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From: TSS ()
Subject: EXPORTATION AND IMPORTATION OF ANIMALS AND ANIMAL PRODUCTS: BSE; MRR AND IMPORTATION OF COMMODITIES, 65758-65759 [E6-19042]
Date: November 9, 2006 at 1:38 pm PST

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection

Service

9 CFR Parts 93, 94, and 95

[Docket No. APHIS–2006–0026]

Bovine Spongiform Encephalopathy;

Minimal-Risk Regions, Identification of

Ruminants and Processing and

Importation of Commodities

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Proposed rule; reopening of

comment period.

SUMMARY: We are reopening the

comment period for our proposed rule

that would remove several restrictions

regarding the identification of animals

and the processing of ruminant

materials from BSE minimal-risk

regions, as well as BSE-based

restrictions on gelatin derived from

bovine hides. This action will allow

interested persons additional time to

prepare and submit comments.

DATES: We will consider all comments

that we receive on or before November

24, 2006.

ADDRESSES: You may submit comments

by either of the following methods:

• Federal eRulemaking Portal: Go to

http://www.regulations.gov, select

‘‘Animal and Plant Health Inspection

Service’’ from the agency drop-down

menu, then click ‘‘Submit.’’ In the

Docket ID column, select APHIS–2006–

0026 to submit or view public

VerDate Aug<31>2005 14:28 Nov 08, 2006 Jkt 211001 PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 E:\FR\FM\09NOP1.SGM 09NOP1 rmajette on PROD1PC67 with PROPOSALS1

65759 Federal Register / Vol. 71, No. 217 / Thursday, November 9, 2006 / Proposed Rules

comments and to view supporting and

related materials available

electronically. Information on using

Regulations.gov, including instructions

for accessing documents, submitting

comments, and viewing the docket after

the close of the comment period, is

available through the site’s ‘‘User Tips’’

link.

• Postal Mail/Commercial Delivery:

Please send four copies of your

comment (an original and three copies)

to Docket No. APHIS–2006–0026,

Regulatory Analysis and Development,

PPD, APHIS, Station 3A–03.8, 4700

River Road Unit 118, Riverdale, MD

20737–1238. Please state that your

comment refers to Docket No. APHIS–

2006–0026.

Reading Room: You may read any

comments that we receive on Docket

No. APHIS–2006–0026 in our reading

room. The reading room is located in

room 1141 of the USDA South Building,

14th Street and Independence Avenue,

SW., Washington, DC. Normal reading

room hours are 8 a.m. to 4:30 p.m.,

Monday through Friday, except

holidays. To be sure someone is there to

help you, please call (202) 690–2817

before coming.

Other Information: Additional

information about APHIS and its

programs is available on the Internet at

http://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT: For

information regarding ruminant

products, contact Dr. Karen James-

Preston, Director, Technical Trade

Services, Animal Products, National

Center for Import and Export, VS,

APHIS, 4700 River Road, Unit 38,

Riverdale, MD 20737–1231; (301) 734–

4356.

For information concerning live

ruminants, contact Dr. Lee Ann Thomas,

Director, Technical Trade Services,

Animals, Organisms and Vectors, and

Select Agents, National Center for

Import and Export, VS, APHIS, 4700

River Road, Unit 38, Riverdale, MD

20737–1231; (301) 734–4356.

SUPPLEMENTARY INFORMATION: On August

9, 2006, we published in the Federal

Register (71 FR 45439–45444, Docket

No. APHIS–2006–0026) a proposal to

remove several restrictions regarding the

identification of animals and the

processing of ruminant materials from

BSE minimal-risk regions, as well as

BSE-based restrictions on gelatin

derived from bovine hides.

Comments on the proposed rule were

required to be received on or before

October 10, 2006. We are reopening the

comment period on Docket No. APHIS–

2006–0026 for an additional 14 days.

This action will allow interested

persons additional time to prepare and

submit comments. We will also consider

all comments received between October

11, 2006, and the date of this notice.

Authority: 7 U.S.C. 450, 1622, 7701–7772,

7781–7786, and 8301–8317; 21 U.S.C. 136

and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80,

and 371.4.

Done in Washington, DC, this 3rd of

November 2006.

Kevin Shea,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. E6–19042 Filed 11–8–06; 8:45 am]

BILLING CODE 3410–34–P

http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/E6-19042.pdf

Exportation and importation of animals and animal products:

Bovine spongiform encephalopathy; minimal-risk regions and importation of commodities,
65758–65759 [E6–19042]

IN REALITY, WHAT THIS MEANS IS IN ADDITION TO IMPORTATION OF COMMODITIES, YOU WILL BE IMPORTING FROM A COUNTRY THAT HAS THE MOST DOCUMENTED TSE THAN ANY OTHER NATION IN THE WORLD DUE TO NON-COMPLIANCE OF RUMINANT FEED BAN FOR ONE THING, AND OUTRIGHT DECEIT AND CORRUPTION FOR ANOTHER. DO YOU WANT TO EXPOSE YOUR PEOPLE TO THIS ALL FOR A BUCK $$$ THE USDA DOES. ...TSS

IN a time when FSIS/APHIS/USDA/FDA et al should be strengthening the TSE regulations, it seems corporate interest has won out again over sound science and consumer protection from an agent that is 100% fatal for the ones that go clinical. With the many different atypical TSEs showing up in different parts of the world, and with GWs BSE MRR policy (the legal policy of trading all strains of TSEs), the battle that has waged for the last 25 years to eradicate this agent from this planet will be set back decades, if not lost for good. ...

http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf

TO REDUCE TESTING OF BSE IN THE USA TO ONLY 40,000 A YEAR, is simply not scientific regardless of

what the OIE BSE testing protocol calls for. ALL one has

to do is look at the countries above that all went down with BSE, that all went by the infamous OIE BSE testing

protocols. THEN and only then, after the USA finally fumbled the 'BSE FREE' golden egg and accidently had to

document a case or two of mad cow, low and behold, what next? yep, you guessed it, time to move the goal post in the

middle of the football game, GWs and his sleeping partners at the OIE, gave birth to the BSE MRR policy, the legal

trading of all strains of TSE globally was born. ...

BILLING CODE: 3410-34-P

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 93, 94, 95, and 96

[Docket No. 03-080-3]

RIN 0579-AB73

Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

Page 82 of 98

8/3/2006

SUMMARY: We are amending the regulations regarding the importation of animals and animal

products to establish a category of regions that present a minimal risk of introducing bovine

spongiform encephalopathy (BSE) into the United States via live ruminants and ruminant

products and byproducts, and we are adding Canada to this category. We are also establishing

conditions for the importation of certain live ruminants and ruminant products and byproducts

from such regions. These actions will continue to protect against the introduction of BSE into

the United States while removing unnecessary prohibitions on the importation of certain

commodities from minimal-risk regions for BSE, currently only Canada.

EFFECTIVE DATE: [Insert date 60 days after date of publication in the Federal Register].

FOR FURTHER INFORMATION CONTACT: For information concerning ruminant products,

contact Dr. Karen James-Preston, Director, Technical Trade Services, National Center for Import

and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-4356.

For information concerning live ruminants, contact Lee Ann Thomas, Director, Technical

Trade Services, Animals, Organisms and Vectors, and Select Agents, National Center for Import

and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-4356.

http://www.aphis.usda.gov/lpa/issues/bse/03-080-3_final_rule.pdf

[Federal Register: November 4, 2003 (Volume 68, Number 213)]

[Proposed Rules]

[Page 62386-62405]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr04no03-5]

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

Proposed Rules

Federal Register

________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of

the proposed issuance of rules and regulations. The purpose of these

notices is to give interested persons an opportunity to participate in

the rule making prior to the adoption of the final rules.

Page 83 of 98

8/3/2006

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

[[Page 62386]]

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 93, 94, and 95

[Docket No. 03-080-1]

RIN 0579-AB73

Bovine Spongiform Encephalopathy; Minimal Risk Regions and

Importation of Commodities

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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

SUMMARY: We are proposing to amend the regulations regarding the

importation of animals and animal products to recognize a category of

regions that present a minimal risk of introducing bovine spongiform

encephalopathy (BSE) into the United States via live ruminants and

ruminant products, and are proposing to add Canada to this category. We

are also proposing to allow the importation of certain live ruminants

and ruminant products and byproducts from such regions under certain

conditions. We believe this action is warranted because it would

continue to protect against the introduction of BSE into the United

States while removing unnecessary prohibitions on certain commodities

from Canada and other regions that qualify as BSE minimal-risk regions.

DATES: We will consider all comments that we receive on or before

January 5, 2004.

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2003_register&docid=fr04no03-5

[Federal Register: April 8, 2005 (Volume 70, Number 67)]

[Rules and Regulations]

[Page 18251-18262]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr08ap05-11]

Page 84 of 98

8/3/2006

[[Page 18251]]

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

Part VII

Department of Agriculture

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

Animal and Plant Health Inspection Service

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

9 CFR Part 93, et al.

Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation

of Commodities; Finding of No Significant Impact and Affirmation of

Final Rule; Final Rule

[[Page 18252]]

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

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 93, 94, 95, and 98

[Docket No. 03-080-7]

RIN 0579-AB73

Bovine Spongiform Encephalopathy; Minimal-Risk Regions and

Importation of Commodities; Finding of No Significant Impact and

Affirmation of Final Rule

AGENCY: Animal and Plant Health Inspection Service, USDA.

Page 85 of 98

8/3/2006

ACTION: Affirmation of final rule.

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

SUMMARY: We are publishing a finding of no significant impact for a

final rule concerning bovine spongiform encephalopathy minimal risk

regions published January 4, 2005, and, based on that finding, we are

affirming the provisions of the final rule. The finding of no

significant impact is based on an environmental assessment that

documented our review and analysis of potential environmental impacts

associated with the final rule and our review of issues raised by the

public regarding the environmental assessment. Together, the

environmental assessment and our review of the issues raised provide a

basis for our conclusion that the provisions of the final rule will not

have a significant impact on the quality of the human environment and

support our affirmation of the final rule.

DATES: The final rule published January 4, 2005 (70 FR 460), with a

partial delay of applicability published March 11, 2005 (70 FR 12112),

was effective March 7, 2005. This affirmation of the final rule is

effective April 8, 2005.

http://a257.g.akamaitech.net/7/257/2422/01jan20051800/edocket.access.gpo.gov/2005/05-7141.htm

World Animal Health Body Changes Mad Cow Risk Definitions

WASHINGTON, DC, May 31, 2006 (ENS) - Member countries of the World Organization for Animal Health (OIE)

last week voted unanimously to revise the three definitions of risk categories for countries affected by mad cow

disease, formally known as bovine spongiform encephalopathy (BSE).

The three definitions are - negligible risk, controlled risk, and undetermined risk of cattle being infected with the fatal

brain-wasting disease.

Previously, a country that discovered a case of BSE had to wait seven years from the date of its latest discovery before

being eligible to be classified as a “negligible risk” country, the category for countries with the least amount of risk

from the disease.

Under these guidelines, the United States would have had to wait until the year 2013 to be classified as a negligible risk

country after a veterinarian discovered a cow infected with the disease in Alabama in March, the third infected U.S.

cow to be found.

Now, as a result of OIE’s decision, countries work from the date of birth of the animal discovered to be infected with

the BSE agent – misfolded proteins called prions.

The decision was made at the OIE's Annual General Session held in Paris from May 21 to 26.

Page 86 of 98

8/3/2006

The General Session notably brings together representatives appointed by the governments of the 167 OIE member

countries. Some 600 participants representing member countries and intergovernmental organizations such as the UN

Food and Agriculture Organization, the World Health Organization, the World Bank and the World Trade Organization

took part in the event.

Many U.S. cattlemen support the change because it more accurately reflects the scientific knowledge surrounding the

disease.

“Scientists have determined that BSE is caused by feeding contaminated animal-based feed to cattle, and that cattle are

most likely to become infected with BSE during the first year of their lives, so using the infected animal’s birth date as

a reference point allows countries to determine how recently contaminated feed may have been circulating within their

feed system,” said Bill Bullard, CEO of R-CALF USA, a cattle industry association.

A ban on feeding animal tissues to cattle was imposed in the United States and Canada in 1997.

snip...

http://www.ens-newswire.com/ens/may2006/2006-05-31-02.asp

FEED BAN, what feed ban ???

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II

______________________________

PRODUCT

a) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals,

Recall # V-079-6;

b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg),

Recall # V-080-6;

c) PRO-PAK, MARINE & ANIMAL PROTEIN CONCENTRATE FOR USE IN ANIMAL

FEED, Recall # V-081-6;

d) Feather Meal, Recall # V-082-6

CODE

a) Bulk

b) None

c) Bulk

d) Bulk

RECALLING FIRM/MANUFACTURER

H. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 and by press release on June 16, 2006. Firm

initiated recall is ongoing.

REASON

Possible contamination of animal feeds with ruminent derived meat and bone meal.

VOLUME OF PRODUCT IN COMMERCE

10,878.06 tons

DISTRIBUTION

***Nationwide***

Page 87 of 98

8/3/2006

END OF ENFORCEMENT REPORT FOR July 12, 2006

###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html

Subject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006

Date: June 27, 2006 at 7:42 am PST

Public Health Service

Food and Drug Administration

New Orleans District

297 Plus Park Blvd.

Nashville, TN 37217

Telephone: 615-781-5380

Fax: 615-781-5391

May 17, 2006

WARNING LETTER NO. 2006-NOL-06

FEDERAL EXPRESS

OVERNIGHT DELIVERY

Mr. William Shirley, Jr., Owner

Louisiana.DBA Riegel By-Products

2621 State Street

Dallas, Texas 75204

Dear Mr. Shirley:

On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration (FDA) investigator inspected your

rendering plant, located at 509 Fortson Street, Shreveport, Louisiana. The inspection revealed significant deviations

from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 [21 CFR 589.2000], Animal

Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of

Bovine Spongiform Encephalopathy (BSE). You failed to follow the requirements of this regulation; products being

manufactured and distributed by your facility are misbranded within the meaning of Section 403(a)(1) [21 USC 343(a)

(1)] of the Federal Food, Drug, and Cosmetic Act (the Act).

Our investigation found you failed to provide measures, including sufficient written procedures, to prevent

commingling or cross-contamination and to maintain sufficient written procedures [21 CFR 589.2000(e)] because:

You failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from

mammalian tissues into animal protein or feeds which may be used for ruminants. For example, your facility uses the

same equipment to process mammalian and poultry tissues. However, you use only hot water to clean the cookers

Page 88 of 98

8/3/2006

between processing tissues from each species. You do not clean the auger, hammer mill, grinder, and spouts after

processing mammalian tissues.

You failed to maintain written procedures specifying the clean-out procedures or other means to prevent carryover of

protein derived from mammalian tissues into feeds which may be used for ruminants.

As a result . the poultry meal you manufacture may contain protein derived from mammalian tissues prohibited in

ruminant feed. Pursuant to 21 CFR 589.2000(e)(1)(i), any products containing or may contain protein derived from

mammalian tissues must be labeled, "Do not feed to cattle or other ruminants." Since you failed to label a product

which may contain protein derived from mammalian tissues with the required cautionary statement. the poultry meal is

misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the Act.

This letter is not intended as an all-inclusive list of violations at your facility. As a manufacturer of materials intended

for animal feed use, you are responsible for ensuring your overall operation and the products you manufacture and

distribute are in compliance with the law. You should take prompt action to correct these violations, and you should

establish a system whereby violations do not recur. Failure to promptly correct these violations may result in regulatory

action, such as seizure and/or injunction, without further notice.

You should notify this office in writing within 15 working days of receiving this letter, outlining the specific steps you

have taken to bring your firm into compliance with the law. Your response should include an explanation of each step

taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working

days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any

available documentation demonstrating corrections have been made.

Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S. Food and Drug Administration, 2424

Edenborn Avenue, Suite 410, Metairie, Louisiana 70001. If you have questions regarding any issue in this letter, please

contact Mr. Rivero at (504) 219-8818, extension 103.

Sincerely,

/S

Carol S. Sanchez

Acting District Director

New Orleans District

http://www.fda.gov/foi/warning_letters/g5883d.htm

WHY still now only partial ruminant feed ban, with the fact that now we seem to have 3 cases of nvCJD to humans i.e.

humanbovineTSE that were responsible from blood, and the fact the last 2 mad cows documented in the USA were that

of an Atypical strain, would it not seem prudent to remove blood as well from ruminant feed ?

WOULD it not seem prudent to improve and expand the SRM list now? as per your own thinking ;

> If transmission occurs, tissue distribution comparisons will be made between cattle

Page 89 of 98

8/3/2006

> infected with the atypical BSE isolate and the U.S. BSE isolate. Differences in

> tissue distribution could require new regulations regarding specific risk material

> (SRM) removal.

FULL text ;

Research Project: Study of Atypical Bse

Location: Virus and Prion Diseases of Livestock

Project Number: 3625-32000-073-07

Project Type: Specific C/A

Start Date: Sep 15, 2004

End Date: Sep 14, 2007

Objective:

The objective of this cooperative research project with Dr. Maria Caramelli from the Italian BSE Reference Laboratory

in Turin, Italy, is to conduct comparative studies with the U.S. bovine spongiform encephalopathy (BSE) isolate and

the atypical BSE isolates identified in Italy. The studies will cover the following areas: 1. Evaluation of present

diagnostics tools used in the U.S. for the detection of atypical BSE cases. 2. Molecular comparison of the U.S. BSE

isolate and other typical BSE isolates with atypical BSE cases. 3. Studies on transmissibility and tissue distribution of

atypical BSE isolates in cattle and other species.

Approach:

This project will be done as a Specific Cooperative Agreement with the Italian BSE Reference Laboratory, Istituto

Zooprofilattico Sperimentale del Piemonte, in Turin, Italy. It is essential for the U.S. BSE surveillance program to

analyze the effectiveness of the U.S diagnostic tools for detection of atypical cases of BSE. Molecular comparisons of

the U.S. BSE isolate with atypical BSE isolates will provide further characterization of the U.S. BSE isolate.

Transmission studies are already underway using brain homogenates from atypical BSE cases into mice, cattle and

sheep. It will be critical to see whether the atypical BSE isolates behave similarly to typical BSE isolates in terms of

transmissibility and disease pathogenesis. If transmission occurs, tissue distribution comparisons will be made between

cattle infected with the atypical BSE isolate and the U.S. BSE isolate. Differences in tissue distribution could require

new regulations regarding specific risk material (SRM) removal.

http://www.ars.usda.gov/research/projects/projects.htm?ACCN_NO=408490

HOWEVER, JAPAN has already shown infectivity in tissues other than CNS in there atypical TSE in cattle, so why

should we wait, and expose many to this agent needlessly, since the last two mad cows in the USA were also atypical

TSE ?

Page 90 of 98

8/3/2006

PrPSc distribution of a natural case of bovine spongiform encephalopathy

Yoshifumi Iwamaru, Yuka Okubo, Tamako Ikeda, Hiroko Hayashi, Mori- kazu Imamura, Takashi Yokoyama and

Morikazu Shinagawa

Priori Disease Research Center, National Institute of Animal Health, 3-1-5 Kannondai, Tsukuba 305-0856 Japan

gan@affrc.go.jp

Abstract

Bovine spongiform encephalopathy (BSE) is a disease of cattle that causes progressive neurodegeneration of the central

nervous system. Infectivity of BSE agent is accompanied with an abnormal isoform of prion protein (PrPSc).

The specified risk materials (SRM) are tissues potentially carrying BSE infectivity. The following tissues are

designated as SRM in Japan: the skull including the brain and eyes but excluding the glossa and the masse- ter muscle,

the vertebral column excluding the vertebrae of the tail, spinal cord, distal illeum. For a risk management step, the use

of SRM in both animal feed or human food has been prohibited. However, detailed PrPSc distribution remains obscure

in BSE cattle and it has caused controversies about definitions of SRM. Therefore we have examined PrPSc

distribution in a BSE cattle by Western blotting to reassess definitions of SRM.

The 11th BSE case in Japan was detected in fallen stock surveillance. The carcass was stocked in the refrigerator. For

the detection of PrPSc, 200 mg of tissue samples were homogenized. Following collagenase treatment, samples were

digested with proteinase K. After digestion, PrPSc was precipitated by sodium phosphotungstate (PTA). The pellets

were subjected to Western blotting using the standard procedure. Anti-prion protein monoclonal antibody (mAb) T2

conjugated horseradish peroxidase was used for the detection of PrPSc.

PrPSc was detected in brain, spinal cord, dorsal root ganglia, trigeminal ganglia, sublingual ganglion, retina. In

addition, PrPSc was also detected in the peripheral nerves (sciatic nerve, tibial nerve, vagus nerve).

Our results suggest that the currently accepted definitions of SRM in BSE cattle may need to be reexamined.

T. Kitamoto (Ed.)PRIONSFood and Drug Safety================

ALSO from the International Symposium of Prion Diseases held in Sendai, October 31, to November 2, 2004;

Bovine spongiform encephalopathy (BSE) in Japan

snip...

"Furthermore, current studies into transmission of cases of BSE that are atypical or that develop in young cattle are

expected to amplify the BSE prion"

NO. Date conf. Farm Birth place and Date Age at diagnosis

8. 2003.10.6. Fukushima Tochigi 2001.10.13. 23

9. 2003.11.4. Hiroshima Hyogo 2002.1.13. 21

Test results

# 8b, 9c cows Elisa Positive, WB Positive, IHC negative, histopathology negative

b = atypical BSE case

Page 91 of 98

8/3/2006

c = case of BSE in a young animal

b,c, No PrPSc on IHC, and no spongiform change on histology

International Symposium of Prion Diseases held in Sendai, October 31, to November 2, 2004.

Tetsuyuki Kitamoto Professor and Chairman Department of Prion Research Tohoku University School of Medicine 2-1

SeiryoAoba-ku, Sendai 980-8575, JAPAN TEL +81-22-717-8147 FAX +81-22-717-8148 e-mail;

kitamoto@mail.tains.tohoku.ac.jp Symposium Secretariat Kyomi Sasaki TEL +81-22-717-8233 FAX +81-22-717-7656

e-mail: kvomi-sasaki@mail.tains.tohoku.ac.ip

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

Atypical Proteinase K-Resistant Prion Protein (PrPres) observed in an Apparently Healthy 23-Month-Old Holstein

Steer

Jpn. J. Infect. Dis., 56, 221-222, 2003

Laboratory and Epidemiology Communications

Atypical Proteinase K-Resistant Prion Protein (PrPres) Observed in an Apparently Healthy 23-Month-Old Holstein

Steer

Yoshio Yamakawa*, KenÕichi Hagiwara, Kyoko Nohtomi, Yuko Nakamura, Masahiro Nishizima ,Yoshimi Higuchi1,

Yuko Sato1, Tetsutaro Sata1 and the Expert Committee for BSE Diagnosis, Ministry of Health, Labour and Welfare of

Japan2

Department of Biochemistry & Cell Biology and 1Department of Pathology, National Institute of Infectious Diseases,

Tokyo 162-8640 and 2Miistry of Health, Labour and Welfare, Tokyo 100-8916

Communicated by Tetsutaro Sata

(Accepted December 2, 2003)

*Corresponding author: Mailing address: Department of Biochemistry and Cell Biology, National Institute of

Infectious Diseases, Toyama 1-23-1, Shinjuku-ku, Tokyo 1628640, Japan. Tel: +81-3-5285-1111, Fax: +81-3-5285-

1157, E-mail: yamakawa@nih.go.jp

Since October 18, 2001, 'bovine spongiform encephalopathy (BSE) examination for all cattle slaughtered at abattoirs in

the country' has been mandated in Japan by the Ministry of Health, Labour and Welfare (MHLW). 'Plateria' ELISA-kit

(Bio-Rad Laboratories, Hercules, Calif., USA) is routinely used at abattoirs for detecting proteinase K (PK)-resistant

prion protein (PrPSc) in the obex region. Samples positive according to the ELISA screening are further subjected to

Western blot (WB) and histologic and immunohistochemical examination (IHC) at the National Institute of Infectious

Diseases (NIID) or Obihiro University. If PrPSc is detected either by WB or by IHC, the cattle are diagnosed as BSE.

The diagnosis is approved by the Expert Committee for BSE Diagnosis, MHLW. From October 18, 2001 to September

30, 2003, approximately 2.5 million cattle were screened at abattoirs. A hundred and ten specimens positive according

to ELISA were subjected to WB/IHC. Seven showed positive by both WB and IHC, all exhibiting the typical

electrophoretic profile of a high content of the di-glycosylated molecular form of PrPSc (1-3) and the distinctive

granular deposition of PrPSc in neuronal cells and neuropil of the dorsal nucleus of vagus.

An ELISA-positive specimen from a 23 month-old Holstein steer slaughtered on September 29, 2003, in Ibaraki

Page 92 of 98

8/3/2006

Prefecture (Ibaraki case) was sent to the NIID for confirmation. The animal was reportedly healthy before slaughter.

The OD titer in ELISA was slightly higher than the 'cut-off' level given by the manufacturer. The histology showed no

spongiform changes and IHC revealed no signal of PrPSc accumulation typical for BSE. However, WB analysis of the

homogenate that was prepared from the obex region and used for ELISA revealed a small amount of PrPSc with an

electrophoretic profile different from that of typical BSE-associated PrPSc (1-3). The characteristics were (i) low

content of the di-glycosylated molecular form of PrPSc, (ii) a faster migration of the non-glycosylated form of PrPSc

on SDS-PAGE, and (iii) less resistance against PK digestion as compared with an authentic PrPSc specimen derived

from an 83-month-old Holstein (Wakayama case) (Fig. 1). Table 1 summarizes the relative amounts of three distinctive

glycoforms (di-, mono, non-glycosylated) of PrPSc calculated by densitometric analysis of the blot shown in Fig. 1. As

2.5 mg wet weight obex-equivalent homogenate of the Ibaraki case (Fig. 1, lane 4) gave slightly stronger band

intensities of PrPSc than an 8 mg wet weight obex-equivqlent homogenate of a typical BSE-affected Wakayama case

(Fig. 1, lane 2), the amount of PrPSc accumulated in the Ibaraki case was calculated to be 1/500 - 1/1000 of the

Wakayama case. In the Ibaraki case, the PrPSc bands were not detectable in the homogenates of the proximal

surrounding region of the obex. These findings were consistent with the low OD value in ELISA, i.e., 0.2 -0.3 for the

Ibaraki case versus over 3.0 for the Wakayama case. The DNA sequence of the PrP coding region of the Ibaraki case

was the same as that appearing in the database (GenBank accession number: AJ298878). More recently, we

encountered another case that resembled the Ibaraki case. It was a 21-monthold Holstein steer from Hiroshima

Prefecture. WB showed typical BSE-specific PrPSc deposition though IHC did not detect positive signals of PrPSc

(data not shown).

Though the clinical onset of BSE is usually at around 5 years of age or later, a 20-month-old case showing the clinical

signs has been reported (4). Variant forms of BSE similar to our cases, i.e., with atypical histopathological and/or

biochemical phenotype, have been recently reported in Italy (5) and in France (6). Such variant BSE was not associated

with mutations in the prion protein (PrP) coding region as in our case (5,6).

The Ministry of Agriculture, Forestry and Fisheries of Japan (MAFF) announced a ban of feeding ruminants with meat

bone meal (MBM) on September 18, 2001, and a complete ban was made on October 15 of the same year. According

to the recent MAFF report, the previous seven cases of BSE in Japan were cattle born in 1995 - 1996 and possibly fed

with cross-contaminated feed. However, the two cattle in this report were born after the complete ban. Whether

contaminated MBM was implicated in the present cases remains to be investigated.

REFERENCES

Collinge, J., Sidle, K. C. L., Meads, J., Ironside, J. and Hill, A. F. (1996): Molecular analysis of prion strain variation

and the aetiology of 'new variant' CJD. Nature, 383, 685

690. Bruce, M. E., Will, R. G., Ironside, J. W., McConnell, I., Drummond, D., Suttie, A., McCardle, L., Chree, A.,

Hope, J., Birkett, C., Cousens, S., Fraser, H. and Bostock, C. J. (1997): Transmissions to mice indicate that 'new

variant' CJD is caused by the BSE agent. Nature, 389, 498-501. Hill, A. F., Desbruslais, M., Joiner, S., Sidle, K. C. L.,

Gowland, I. and Collinge, J. (1997): The same prion strain causes vCJD and BSE. Nature, 389, 448-450. Matravers,

W., Bridgeman, J. and Smith, M.-F. (ed.)(2000): The BSE Inquiry. p. 37. vol. 16. The Stationery Office Ltd., Norwich,

UK. Casalone, C., Zanusso, G., Acutis, P. L., Crescio, M. I., Corona, C., Ferrari, S., Capobianco, R., Tagliavini, F.,

Monaco, S. and Caramelli, M. (2003): Identification of a novel molecular and neuropathological BSE phenotype in

Italy. International Conference on Prion Disease: from basic research to intervention concepts. Gasreig, Munhen,

October 8-10. Bicaba, A. G., Laplanche, J. L., Ryder, S. and Baron, T. (2003): A molecular variant of bovine

spongiform encephalopatie. International Conference on Prion Disease: from basic research to intervention concepts.

Gasreig, Munhen, October 8-10. Asante, E. A., Linehan, J. M., Desbruslais, M., Joiner, S., Gowland, I., Wood, A. L.,

Welch, J., Hill, A. F., Lloyd, S. E., Wadsworth, J. D. F. and Collinge, J. (2002). BSE prions propagate as either variant

CJD-like or sporadic CJD-like prion strains in transgenic mice expressing human prion protein. EMBO J., 21, 6358-

6366.

Page 93 of 98

8/3/2006

9/13/2005

Page 12 of 17

SEE SLIDES IN PDF FILE;

http://www.nih.go.jp/JJID/56/221.pdf

http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf

4. WHAT does USDA/FDA ET AL intend to do about the risks of atypical BSE/TSE in cattle now that infectivity

shows in tissue samples other than CNS in Japan, the fact now that the last Texas mad cow and that last mad cow in

Alabama were indeed of the atypical strain, the fact that the studies long ago in Mission, Texas of USA sheep scrapie

transmission to the USA bovine, which proved an 'atypical tse' in the USA bovine, the fact also that USDA/FDA are

still floundering on the last SRM regulations, but with the BASE strain now in cattle that is not similar to nvCJD, but

very similar to the sporadic CJD, and sporadic CJD has tripled in the last few years in the USA. WHAT do you plan to

do to protect human health from these atypical strains of TSE, in relations to SRMs ?

5. THE 2004 Enhanced BSE surveillance program, that tested all those cows, but then we found just how terribly

flawed the program was, from testing protocols, to testing the most likely to have BSE i.e. high risk, to the

geographical distribution of the testing and high risk areas, to letting the tissue samples of one mad cow sit on a shelf

for 7+ months and then having to have an act of Congress to ever get that cow finally confirmed, to that other Texas

mad cow they decided to not even bother testing at all, just rendered that very suspect cow, to suspect to test evidently,

back to that Alabama mad cow that they could only give a guess as to age with dentition where we all know that the

age of that cow was so close to 10 years it could have been 9 years 7 months to 10 years 3 months, thus possibly being

an BAPB i.e. USA 'born after partial ban', to all those rabies suspect cows that did not have rabies, and DID NOT get

tested for BSE/TSE in that June 2004 enhanced surveillance program, even though the common lay person knows the

suspect rabies negative cows are suppose to be BSE/TSE tested, how does one correct all these blatant failures and will

they be corrected?

IT never was about human/animal health, but all about commodities and futures. ... MISSION ACCOMPLISHED $$$

ENFAMOUS NON-SPECIES CODING SYSTEM BY FDA ET AL, another handy tool for importing/exporting all

strains of TSE ;

Docket Management

Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305

Comment Number: EC -254

Accepted - Volume 11

Page 94 of 98

8/3/2006

http://www.fda.gov/OHRMS/DOCKETS/DOCKETS/02n0276/02N-0276-EC-254.htm

ONE FINAL THOUGHT ;

OPINION

http://www.efsa.eu.int/science/biohaz/biohaz_opinions/1540/biohaz_op_ej359_qra_vertebral_column_en1.pdf

>>>New methodology, under the auspices of the OIE, is

under construction within the EU and EFSA and the Panel recommended that once these

classifications had been finalised they should harmonised with those used in the EFSA

BSE QRA guidance document. The Panel anticipated that this harmonisation may have a

knock-on impact on the QRA calculations, conclusions and recommendations and that,

again, future Panel members should review this, and other, inputs of the QRA and address

this impact using their “self-tasking mandate” option.<<<

GOD HELP US!

sample survey via oie for bse is about 400 test via 100 million cattle, if i am not mistaken. MOST countries that went

by these OIE guidelines all eventually went down with BSE. ...TSS

http://www.oie.int/downld/SC/2005/bse_2005.pdf

THE OIE has now shown they are nothing more than a National Trading Brokerage for all strains of animal TSE.

AS i said before, OIE should hang up there jock strap now, since it appears they will buckle every time a country

makes some political hay about trade protocol, commodities and futures. IF they are not going to be science based, they

should do everyone a favor and dissolve there organization. ...

Page 95 of 98

8/3/2006

WHAT ABOUT RISK FACTORS TO HUMANS FROM ALL OTHER TSEs, WITH RELATIONS TO SRMs ???

a.. BSE OIE

see full text ;

http://p079.ezboard.com/fwolftracksproductionsfrm2.showMessage?topicID=470.topic

IT'S as obvious as day and night, either Larry, Curley, and Mo have been at the helm of the

USDA/APHIS/FSIS/FDA/CDC/NIH et al for many many years, or the incompetence of these agencies are so inept,

either through ignorance and or just too overweight with industry reps., they then should be all done away with and a

single agency brought forth, and if not, how will you correct this ongoing problem ?

Thank you,

I am sincerely disgusted,

Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518

http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf

EVERYONE OUT THERE THAT IS READING THIS SHOULD SUBMIT TO THIS DOCKET. ...TSS

CDC DR. PAUL BROWN TSE EXPERT COMMENTS 2006

The U.S. Department of Agriculture was quick to assure the public earlier this week that the third case of mad cow disease did not pose a risk to them, but what federal officials have not acknowledged is that this latest case indicates the deadly disease has been circulating in U.S. herds for at least a decade.

The second case, which was detected last year in a Texas cow and which USDA officials were reluctant to verify, was approximately 12 years old.

These two cases (the latest was detected in an Alabama cow) present a picture of the disease having been here for 10 years or so, since it is thought that cows usually contract the disease from contaminated feed they consume as calves. The concern is that humans can contract a fatal, incurable, brain-wasting illness from consuming beef products contaminated with the mad cow pathogen.

"The fact the Texas cow showed up fairly clearly implied the existence of other undetected cases," Dr. Paul Brown, former medical director of the National Institutes of Health's Laboratory for Central Nervous System Studies and an expert on mad cow-like diseases, told United Press International. "The question was, 'How many?' and we still can't answer that."

Brown, who is preparing a scientific paper based on the latest two mad cow cases to estimate the maximum number of infected cows that occurred in the United States, said he has "absolutely no confidence in USDA tests before one year ago" because of the agency's reluctance to retest the Texas cow that initially tested positive.

USDA officials finally retested the cow and confirmed it was infected seven months later, but only at the insistence of the agency's inspector general.

"Everything they did on the Texas cow makes everything USDA did before 2005 suspect," Brown said. ...snip...end

http://www.upi.com/ConsumerHealthDaily/view.php?StoryID=20060315-055557-1284r

*** Inherent Challenges in Identifying and Testing High-Risk Cattle Still Remain

http://www.usda.gov/oig/webdocs/50601-10-KC.pdf

[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)

http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf

[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk
Materials for Human Food and Requirement for the Disposition of
Non-Ambulatory Disabled Cattle

03-025IFA
03-025IFA-2

http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf

THE SEVEN SCIENTIST REPORT ***

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf

SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM
1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype
of 'UNKNOWN' strain growing. ...


http://www.cjdsurveillance.com/resources-casereport.html


There is a growing number of human CJD cases, and they were presented last week in San Francisco by Luigi Gambatti(?) from his CJD surveillance collection.

He estimates that it may be up to 14 or 15 persons which display selectively SPRPSC and practically no detected RPRPSC proteins.

http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm


http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf

Full Text

Diagnosis and Reporting of Creutzfeldt-Jakob Disease

Singeltary, Sr et al. JAMA.2001; 285: 733-734.

http://jama.ama-assn.org/cgi/content/full/285/6/733?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=dignosing+and+reporting+creutzfeldt+jakob+disease&searchid=1048865596978_1528&stored_search=&FIRSTINDEX=0&journalcode=jama

http://www.neurology.org/cgi/eletters/60/2/176#535

BRITISH MEDICAL JOURNAL

BMJ

http://www.bmj.com/cgi/eletters/319/7220/1312/b#EL2

BMJ

http://www.bmj.com/cgi/eletters/320/7226/8/b#EL1

Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518






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