the certificates are not generated in the Integrated Management System for Official Controls (IMSOC). According to the information we have, the Commission specifically sent a message on January 28, 2020, to all EU member states how empty boxes should be treated.

Additional information

Samples (personal or commercial) of highly refined products may be subject to the same requirements as regular shipment. It is strongly recommended that the exporter verify these requirements with his importer and / or at the EU border inspection post where the products will be shipped.

Member countries of the European Union (EU)
Please note that the EU has international agreements with some countries (example Switzerland, Norway, Iceland and Liechtenstein), which means that they implement EU veterinary legislation with regard to movement of animal products.
EU Veterinary border control posts
Regulation (EC) No 852/2004 of the European parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs.
Regulation (EC) No 853/2004 of the European parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin.
Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives
Commission implementing regulation (EU) 2019/628 of 8 April 2019 concerning model official certificates for certain animals and goods and amending Regulation (EC) No 2074/2005 and Implementing Regulation (EU) 2016/759 as regards these model certificates

Note:

Regarding the links above related to EU regulations, please ensure that you are using the most up-to-date / consolidated version. See: EUR-Lex.

https://www.inspection.gc.ca/exporting-food-plants-or-animals/food-exports/requirements/eu-highly-refined-products/eng/1610458924184/1610458924575

THURSDAY, SEPTEMBER 26, 2019

Veterinary Biologics Guideline 3.32E: Guideline for minimising the risk of introducing transmissible spongiform encephalopathy prions and other infectious agents through veterinary biologics

https://bovineprp.blogspot.com/2019/09/veterinary-biologics-guideline-332e.html

U.S.A. 50 STATE BSE MAD COW CONFERENCE CALL Jan. 9, 2001

Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001

Date: Tue, 9 Jan 2001 16:49:00 -0800

From: "Terry S. Singeltary Sr."

Reply-To: Bovine Spongiform Encephalopathy

To: BSE-L@uni-karlsruhe.de

snip...

[host Richard Barns] and now a question from Terry S. Singeltary of CJD Watch.

[TSS] yes, thank you, U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?

[no answer, you could hear in the back ground, mumbling and 'we can't. have him ask the question again.]

[host Richard] could you repeat the question?

[TSS] U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?

[not sure whom ask this] what group are you with?

[TSS] CJD Watch, my Mom died from hvCJD and we are tracking CJD world-wide.

[not sure who is speaking] could you please disconnect Mr. Singeltary

[TSS] you are not going to answer my question?

[not sure whom speaking] NO

snip...see full archive and more of this;

http://tseac.blogspot.com/2011/02/usa-50-state-bse-mad-cow-conference.html

***> 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.

***> If this biological behavior is recapitulated in the original host species, passage of the CWD agent through pigs could potentially lead to increased pathogenicity of the CWD agent in humans.

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 - Orise Fellow item Kunkle, Robert item KONDRU, NAVEEN - Iowa State University item MANNE, SIREESHA - Iowa State University item SMITH, JODI - Iowa State University item KANTHASAMY, ANUMANTHA - Iowa State University item WEST GREENLEE, M - Iowa State University 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 month challenge groups). The remaining pigs (>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 month group was positive by EIA. PrPSc was detected by QuIC in at least one of the lymphoid tissues examined in 5/6 pigs in the intracranial <6 months group, 6/7 intracranial >6 months group, 5/6 pigs in the oral <6 months group, and 4/6 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.

***> If this biological behavior is recapitulated in the original host species, passage of the CWD agent through pigs could potentially lead to increased pathogenicity of the CWD agent in humans.

https://www.ars.usda.gov/research/publications/publication/?seqNo115=337105

https://www.ars.usda.gov/research/publications/publication/?seqNo115=326166

Research Project: Pathobiology, Genetics, and Detection of Transmissible Spongiform Encephalopathies Location: Virus and Prion Research

Title: The agent of chronic wasting disease from pigs is infectious in transgenic mice expressing human PRNP

Author item MOORE, S - Orise Fellow item Kokemuller, Robyn item WEST-GREENLEE, M - Iowa State University item BALKEMA-BUSCHMANN, ANNE - Friedrich-Loeffler-institut item GROSCHUP, MARTIN - Friedrich-Loeffler-institut item Greenlee, Justin Submitted to: Prion Publication Type: Abstract Only Publication Acceptance Date: 5/10/2018 Publication Date: 5/22/2018 Citation: Moore, S.J., Kokemuller, R.D., West-Greenlee, M.H., Balkema-Buschmann, A., Groschup, M.H., Greenlee, J.J. 2018. The agent of chronic wasting disease from pigs is infectious in transgenic mice expressing human PRNP. Prion 2018, Santiago de Compostela, Spain, May 22-25, 2018. Paper No. WA15, page 44.

Interpretive Summary:

Technical Abstract: We have previously shown that the chronic wasting disease (CWD) agent from white-tailed deer can be transmitted to domestic pigs via intracranial or oral inoculation although with low attack rates and restricted PrPSc accumulation. The objective of this study was to assess the potential for cross-species transmission of pig-passaged CWD using bioassay in transgenic mice. Transgenic mice expressing human (Tg40), bovine (TgBovXV) or porcine (Tg002) PRNP were inoculated intracranially with 1% brain homogenate from a pig that had been intracranially inoculated with a pool of CWD from white-tailed deer. This pig developed neurological clinical signs, was euthanized at 64 months post-inoculation, and PrPSc was detected in the brain. Mice were monitored daily for clinical signs of disease until the end of the study. Mice were considered positive if PrPSc was detected in the brain using an enzyme immunoassay (EIA). In transgenic mice expressing porcine prion protein the average incubation period was 167 days post-inoculation (dpi) and 3/27 mice were EIA positive (attack rate = 11%). All 3 mice were found dead and clinical signs were not noted prior to death. One transgenic mouse expressing bovine prion protein was euthanized due to excessive scratching at 617 dpi and 2 mice culled at the end of the study at 700 dpi were EIA positive resulting in an overall attack rate of 3/16 (19%). None of the transgenic mice expressing human prion protein that died or were euthanized up to 769 dpi were EIA positive and at study end point at 800 dpi 2 mice had positive EIA results (overall attack rate = 2/20 = 10%). The EIA optical density (OD) readings for all positive mice were at the lower end of the reference range (positive mice range, OD = 0.266-0.438; test positive reference range, OD = 0.250-4.000). To the authors’ knowledge, cervid-derived CWD isolates have not been successfully transmitted to transgenic mice expressing human prion protein. The successful transmission of pig-passaged CWD to Tg40 mice reported here suggests that passage of the CWD agent through pigs results in a change of the transmission characteristics which reduces the transmission barrier of Tg40 mice to the CWD agent.

***> If this biological behavior is recapitulated in the original host species, passage of the CWD agent through pigs could potentially lead to increased pathogenicity of the CWD agent in humans.

https://www.ars.usda.gov/research/publications/publication/?seqNo115=353091

***> 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.

***> If this biological behavior is recapitulated in the original host species, passage of the CWD agent through pigs could potentially lead to increased pathogenicity of the CWD agent in humans.

cwd scrapie pigs oral routes

***> However, at 51 months of incubation or greater, 5 animals were positive by one or more diagnostic methods. Furthermore, positive bioassay results were obtained from all inoculated groups (oral and intracranial; market weight and end of study) suggesting that swine are potential hosts for the agent of scrapie. <***

>*** Although the current U.S. feed ban is based on keeping tissues from TSE infected cattle from contaminating animal feed, swine rations in the U.S. could contain animal derived components including materials from scrapie infected sheep and goats. These results indicating the susceptibility of pigs to sheep scrapie, coupled with the limitations of the current feed ban, indicates that a revision of the feed ban may be necessary to protect swine production and potentially human health. <***

***> 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 month group was positive by EIA. PrPSc was detected by QuIC in at least one of the lymphoid tissues examined in 5/6 pigs in the intracranial <6 months group, 6/7 intracranial >6 months group, 5/6 pigs in the oral <6 months group, and 4/6 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.

https://www.ars.usda.gov/research/publications/publication/?seqNo115=353091

https://www.ars.usda.gov/research/project/?accnNo=432011&fy=2017

https://www.ars.usda.gov/research/publications/publication/?seqNo115=337105

2020

Transmissible Spongiform Encephalopathy TSE Prion End of Year Report

CJD FOUNDATION VIRTUAL CONFERENCE CJD Foundation Research Grant Recipient Reports Panel 2 Nov 3, 2020

zoonotic potential of PMCA-adapted CWD PrP 96SS inoculum

https://youtu.be/VfazuR7cjMc?t=1992

4 different CWD strains, and these 4 strains have different potential to induce any folding of the human prion protein.

https://youtu.be/VfazuR7cjMc?t=2019

***> PIGS, WILD BOAR, CWD <***

***> POPULATIONS OF WILD BOARS IN THE UNITED STATES INCREASING SUPSTANTUALLY AND IN MANY AREAS WE CAN SEE A HIGH DENSITY OF WILD BOARS AND HIGH INCIDENT OF CHRONIC WASTING DISEASE

HYPOTHOSIS AND SPECIFIC AIMS

HYPOTHOSIS

BSE, SCRAPIE, AND CWD, EXPOSED DOMESTIC PIGS ACCUMULATE DIFFERENT QUANTITIES AND STRAINS OF PRIONS IN PERIPHERAL TISSUES, EACH ONE OF THEM WITH PARTICULAR ZOONOTIC POTENTIALS

https://youtu.be/VfazuR7cjMc

Final Report – CJD Foundation Grant Program A.

Project Title: Systematic evaluation of the zoonotic potential of different CWD isolates. Principal Investigator: Rodrigo Morales, PhD.

https://cjdfoundation.org/sites/default/files/grant-downloads/Final%20Report%20-%20CJD%20Foundation%20-%20Morales.pdf

Systematic evaluation of the zoonotic potential of different CWD isolates. Rodrigo Morales, PhD Assistant Professor Protein Misfolding Disorders lab Mitchell Center for Alzheimer’s disease and Related Brain Disorders Department of Neurology University of Texas Health Science Center at Houston Washington DC. July 14th, 2018

Conclusions and Future Directions • We have developed a highly sensitive and specific CWD-PMCA platform to be used as a diagnostic tool. • Current PMCA set up allow us to mimic relevant prion inter-species transmission events. • Polymorphic changes at position 96 of the prion protein apparently alter strain properties and, consequently, the zoonotic potential of CWD isolates. • Inter-species and inter-polymorphic PrPC → PrPSc conversions further increase the spectrum of CWD isolates possibly present in nature. • CWD prions generated in 96SS PrPC substrate apparently have greater inter-species transmission potentials. • Future experiments will explore the zoonotic potential of CWD prions along different adaptation scenarios, including inter-species and inter-polymorphic.

https://cjdfoundation.org/files/Conf2018/Rodrigo%20Morales%202018.pdf

https://www.youtube.com/watch?v=CzQKemJRBlE&list=PLGXRDfDPg57yTYvn6tifH13NrSiLjv1d7&index=7&t=0s

Armour Thyroid (thyroid desiccated)

Armour® Thyroid (thyroid)

extraneous constituents. There is no well-documented evidence from the literature, however, of true allergic or idiosyncratic reactions to thyroid hormone.

WARNINGS

SPL UNCLASSIFIED SECTION

The use of thyroid hormones in the therapy of obesity, alone or combined with other drugs, is unjustified and has been shown to be ineffective. Neither is their use justified for the treatment of male or female infertility unless this condition is accompanied by hypothyroidism.

The active ingredient (desiccated natural thyroid) in Armour Thyroid (thyroid tablets, USP) is derived from porcine (pig) thyroid glands of pigs processed for human food consumption and is produced at a facility that also handles bovine (cow) tissues from animals processed for human food consumption. As a result, a potential risk of product contamination with porcine and bovine viral or other adventitious agents cannot be ruled out. Forest is not aware of any cases of disease transmission associated with the use of Armour Thyroid (thyroid tablets, USP).

https://phact-mi.secure.force.com/ProductMi?setid=56b41079-60db-4256-9695-202b3a65d13d&id=a00o000000fHtAC

FDA alerts drug makers of a recall of porcine thyroid API from Sichuan Friendly Pharmaceutical Co., Limited, China

[8/17/2018] FDA is alerting active pharmaceutical ingredient (API) repackagers and distributors, finished drug manufacturers, and compounders that Sichuan Friendly Pharmaceutical Co. Limited, China, is recalling certain lots of porcine thyroid API due to inconsistent quality of the API. FDA recommends that manufacturers and compounders not use Sichuan Friendly’s porcine thyroid API received since August 2015. This thyroid API comes from porcine (pig) thyroid glands and is used to make a non-FDA approved drug product, composed of levothyroxine and liothyronine, to treat hypothyroidism (underactive thyroid).

https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-drug-makers-recall-porcine-thyroid-api-sichuan-friendly-pharmaceutical-co-limited-china

DESCRIPTION

Armour® Thyroid (thyroid tablets, USP)* for oral use is a natural preparation derived from porcine thyroid glands and has a strong, characteristic odor. (T3 liothyronine is approximately four times as potent as T4 levothyroxine on a microgram for microgram basis.) They provide 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are calcium stearate, dextrose, microcrystalline cellulose, sodium starch glycolate and opadry white.

https://www.rxlist.com/armour-thyroid-drug.htm

https://www.drugs.com/pro/armour-thyroid.html

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration [Docket No. FDA–2009–N–0505]

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:

snip...

https://www.gpo.gov/fdsys/pkg/FR-2017-06-15/pdf/2017-12448.pdf

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

''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:

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

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm562515.htm

***> 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.

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

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm529991.htm

*** 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:

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.

https://www.ars.usda.gov/research/publications/publication/?seqNo115=337105

Docket No. FDA– 2009–N–0505

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration [Docket No. FDA–2009–N–0505]

AGENCY: Food and Drug Administration, HHS. ACTION: Notice.

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

https://www.gpo.gov/fdsys/pkg/FR-2017-06-15/pdf/2017-12448.pdf

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

''We offer the following comments:

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:

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.

We offer the following comments:

Sincerely,

/S/

Evelyn Bonnin

Program Division Director

HAF Division 2 E

2017

Page Last Updated: 06/12/2017

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm562515.htm

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:

Unapproved New Drugs/Misbranded Drugs

Examples of some of the claims that provide evidence that your products are intended for use as drugs include:

Chaga

Website:

Eye Health

Website:

“[S]upports eye conditions such as Cataract, Glaucoma, age related Macular Degeneration, dry eyes . . .”

Hepatocel Plus

Website:

Pamphlet:

Reishi

Pamphlet:

“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:

Healthy Joint

Website:

Pamphlet:

Horny Goat Weed

Pamphlet:

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 . . .”

Dietary Supplement CGMP Violations

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)];

Once you have established the required specifications, you must verify that the specifications are met, in accordance with 21 CFR 111.73.

a. Healthy Vision, Lot # 5120

b. Cordyceps Sinensis, Lot # 7177

c. Red Cordyceps Extract, Lot # 6204 and 6205

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)];

e. A description of packaging [21 CFR 111.210(g)]; and

Adulterated Dietary Supplement

Misbranded Dietary Supplements

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.

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.

We offer the following comments:

Sincerely,

/S/

Miriam R. Burbach

District Director

cc: Washington State Department of Agriculture

Food Safety Program

P.O. Box 42560

Olympia, Washington 98504-2560

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm529991.htm

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:

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.

Furthermore, lymphoid tissues from CWD-infected pigs could present a potential source of CWD infectivity in the animal and human food chains.

https://www.ars.usda.gov/research/publications/publication/?seqNo115=337105

MONDAY, JUNE 19, 2017

FDA DOES NOT have mandatory established specifications for animal-derived ingredients to ensure they are BSE free in Nutritional Supplements

http://creutzfeldt-jakob-disease.blogspot.com/2017/06/fda-does-not-have-mandatory-established.html

----- 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

http://europa.eu.int/comm/food/fs/sc/ssc/out296_en.pdf

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). ...

http://www.food.gov.uk/multimedia/pdfs/annualresearchrpt04.pdf

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

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 ; http://www.bse.org.uk.

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

WEDNESDAY, JUNE 21, 2017

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

http://animalhealthreportpriontse.blogspot.com/2017/06/docket-no-fda-2009n0505-agency.html

New Warning About Supplement Sources

By Melissa Schorr January 6, 2006, 7:50 AM • 6 min read B O S T O N, July 26, 2000 -- Dietary supplements, used by almost half of all Americans, often contain raw animal products that may be contaminated with mad cow disease, due to lack of federal oversight, says a Maryland doctor.

Dr. Scott Norton, a Chevy Chase, Md.,-based dermatologist, says he discovered the disturbing news when he took his sons to the local health food store for an “indoor safari ” after their nature hike was rained out. But instead of finding natural herbs and plants on the labels, to his dismay, the former botanist discovered they contained raw animal meats, such as cow thymus, liver and brain.

This finding led Norton to question the source — and safety, in this era of mad cow disease — of the contents of dietary supplements, which industry watchdogs say are largely unregulated by the Food and Drug Administration.

“I was appalled,” Norton says. “If I were given the opportunity to eat brain tissue from an unidentified animal, for an unidentified location, I would decline — and recommend that my family and patients decline, too.”

Norton wrote a letter to the New England Journal of Medicine that was published today sounding the alarm to doctors and consumers.

“We thought the author made some interesting points that ought to be of concern to people who take these products,” says Dr. Robert Utiger, the journal’s deputy editor, who decided to print the striking letter.

No Oversight in Sight Norton points out that although there have been no documented cases of any transmission of bovine spongiform encephalopathy — known as mad cow disease — through dietary supplements, without adequate governmental oversight, the possibility exists.

And several pharmacologists say they don’t find the idea as outlandish as one might think.

“I believe that Dr. Norton has articulated a reasonable concern,” says Jan Engle, professor of pharmacy at the University of Illinois in Chicago. “There is a theoretical risk.”

Bovine Brains Mad cow disease, which has caused the death of more than 50 people in Britian, is thought to be caused by prions, which are unidentified infectious agents that eat away at brain tissue. No cases have been documented in the U.S., largely because the FDA and the U.S. Department of Agriculture have banned the import of beef from affected countries.

But because the FDA doesn’t regulate what goes into dietary supplements, there is no way of assuring that infected meat from overseas is not being used.

“The origin of these products is not controlled,” says Dr. Domenic Sica, professor of medicine and pharmacology at the Medical College of Virginia in Richmond. “Some of this stuff has raw materials imported from outside the U.S. It’s not safe just because a company says it’s safe.”

“There’s so many ways that there are holes,” agrees Dr. Randy Juhl, dean of the school of pharmacy at the University of Pittsburgh. “Such as, if the supplement is imported from another country. And who is looking to see where the dead cows came from? This points out yet another hole in our regulation of dietary supplements.”

Supplements Unsupervised That hole, experts say, has been caused by a 1994 act of Congress that left dietary supplements largely unregulated before they go on the market.

“Companies don’t have to do safety tests,” explains David Schardt, an associate nutritionist with the Center for Science in the Public Interest, a consumer watchdog group based in Washington, D.C. “They’re not allowed to sell products they know are unsafe, but the FDA has to prove they’re unsafe before can pull off. The FDA has the burden of proof.”

“This is another example of the dietary industry selling protects that have potential health risks and eluding safety monitoring,” Norton says. “The industry needs some regulation.” The FDA was preparing a statement in response to the letter at press time.

But so far, the agency has only been concerned with keeping regulated drugs and medical products free of the disease, says Paul Brown, senior scientist at the National Institutes of Health and chairman of the committee monitoring the transmission of transmissible spongiform encephalopathy.

“I would look forward for this issue to be the subject of a meeting for public discussion,” Brown says. “Some of these supplements do use powdered bovine brain. I guarantee you if you used an animal with mad cow disease, it would be infectious.”

Prions Prevailing There is a risk that prions could remain even in supplements that have been processed because they are harder to kill than bacteria and viruses, explains Caroline Smith DeWalle, director of food safety of the Center for Science in the Public Interest.

“We don’t know how to clean up the products to prevent the transmission of mad cow disease,” she says. “There is no safe way to assure the products of these animals aren’t affected.”

But testing these dietary supplements for presence of the disease would be “horrendously expensive” and would not able to pick up the minute traces, anyway, the NIH’s Brown says.

Supplements are ‘Safe’ The letter “falsely impugns the safety of glandular products marketed in the U.S.,” says John Cordaro, president of the Council For Responsible Nutrition, a dietary supplement industry group. “Consumers who value these products can use them in confidence,” he says, because the FDA's “import alert” monitors shipments of cattle products from affected countries and would consider them to be “adulterated.” Only a “tiny proportion” contain glandular ingredients from cows, he adds, and those that do usually come from herds in the U.S.

Indeed, companies like Standard Process, a 70-year old supplement manufacturer based in Palmyra, Wis., which uses cow brains, spleens and livers in some of its products, notes on its Web site that bovine organs come from USDA-inspected facilities, and only from within the United States.

But experts agree there is always a risk of companies either unknowingly or unscrupulously obtaining contaminated cow material.

“I hope these companies are using their heads,” the NIH’s Brown says, “and not the cattle’s heads.”

https://abcnews.go.com/Health/story?id=118112&page=1

TSE PRION ZOONOSIS ZOONOTIC UPDATE

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.

==============

https://prion2015.files.wordpress.com/2015/05/prion2015abstracts.pdf

***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.

http://www.tandfonline.com/doi/abs/10.1080/19336896.2016.1163048?journalCode=kprn20

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

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.

http://www.tandfonline.com/doi/abs/10.1080/19336896.2016.1163048?journalCode=kprn20

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.

http://www.ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=313160

1: J Infect Dis 1980 Aug;142(2):205-8

Oral transmission of kuru, Creutzfeldt-Jakob disease, and scrapie to nonhuman primates.

Gibbs CJ Jr, Amyx HL, Bacote A, Masters CL, Gajdusek DC.

Kuru and Creutzfeldt-Jakob disease of humans and scrapie disease of sheep and goats were transmitted to squirrel monkeys (Saimiri sciureus) that were exposed to the infectious agents only by their nonforced consumption of known infectious tissues. The asymptomatic incubation period in the one monkey exposed to the virus of kuru was 36 months; that in the two monkeys exposed to the virus of Creutzfeldt-Jakob disease was 23 and 27 months, respectively; and that in the two monkeys exposed to the virus of scrapie was 25 and 32 months, respectively. Careful physical examination of the buccal cavities of all of the monkeys failed to reveal signs or oral lesions. One additional monkey similarly exposed to kuru has remained asymptomatic during the 39 months that it has been under observation.

snip...

The successful transmission of kuru, Creutzfeldt-Jakob disease, and scrapie by natural feeding to squirrel monkeys that we have reported provides further grounds for concern that scrapie-infected meat may occasionally give rise in humans to Creutzfeldt-Jakob disease.

PMID: 6997404

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=6997404&dopt=Abstract

Recently the question has again been brought up as to whether scrapie is transmissible to man. This has followed reports that the disease has been transmitted to primates. One particularly lurid speculation (Gajdusek 1977) conjectures that the agents of scrapie, kuru, Creutzfeldt-Jakob disease and transmissible encephalopathy of mink are varieties of a single "virus". The U.S. Department of Agriculture concluded that it could "no longer justify or permit scrapie-blood line and scrapie-exposed sheep and goats to be processed for human or animal food at slaughter or rendering plants" (ARC 84/77)" The problem is emphasised by the finding that some strains of scrapie produce lesions identical to the once which characterise the human dementias"

Whether true or not. the hypothesis that these agents might be transmissible to man raises two considerations. First, the safety of laboratory personnel requires prompt attention. Second, action such as the "scorched meat" policy of USDA makes the solution of the acrapie problem urgent if the sheep industry is not to suffer grievously.

snip...

76/10.12/4.6

http://web.archive.org/web/20010305223125/www.bseinquiry.gov.uk/files/yb/1976/10/12004001.pdf

Nature. 1972 Mar 10;236(5341):73-4.

Transmission of scrapie to the cynomolgus monkey (Macaca fascicularis).

Gibbs CJ Jr, Gajdusek DC.

Nature 236, 73 - 74 (10 March 1972); doi:10.1038/236073a0

Transmission of Scrapie to the Cynomolgus Monkey (Macaca fascicularis)

C. J. GIBBS jun. & D. C. GAJDUSEK

National Institute of Neurological Diseases and Stroke, National Institutes of Health, Bethesda, Maryland

SCRAPIE has been transmitted to the cynomolgus, or crab-eating, monkey (Macaca fascicularis) with an incubation period of more than 5 yr from the time of intracerebral inoculation of scrapie-infected mouse brain. The animal developed a chronic central nervous system degeneration, with ataxia, tremor and myoclonus with associated severe scrapie-like pathology of intensive astroglial hypertrophy and proliferation, neuronal vacuolation and status spongiosus of grey matter. The strain of scrapie virus used was the eighth passage in Swiss mice (NIH) of a Compton strain of scrapie obtained as ninth intracerebral passage of the agent in goat brain, from Dr R. L. Chandler (ARC, Compton, Berkshire).

http://www.nature.com/nature/journal/v236/n5341/abs/236073a0.html

http://scrapie-usa.blogspot.com/2010/04/scrapie-and-atypical-scrapie.html

Wednesday, February 16, 2011

IN CONFIDENCE

SCRAPIE TRANSMISSION TO CHIMPANZEES

IN CONFIDENCE

http://scrapie-usa.blogspot.com/2011/02/in-confidence-scrapie-transmission-to.html

> However, to date, no CWD infections have been reported in people.

key word here is ‘reported’. science has shown that CWD in humans will look like sporadic CJD. SO, how can one assume that CWD has not already transmitted to humans? they can’t, and it’s as simple as that. from all recorded science to date, CWD has already transmitted to humans, and it’s being misdiagnosed as sporadic CJD. …terry

*** 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).***

http://www.tandfonline.com/doi/full/10.4161/pri.28124?src=recsys

http://www.tandfonline.com/doi/pdf/10.4161/pri.28124?needAccess=true

https://wwwnc.cdc.gov/eid/article/20/1/13-0858_article

Chronic Wasting Disease CWD TSE Prion aka mad deer disease zoonosis

We hypothesize that:

(1) The classic CWD prion strain can infect humans at low levels in the brain and peripheral lymphoid tissues;

(2) The cervid-to-human transmission barrier is dependent on the cervid prion strain and influenced by the host (human) prion protein (PrP) primary sequence;

(3) Reliable essays can be established to detect CWD infection in humans; and

(4) CWD transmission to humans has already occurred. We will test these hypotheses in 4 Aims using transgenic (Tg) mouse models and complementary in vitro approaches.

http://grantome.com/grant/NIH/R01-NS088604-04

ZOONOTIC CHRONIC WASTING DISEASE CWD TSE PRION UPDATE

Prion 2017 Conference

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

PRION 2018 CONFERENCE

Oral transmission of CWD into Cynomolgus macaques: signs of atypical disease, prion conversion and infectivity in macaques and bio-assayed transgenic mice

Hermann M. Schatzl, Samia Hannaoui, Yo-Ching Cheng, Sabine Gilch (Calgary Prion Research Unit, University of Calgary, Calgary, Canada) Michael Beekes (RKI Berlin), Walter Schulz-Schaeffer (University of Homburg/Saar, Germany), Christiane Stahl-Hennig (German Primate Center) & Stefanie Czub (CFIA Lethbridge).

To date, BSE is the only example of interspecies transmission of an animal prion disease into humans. The potential zoonotic transmission of CWD is an alarming issue and was addressed by many groups using a variety of in vitro and in vivo experimental systems. Evidence from these studies indicated a substantial, if not absolute, species barrier, aligning with the absence of epidemiological evidence suggesting transmission into humans. Studies in non-human primates were not conclusive so far, with oral transmission into new-world monkeys and no transmission into old-world monkeys. Our consortium has challenged 18 Cynomolgus macaques with characterized CWD material, focusing on oral transmission with muscle tissue. Some macaques have orally received a total of 5 kg of muscle material over a period of 2 years.

After 5-7 years of incubation time some animals showed clinical symptoms indicative of prion disease, and prion neuropathology and PrPSc deposition were detected in spinal cord and brain of some euthanized animals. PrPSc in immunoblot was weakly detected in some spinal cord materials and various tissues tested positive in RT-QuIC, including lymph node and spleen homogenates. To prove prion infectivity in the macaque tissues, we have intracerebrally inoculated 2 lines of transgenic mice, expressing either elk or human PrP. At least 3 TgElk mice, receiving tissues from 2 different macaques, showed clinical signs of a progressive prion disease and brains were positive in immunoblot and RT-QuIC. Tissues (brain, spinal cord and spleen) from these and pre-clinical mice are currently tested using various read-outs and by second passage in mice. Transgenic mice expressing human PrP were so far negative for clear clinical prion disease (some mice >300 days p.i.). In parallel, the same macaque materials are inoculated into bank voles.

Taken together, there is strong evidence of transmissibility of CWD orally into macaques and from macaque tissues into transgenic mouse models, although with an incomplete attack rate.

The clinical and pathological presentation in macaques was mostly atypical, with a strong emphasis on spinal cord pathology.
Our ongoing studies will show whether the transmission of CWD into macaques and passage in transgenic mice represents a form of non-adaptive prion amplification, and whether macaque-adapted prions have the potential to infect mice expressing human PrP.

The notion that CWD can be transmitted orally into both new-world and old-world non-human primates asks for a careful reevaluation of the zoonotic risk of CWD..

***> The notion that CWD can be transmitted orally into both new-world and old-world non-human primates asks for a careful reevaluation of the zoonotic risk of CWD. <***

Prion Conference 2018

READING OVER THE PRION 2018 ABSTRACT BOOK, LOOKS LIKE THEY FOUND THAT from this study ;

P190 Human prion disease mortality rates by occurrence of chronic wasting disease in freeranging cervids, United States

Abrams JY (1), Maddox RA (1), Schonberger LB (1), Person MK (1), Appleby BS (2), Belay ED (1) (1) Centers for Disease Control and Prevention (CDC), National Center for Emerging and Zoonotic Infectious Diseases, Atlanta, GA, USA (2) Case Western Reserve University, National Prion Disease Pathology Surveillance Center (NPDPSC), Cleveland, OH, USA..

SEEMS THAT THEY FOUND Highly endemic states had a higher rate of prion disease mortality compared to non-CWD
states.

AND ANOTHER STUDY;

P172 Peripheral Neuropathy in Patients with Prion Disease

Wang H(1), Cohen M(1), Appleby BS(1,2) (1) University Hospitals Cleveland Medical Center, Cleveland, Ohio (2) National Prion Disease Pathology Surveillance Center, Cleveland, Ohio..

IN THIS STUDY, THERE WERE autopsy-proven prion cases from the National Prion Disease Pathology Surveillance Center that were diagnosed between September 2016 to March 2017,

AND

included 104 patients. SEEMS THEY FOUND THAT The most common sCJD subtype was MV1-2 (30%), followed by MM1-2 (20%),

AND

THAT The Majority of cases were male (60%), AND half of them had exposure to wild game.

snip…

see more on Prion 2017 Macaque study from Prion 2017 Conference and other updated science on cwd tse prion zoonosis below…terry

Prion 2018 Conference

http://transmissiblespongiformencephalopathy.blogspot.com/2018/05/prion-2018-may-22-25-2018-santiago-de.html

http://prionconference.blogspot.com/2018/

https://prionprp.blogspot.com/2018/12/adrd-summit-rfi-singeltary-comment.html

8. Even though human TSE‐exposure risk through consumption of game from European cervids can be assumed to be minor, if at all existing, no final conclusion can be drawn due to the overall lack of scientific data. In particular the US data do not clearly exclude the possibility of human (sporadic or familial) TSE development due to consumption of venison. The Working Group thus recognizes a potential risk to consumers if a TSE would be present in European cervids. It might be prudent considering appropriate measures to reduce such a risk, e.g. excluding tissues such as CNS and lymphoid tissues from the human food chain, which would greatly reduce any potential risk for consumers. However, it is stressed that currently, no data regarding a risk of TSE infections from cervid products are available.

https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2018.5132

International Conference on Emerging Diseases, Outbreaks & Case Studies & 16th Annual Meeting on Influenza March 28-29, 2018 | Orlando, USA

Qingzhong Kong

Case Western Reserve University School of Medicine, USA

Zoonotic potential of chronic wasting disease prions from cervids

Chronic wasting disease (CWD) is the prion disease in cervids (mule deer, white-tailed deer, American elk, moose, and reindeer). It has become an epidemic in North America, and it has been detected in the Europe (Norway) since 2016. The widespread CWD and popular hunting and consumption of cervid meat and other products raise serious public health concerns, but questions remain on human susceptibility to CWD prions, especially on the potential difference in zoonotic potential among the various CWD prion strains. We have been working to address this critical question for well over a decade. We used CWD samples from various cervid species to inoculate transgenic mice expressing human or elk prion protein (PrP). We found infectious prions in the spleen or brain in a small fraction of CWD-inoculated transgenic mice expressing human PrP, indicating that humans are not completely resistant to CWD prions; this finding has significant ramifications on the public health impact of CWD prions. The influence of cervid PrP polymorphisms, the prion strain dependence of CWD-to-human transmission barrier, and the characterization of experimental human CWD prions will be discussed.

Speaker Biography Qingzhong Kong has completed his PhD from the University of Massachusetts at Amherst and Post-doctoral studies at Yale University. He is currently an Associate Professor of Pathology, Neurology and Regenerative Medicine. He has published over 50 original research papers in reputable journals (including Science Translational Medicine, JCI, PNAS and Cell Reports) and has been serving as an Editorial Board Member on seven scientific journals. He has multiple research interests, including public health risks of animal prions (CWD of cervids and atypical BSE of cattle), animal modeling of human prion diseases, mechanisms of prion replication and pathogenesis, etiology of sporadic Creutzfeldt-Jacob disease (CJD) in humans, normal cellular PrP in the biology and pathology of multiple brain and peripheral diseases, proteins responsible for the α-cleavage of cellular PrP, as well as gene therapy and DNA vaccination.

qxk2@case.edu

https://www.alliedacademies.org/conference-abstracts-files/zoonotic-potential-of-chronic-wasting-disease-prions-from.pdf

https://prionconference.blogspot.com/2018/02/prion-round-table-conference-2018-may.html

http://prionconference.blogspot.com/2018/02/prion-round-table-conference-2018-may.html

http://prionconference.blogspot.com/

SATURDAY, FEBRUARY 23, 2019

Chronic Wasting Disease CWD TSE Prion and THE FEAST 2003 CDC an updated review of the science 2019

https://chronic-wasting-disease.blogspot.com/2019/02/chronic-wasting-disease-cwd-tse-prion.html

TUESDAY, NOVEMBER 04, 2014

Six-year follow-up of a point-source exposure to CWD contaminated venison in an Upstate New York community: risk behaviours and health outcomes 2005–2011

Authors, though, acknowledged the study was limited in geography and sample size and so it couldn't draw a conclusion about the risk to humans. They recommended more study. Dr. Ermias Belay was the report's principal author but he said New York and Oneida County officials are following the proper course by not launching a study. "There's really nothing to monitor presently. No one's sick," Belay said, noting the disease's incubation period in deer and elk is measured in years. "

http://chronic-wasting-disease.blogspot.com/2014/11/six-year-follow-up-of-point-source.html

Transmission Studies

Mule deer transmissions of CWD were by intracerebral inoculation and compared with natural cases {the following was written but with a single line marked through it ''first passage (by this route)}....TSS

resulted in a more rapidly progressive clinical disease with repeated episodes of synocopy ending in coma. One control animal became affected, it is believed through contamination of inoculum (?saline). Further CWD transmissions were carried out by Dick Marsh into ferret, mink and squirrel monkey. Transmission occurred in ALL of these species with the shortest incubation period in the ferret.

snip....

https://web.archive.org/web/20090506002237/http://www..bseinquiry.gov.uk/files/mb/m11b/tab01.pdf

Prion Infectivity in Fat of Deer with Chronic Wasting Disease▿

Brent Race#, Kimberly Meade-White#, Richard Race and Bruce Chesebro* + Author Affiliations

In mice, prion infectivity was recently detected in fat. Since ruminant fat is consumed by humans and fed to animals, we determined infectivity titers in fat from two CWD-infected deer. Deer fat devoid of muscle contained low levels of CWD infectivity and might be a risk factor for prion infection of other species.

http://jvi.asm.org/content/83/18/9608.full

Prions in Skeletal Muscles of Deer with Chronic Wasting Disease

Here bioassays in transgenic mice expressing cervid prion protein revealed the presence of infectious prions in skeletal muscles of CWD-infected deer, demonstrating that humans consuming or handling meat from CWD-infected deer are at risk to prion exposure.

http://science.sciencemag.org/content/311/5764/1117..long

*** now, let’s see what the authors said about this casual link, personal communications years ago, and then the latest on the zoonotic potential from CWD to humans from the TOKYO PRION 2016 CONFERENCE.

see where it is stated NO STRONG evidence. so, does this mean there IS casual evidence ???? “Our conclusion stating that we found no strong evidence of CWD transmission to humans”

From: TSS

Subject: CWD aka MAD DEER/ELK TO HUMANS ???

Date: September 30, 2002 at 7:06 am PST

From: "Belay, Ermias"

To: Cc: "Race, Richard (NIH)" ; ; "Belay, Ermias"

Sent: Monday, September 30, 2002 9:22 AM

Subject: RE: TO CDC AND NIH - PUB MED- 3 MORE DEATHS - CWD - YOUNG HUNTERS

Dear Sir/Madam,

In the Archives of Neurology you quoted (the abstract of which was attached to your email), we did not say CWD in humans will present like variant CJD.. That assumption would be wrong. I encourage you to read the whole article and call me if you have questions or need more clarification (phone: 404-639-3091). Also, we do not claim that "no-one has ever been infected with prion disease from eating venison." Our conclusion stating that we found no strong evidence of CWD transmission to humans in the article you quoted or in any other forum is limited to the patients we investigated.

Ermias Belay, M.D. Centers for Disease Control and Prevention

-----Original Message-----

From: Sent: Sunday, September 29, 2002 10:15 AM

To: rr26k@nih.gov; rrace@niaid.nih.gov; ebb8@CDC.GOV

Subject: TO CDC AND NIH - PUB MED- 3 MORE DEATHS - CWD - YOUNG HUNTERS

Sunday, November 10, 2002 6:26 PM .......snip........end..............TSS

Thursday, April 03, 2008

A prion disease of cervids: Chronic wasting disease 2008 1: Vet Res. 2008 Apr 3;39(4):41 A prion disease of cervids: Chronic wasting disease Sigurdson CJ.

snip...

*** twenty-seven CJD patients who regularly consumed venison were reported to the Surveillance Center***,

snip... full text ;

http://chronic-wasting-disease.blogspot.com/2008/04/prion-disease-of-cervids-chronic.html

*** I urge everyone to watch this video closely...terry

*** you can see video here and interview with Jeff's Mom, and scientist telling you to test everything and potential risk factors for humans ***

https://histodb11.usz.ch/Images/videos/video-004/video-004.html

*** 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.

http://cdmrp.army.mil/prevfunded/nprp/NPRP_Summit_Final_Report.pdf

> However, to date, no CWD infections have been reported in people.

sporadic, spontaneous CJD, 85%+ of all human TSE, just not just happen. never in scientific literature has this been proven.

if one looks up the word sporadic or spontaneous at pubmed, you will get a laundry list of disease that are classified in such a way;

sporadic = 54,983 hits https://www.ncbi.nlm.nih.gov/pubmed/?term=sporadic

spontaneous = 325,650 hits https://www.ncbi.nlm.nih.gov/pubmed/?term=spontaneous

key word here is 'reported'. science has shown that CWD in humans will look like sporadic CJD. SO, how can one assume that CWD has not already transmitted to humans? they can't, and it's as simple as that. from all recorded science to date, CWD has already transmitted to humans, and it's being misdiagnosed as sporadic CJD. ...terry

*** LOOKING FOR CWD IN HUMANS AS nvCJD or as an ATYPICAL CJD, LOOKING IN ALL THE WRONG PLACES $$$ ***

http://www.tandfonline.com/doi/full/10.4161/pri.28124?src=recsys

http://www.tandfonline.com/doi/pdf/10.4161/pri.28124?needAccess=true

https://wwwnc.cdc.gov/eid/article/20/1/13-0858_article

CWD TSE PRION AND ZOONOTIC, ZOONOSIS, POTENTIAL

Subject: Re: DEER SPONGIFORM ENCEPHALOPATHY SURVEY & HOUND STUDY

Date: Fri, 18 Oct 2002 23:12:22 +0100

From: Steve Dealler

Reply-To: Bovine Spongiform Encephalopathy Organization: Netscape Online member

To: BSE-L@ References: <3daf5023 .4080804="" wt.net="">

Dear Terry,

An excellent piece of review as this literature is desparately difficult to get back from Government sites.

What happened with the deer was that an association between deer meat eating and sporadic CJD was found in about 1993. The evidence was not great but did not disappear after several years of asking CJD cases what they had eaten. I think that the work into deer disease largely stopped because it was not helpful to the UK industry...and no specific cases were reported. Well, if you dont look adequately like they are in USA currenly then you wont find any!

Steve Dealler ===============

https://caninespongiformencephalopathy.blogspot.com/2010/03/canine-spongiform-encephalopathy-aka.html

Stephen Dealler is a consultant medical microbiologist deal@airtime.co.uk

BSE Inquiry Steve Dealler

Management In Confidence

BSE: Private Submission of Bovine Brain Dealler

snip...see full text;

MONDAY, FEBRUARY 25, 2019

***> MAD DOGS AND ENGLISHMEN BSE, SCRAPIE, CWD, CJD, TSE PRION A REVIEW 2019

https://bseinquiry.blogspot.com/2019/02/mad-dogs-and-englishmen-bse-scrapie-cwd.html

THURSDAY, DECEMBER 17, 2020

Exposure Risk of Chronic Wasting Disease in Humans

https://chronic-wasting-disease.blogspot.com/2020/12/exposure-risk-of-chronic-wasting.html

*** IF CWD is not a risk factor for humans, then I guess the FDA et al recalled all this CWD tainted elk tenderloin (2009 Exotic Meats USA of San Antonio, TX) for the welfare and safety of the dead elk. ...tss

Exotic Meats USA Announces Urgent Statewide Recall of Elk Tenderloin Because It May Contain Meat Derived From An Elk Confirmed To Have Chronic Wasting Disease

Contact: Exotic Meats USA 1-800-680-4375

FOR IMMEDIATE RELEASE -- February 9, 2009 -- Exotic Meats USA of San Antonio, TX is initiating a voluntary recall of Elk Tenderloin because it may contain meat derived from an elk confirmed to have Chronic Wasting Disease (CWD). The meat with production dates of December 29, 30 and 31, 2008 was purchased from Sierra Meat Company in Reno, NV. The infected elk came from Elk Farm LLC in Pine Island, MN and was among animals slaughtered and processed at USDA facility Noah’s Ark Processors LLC.

Chronic Wasting Disease (CWD) is a fatal brain and nervous system disease found in elk and deer. The disease is caused by an abnormally shaped protein called a prion, which can damage the brain and nerves of animals in the deer family. Currently, it is believed that the prion responsible for causing CWD in deer and elk is not capable of infecting humans who eat deer or elk contaminated with the prion, but the observation of animal-to-human transmission of other prion-mediated diseases, such as bovine spongiform encephalopathy (BSE), has raised a theoretical concern regarding the transmission of CWD from deer or elk to humans. At the present time, FDA believes the risk of becoming ill from eating CWD-positive elk or deer meat is remote. However, FDA strongly advises consumers to return the product to the place of purchase, rather than disposing of it themselves, due to environmental concerns.

Exotic Meats USA purchased 1 case of Elk Tenderloins weighing 16.9 lbs. The Elk Tenderloin was sold from January 16 – 27, 2009. The Elk Tenderloins was packaged in individual vacuum packs weighing approximately 3 pounds each. A total of six packs of the Elk Tenderloins were sold to the public at the Exotic Meats USA retail store. Consumers who still have the Elk Tenderloins should return the product to Exotic Meats USA at 1003 NE Loop 410, San Antonio, TX 78209. Customers with concerns or questions about the Voluntary Elk Recall can call 1-800-680-4375. The safety of our customer has always been and always will be our number one priority.

Exotic Meats USA requests that for those customers who have products with the production dates in question, do not consume or sell them and return them to the point of purchase. Customers should return the product to the vendor. The vendor should return it to the distributor and the distributor should work with the state to decide upon how best to dispose. If the consumer is disposing of the product he/she should consult with the local state EPA office.

RSS Feed for FDA Recalls Information11 [what's this?12]

http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2009/ucm128543.htm

Scientific Advisors and Consultants Staff 2001 Advisory Committee TSE PRION Singeltary Submission Freas Monday, January 08,2001 3:03 PM FDA Singeltary submission 2001

Greetings again Dr. Freas and Committee Members,

I wish to submit the following information to the Scientific Advisors and Consultants Staff 2001 Advisory Committee (short version). I understand the reason of having to shorten my submission, but only hope that you add it to a copy of the long version, for members to take and read at their pleasure, (if cost is problem, bill me, address below). So when they realize some time in the near future of the 'real' risks i speak of from human/animal TSEs and blood/surgical products. I cannot explain the 'real' risk of this in 5 or 10 minutes at some meeting, or on 2 or 3 pages, but will attempt here:

fda link is dead in the water;

http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf

snip...see full text

https://bseusa.blogspot.com/2019/03/scientific-advisors-and-consultants.html

the British disease...NOT, the UKBSEnvCJD only theory was/is bogus $$$

https://histodb11.usz.ch/Images/videos/video-009/video-009.html

*** USA sporadic CJD MAD COW DISEASE HAS HUGE PROBLEM Video

*** sporadic CJD linked to mad cow disease

*** you can see video here and interview with Jeff's Mom, and scientist telling you to test everything and potential risk factors for humans ***

https://histodb11.usz.ch/Images/videos/video-004/video-004.html

MAD DOGS AND ENGLISHMEN BSE, SCRAPIE, CWD, CJD, TSE PRION A REVIEW 2019

BSE INQUIRY EVIDENCE

Why did the appearance of new TSEs in animals matter so much? It has always been known that TSEs will transfer across species boundaries. The reason for this was never known until the genetic nature of the prion gene was fully investigated and found to be involved. The gene is found to have well preserved sites and as such there is a similar gene throughout the animal kingdom...and indeed a similar gene is found in insects! It is NOT clear that the precise close nature of the PrP gene structure is essention for low species barriers. Indeed it is probably easier to infect cats with BSE than it is to infect sheep. As such it is not clear that simply because it is possible to infect BSE from cattle into certain monkeys then other apes will necessarily be infectable with the disease. One factor has stood out, however, and that is that BSE, when inoculated into mice would retain its apparent nature of disease strain, and hence when it was inoculated back into cattle, then the same disease was produced. Similarly if the TSE from kudu was inoculated into mice then a similar distribution of disease in the brain of the mouse is seen as if BSE had been inoculated into the mouse. This phenomenon was not true with scrapie, in which the transmission across a species barrier was known to lose many of the scrapie strain phenomena in terms of incubation period or disease histopathology. This also suggested that BSE was not derived from scrapie originally but we probably will never know.

------------------------------------------------------------------------

TSE in wild UK deer? The first case of BSE (as we now realise) was in a nyala in London zoo and the further zoo cases in ungulates were simply thought of as being interesting transmissions of scrapie initially. The big problem started to appear with animals in 1993-5 when it became clear that there was an increase in the CJD cases in people that had eaten deer although the statistics involved must have been questionable. The reason for this was that the CJD Surveillance was well funded to look into the diet of people dying of CJD. This effect is not clear with vCJD...if only because the numbers involved are much smaller and hence it is difficult to gain enough statistics. They found that many other foods did not appear to have much association at all but that deer certainly did and as years went by the association actually became clearer. The appearance of vCJD in 1996 made all this much more difficult in that it was suddenly clearer that the cases of sporadic CJD that they had been checking up until then probably had nothing to do with beef...and the study decreased. During the period there was an increasing worry that deer were involved with CJD..

see references:

DEER BRAIN SURVEY

https://web.archive.org/web/20090506025229/http://www.bseinquiry.gov.uk/files/yb/1991/11/20004001.pdf

https://www.facebook.com/groups/1557515941145821/permalink/2299600233604051/?hc_location=ufi

i have not updated my blogspot url with all this data archived, but i will work on it...but until then, i have updated this on the above links with live urls to the actual BSE Inquiry documents...

Subject: Re: DEER SPONGIFORM ENCEPHALOPATHY SURVEY & HOUND STUDY

Date: Fri, 18 Oct 2002 23:12:22 +0100

From: Steve Dealler

Reply-To: Bovine Spongiform Encephalopathy Organization: Netscape Online member

To: BSE-L@ References: <3daf5023 .4080804="" wt.net="">

Dear Terry,

An excellent piece of review as this literature is desparately difficult to get back from Government sites.

Steve Dealler ===============

https://caninespongiformencephalopathy.blogspot.com/2010/03/canine-spongiform-encephalopathy-aka.html

Stephen Dealler is a consultant medical microbiologist deal@airtime.co.uk

BSE Inquiry Steve Dealler

Management In Confidence

BSE: Private Submission of Bovine Brain Dealler

https://web.archive.org/web/20090506043910/http://www.bseinquiry.gov.uk/files/yb/1993/12/08003001.pdf

reports of sheep and calf carcasses dumped...

https://web.archive.org/web/20090505232801/http://www.bseinquiry.gov.uk/files/yb/1993/12/07002001.pdf

re-scrapie to cattle GAH Wells BSE Inquiry

https://web.archive.org/web/20090506043931/http://www.bseinquiry.gov.uk/files/yb/1993/12/09001001.pdf

Dr. Dealler goes rogue to confirm BSE

https://web.archive.org/web/20090506043930/http://www.bseinquiry.gov.uk/files/yb/1993/12/14003001.pdf

https://web.archive.org/web/20090505231533/http://www.bseinquiry.gov.uk/files/yb/1993/12/17003001.pdf

Confirmation BSE Dealler's mad cow

https://web.archive.org/web/20090505231342/http://www.bseinquiry.gov.uk/files/yb/1993/12/16006001.pdf

BSE vertical transmission

https://web.archive.org/web/20090506043834/http://www.bseinquiry.gov.uk/files/yb/1993/12/13003001.pdf

1993 cjd report finds relationship with eat venison and cjd increases 9 fold, let the cover up begin...tss

https://web.archive.org/web/20090506050244/http://www.bseinquiry.gov.uk/files/yb/1994/07/00001001.pdf

FINDINGS

*** 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 ;

https://web.archive.org/web/2 0170126073306/http://collections..europarchive..org/tna/20090505194948/http://bseinquiry.gov.uk/files/yb/1994/08/00004001.pdf

GAME FARM INDUSTRY WANTS TO COVER UP FINDINGS OF INCREASE RISK TO CJD FROM CERVID

BSE INQUIRY

CJD9/10022

October 1994

Mr R.N. Elmhirst Chairman British Deer Farmers Association Holly Lodge Spencers Lane

BerksWell Coventry CV7 7BZ

Dear Mr Elmhirst,

CREUTZFELDT-JAKOB DISEASE (CJD) SURVEILLANCE UNIT REPORT

Thank you for your recent letter concerning the publication of the third annual report from the CJD Surveillance Unit. I am sorry that you are dissatisfied with the way in which this report was published.

The Surveillance Unit is a completely independant outside body and the Department of Health is committed to publishing their reports as soon as they become available. In the circumstances it is not the practice to circulate the report for comment since the findings of the report would not be amended.. In future we can ensure that the British Deer Farmers Association receives a copy of the report in advance of publication.

The Chief Medical Officer has undertaken to keep the public fully informed of the results of any research in respect of CJD. This report was entirely the work of the unit and was produced completely independantly of the the Department.

The statistical results reqarding the consumption of venison was put into perspective in the body of the report and was not mentioned at all in the press release. Media attention regarding this report was low key but gave a realistic presentation of the statistical findings of the Unit. This approach to publication was successful in that consumption of venison was highlighted only once by the media ie. in the News at one television proqramme.

I believe that a further statement about the report, or indeed statistical links between CJD and consumption of venison, would increase, and quite possibly give damaging credence, to the whole issue. From the low key media reports of which I am aware it seems unlikely that venison consumption will suffer adversely, if at all.

http://web.archive.org/web/20030511010117/http://www.bseinquiry.gov.uk/files/yb/1994/10/00003001.pdf

The BSE Inquiry / Statement No 324

Dr James Kirkwood (not scheduled to give oral evidence)

Statement to the BSE Inquiry

James K Kirkwood BVSc PhD FIBiol MRCVS

[This witness has not been asked to give oral evidence in Phase 1 of the Inquiry]

1. I became involved in the field of TSEs through my work as Head of the Veterinary Science Group at the Zoological Society of London’s Institute of Zoology. I held this post from November 1984 until June 1996, when I took up my present post at UFAW. During this time, concurrent with the BSE epidemic, cases of scrapie-like spongiform encephalopathies occurred in animals at the Zoological Society of London’s collections at Regent’s Park and Whipsnade and in other zoos. It was appropriate to investigate the epidemiology of these cases in order to try to determine the possible impact on zoo animals and breeding programmes, and to consider how the disease in zoo animals might be controlled.

2. Throughout the period from 1985 to March 1996, I worked at the Institute of Zoology (IoZ). I was Head of the Veterinary Science Group of the IoZ and Senior Veterinary Officer of the Zoological Society of London (ZSL). I was responsible for the provision of the veterinary service for the ZSL collections.

3. During the period from 1985 to March 1996, scrapie-like spongiform encephalopathies were diagnosed in the following animals which died, or were euthanased, at London Zoo and Whipsnade:

Animal Sex Date of Death Age (mos)

Arabian Oryx Oryx leucoryx F 24.3.89 38

Greater kudu Tragelaphus strepsiceros (Linda) F 18.8.89 30

Greater kudu (Karla) F 13.11.90 19 Greater kudu (Kaz) M 6.6.91 37

Greater kudu (Bambi) M 24.10.91 36

Greater kudu (346/90) M 26.2.92 18

Greater kudu (324/90) F 22.11.92 38

Cheetah Acinonyx jubatus (Michelle) F 22.12.93 91

All these cases were described in papers published in the scientific literature (as cited below).

https://web.archive.org/web/20090506004016/http://www.bseinquiry.gov.uk/files/ws/s324.pdf

MONDAY, JANUARY 04, 2021

NC1209: North American interdisciplinary chronic wasting disease research consortium Singeltary Submission January 2021

https://chronic-wasting-disease.blogspot.com/2021/01/nc1209-north-american-interdisciplinary.html

Friday, December 14, 2012

DEFRA U.K. What is the risk of Chronic Wasting Disease CWD being introduced into Great Britain? A Qualitative Risk Assessment October 2012

snip.....

In the USA, under the Food and Drug Administration's BSE Feed Regulation (21 CFR 589.2000) most material (exceptions include milk, tallow, and gelatin) from deer and elk is prohibited for use in feed for ruminant animals. With regards to feed for non-ruminant animals, under FDA law, CWD positive deer may not be used for any animal feed or feed ingredients. For elk and deer considered at high risk for CWD, the FDA recommends that these animals do not enter the animal feed system. However, this recommendation is guidance and not a requirement by law. Animals considered at high risk for CWD include:

1) animals from areas declared to be endemic for CWD and/or to be CWD eradication zones and

2) deer and elk that at some time during the 60-month period prior to slaughter were in a captive herd that contained a CWD-positive animal.

Therefore, in the USA, materials from cervids other than CWD positive animals may be used in animal feed and feed ingredients for non-ruminants.

The amount of animal PAP that is of deer and/or elk origin imported from the USA to GB can not be determined, however, as it is not specified in TRACES.

It may constitute a small percentage of the 8412 kilos of non-fish origin processed animal proteins that were imported from US into GB in 2011.

Overall, therefore, it is considered there is a __greater than negligible risk___ that (nonruminant) animal feed and pet food containing deer and/or elk protein is imported into GB.

There is uncertainty associated with this estimate given the lack of data on the amount of deer and/or elk protein possibly being imported in these products.

snip.....

36% in 2007 (Almberg et al., 2011). In such areas, population declines of deer of up to 30 to 50% have been observed (Almberg et al., 2011). In areas of Colorado, the prevalence can be as high as 30% (EFSA, 2011). The clinical signs of CWD in affected adults are weight loss and behavioural changes that can span weeks or months (Williams, 2005). In addition, signs might include excessive salivation, behavioural alterations including a fixed stare and changes in interaction with other animals in the herd, and an altered stance (Williams, 2005). These signs are indistinguishable from cervids experimentally infected with bovine spongiform encephalopathy (BSE). Given this, if CWD was to be introduced into countries with BSE such as GB, for example, infected deer populations would need to be tested to differentiate if they were infected with CWD or BSE to minimise the risk of BSE entering the human food-chain via affected venison. snip..... The rate of transmission of CWD has been reported to be as high as 30% and can approach 100% among captive animals in endemic areas (Safar et al., 2008).

snip.....

In summary, in endemic areas, there is a medium probability that the soil and surrounding environment is contaminated with CWD prions and in a bioavailable form. In rural areas where CWD has not been reported and deer are present, there is a greater than negligible risk the soil is contaminated with CWD prion. snip..... In summary, given the volume of tourists, hunters and servicemen moving between GB and North America, the probability of at least one person travelling to/from a CWD affected area and, in doing so, contaminating their clothing, footwear and/or equipment prior to arriving in GB is greater than negligible... For deer hunters, specifically, the risk is likely to be greater given the increased contact with deer and their environment. However, there is significant uncertainty associated with these estimates.

snip.....

Therefore, it is considered that farmed and park deer may have a higher probability of exposure to CWD transferred to the environment than wild deer given the restricted habitat range and higher frequency of contact with tourists and returning GB residents.

snip.....

https://web.archive.org/web/20170404125557/http://webarchive.nationalarchives.gov.uk/20130822084033/http://www.defra.gov.uk/animal-diseases/files/qra_chronic-wasting-disease-121029.pdf

***> READ THIS VERY, VERY, CAREFULLY, AUGUST 1997 MAD COW FEED BAN WAS A SHAM, AS I HAVE STATED SINCE 1997! 3 FAILSAFES THE FDA ET AL PREACHED AS IF IT WERE THE GOSPEL, IN TERMS OF MAD COW BSE DISEASE IN USA, AND WHY IT IS/WAS/NOT A PROBLEM FOR THE USA, and those are;

BSE TESTING (failed terribly and proven to be a sham)

BSE SURVEILLANCE (failed terribly and proven to be a sham)

BSE 589.2001 FEED REGULATIONS (another colossal failure, and proven to be a sham)

these are facts folks. trump et al just admitted it with the feed ban.

see;

FDA Reports on VFD Compliance

John Maday

August 30, 2019 09:46 AM VFD-Form 007 (640x427)

Before and after the current Veterinary Feed Directive rules took full effect in January, 2017, the FDA focused primarily on education and outreach. ( John Maday ) Before and after the current Veterinary Feed Directive (VFD) rules took full effect in January, 2017, the FDA focused primarily on education and outreach to help feed mills, veterinarians and producers understand and comply with the requirements. Since then, FDA has gradually increased the number of VFD inspections and initiated enforcement actions when necessary. On August 29, FDA released its first report on inspection and compliance activities. The report, titled “Summary Assessment of Veterinary Feed Directive Compliance Activities Conducted in Fiscal Years 2016 – 2018,” is available online.

https://www.fda.gov/media/130382/download

SUNDAY, SEPTEMBER 1, 2019

***> FDA Reports on VFD Compliance

https://bovineprp.blogspot.com/2019/09/fda-reports-on-vfd-compliance.html

TUESDAY, APRIL 18, 2017

*** EXTREME USA FDA PART 589 TSE PRION FEED LOOP HOLE STILL EXIST, AND PRICE OF POKER GOES UP ***

http://usdameatexport.blogspot.com/2017/04/extreme-usa-fda-part-589-tse-prion-feed.html

MONDAY, MAY 20, 2019

Tracking and clarifying differential traits of classical- and atypical L-type bovine spongiform encephalopathy prions after transmission from cattle to cynomolgus monkeys

https://bse-atypical.blogspot.com/2019/05/tracking-and-clarifying-differential.html

SUNDAY, APRIL 14, 2019

Estimation of prion infectivity in tissues of cattle infected with atypical BSE by real time-quaking induced conversion assay

https://bse-atypical.blogspot.com/2019/04/estimation-of-prion-infectivity-in.html

WEDNESDAY, APRIL 24, 2019

USDA Announces Atypical Bovine Spongiform Encephalopathy Detection Aug 29, 2018 A Review of Science 2019

https://bse-atypical.blogspot.com/2019/04/usda-announces-atypical-bovine.html

THURSDAY, JANUARY 7, 2021

Atypical Nor-98 Scrapie TSE Prion USA State by State Update January 2021

https://nor-98.blogspot.com/2021/01/atypical-nor-98-scrapie-tse-prion-usa.html

TUESDAY, SEPTEMBER 22, 2020

APHIS USDA MORE SCRAPIE ATYPICAL Nor-98 Confirmed USA September 15 2020

https://scrapie-usa.blogspot.com/2020/09/aphis-usda-more-scrapie-atypical-nor-98.html

THURSDAY, DECEMBER 31, 2020

Autoclave treatment of the classical scrapie agent US No. 13-7 and experimental inoculation to susceptible VRQ/ARQ sheep via the oral route results in decreased transmission efficiency

https://scrapie-usa.blogspot.com/2020/12/autoclave-treatment-of-classical.html

WEDNESDAY, MAY 29, 2019

***> Incomplete inactivation of atypical scrapie following recommended autoclave decontamination procedures

https://nor-98.blogspot.com/2019/05/incomplete-inactivation-of-atypical.html

TUESDAY, DECEMBER 01, 2020

Sporadic Creutzfeldt Jakob Disease sCJD and Human TSE Prion Annual Report December 14, 2020

https://creutzfeldt-jakob-disease.blogspot.com/2020/12/sporadic-creutzfeldt-jakob-disease-scjd.html

https://www.google.com/search?safe=active&biw=1067&bih=505&ei=M1QLYJrvI5XNtQanl7aoDg&q=fda+warning+letter+nutritional+supplements+CJD+terry+singeltary&oq=fda+warning+letter+nutritional+supplements+CJD+terry+singeltary&gs_lcp=CgZwc3ktYWIQAzoECCEQClCiTFjIT2DYUWgAcAB4AIABWogBnAOSAQE1mAEAoAEBqgEHZ3dzLXdpesABAQ&sclient=psy-ab&ved=0ahUKEwja1MDszbDuAhWVZs0KHaeLDeU4HhDh1QMIDQ&uact=5

Terry S. Singeltary Sr.

CREUTZFELDT JAKOB DISEASE

Pages

Friday, January 22, 2021

Creutzfeldt Jakob Disease TSE Prion and Nutritional Supplements, Porcine Products, what you need to know

highly refined products hrp

European Union (EU) - Export requirements for highly refined products

Eligible/ineligible product

Eligible

Ineligible

Pre-export approvals by competent authority of importing country

Establishments

Production controls and inspection requirements

Imported ingredients of animal origin

Labelling, packaging and marking requirements

Export documents available upon request

Certificate

Information required to complete EU health certificate

Additional information