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From: TSS ()
Subject: FSIS NOTICE SAMPLE COLLECTION FROM CATTLE UNDER THE BOVINE SPONGIFORM ENCEPHALOPATHY (BSE) ONGOING SURVEILLANCE PROGRAM
Date: February 2, 2007 at 2:35 pm PST

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE WASHINGTON, DC

08-07

2/2/2007

FSIS NOTICE

SAMPLE COLLECTION FROM CATTLE UNDER THE BOVINE SPONGIFORM ENCEPHALOPATHY (BSE) ONGOING SURVEILLANCE PROGRAM

I. PURPOSE

This notice provides the Food Safety and Inspection Service (FSIS) inspection program personnel with instructions regarding the collection of brain samples for the Animal and Plant Health Inspection Service’s (APHIS) Bovine Spongiform Encephalopathy (BSE) ongoing surveillance plan. This notice cancels FSIS Notice 51-06, Sample Collection from Cattle under the Bovine Spongiform Encephalopathy (BSE) Ongoing Surveillance Program, and FSIS Notice 52-06, Temporary Suspension of Provision in the Bovine Spongiform Encephalopathy (BSE) Ongoing Surveillance Program. FSIS has incorporated the pertinent information from the cancelled notices into this notice. This revised notice is a result of changes APHIS has made to its surveillance plan.

II. DEFINITION OF NEW COLLECTION PROCEDURES

A. Approved Alternative Off-Site Sample Collection

1. APHIS will provide for the collection of brain (obex) samples from an allocated number of cattle 30 months and older condemned for any reason on ante-mortem inspection, and from cattle of any age displaying Central Nervous System (CNS) symptoms, at federally-inspected slaughter establishments that have agreements with APHIS under the approved alternative off-site sample collection program.
2. At such establishments, FSIS inspection program personnel will not collect brain samples. They will provide the following to plant management:
a. condemn tag (Z-tag) numbers (not the Z-tag itself); and

b. disposition information (i.e., the reason for condemnation under 9 CFR Part 309).

DISTRIBUTION: Inspection Offices;

NOTICE EXPIRES: 3/1/08

OPI: OPPED

T/A Inspectors; TSC; Import Offices

B. Brain Sample Collection of Cattle Displaying CNS Symptoms

1. At Federally-inspected establishments not under the approved alternative off-site sample collection program, FSIS Public Health Veterinarians (PHVs):

a. will collect appropriate BSE samples from cattle of all ages that display CNS symptoms, or
b. will not collect the samples for BSE testing if the slaughter establishment has made or plans to make arrangements with APHIS, whereby the samples from cattle condemned for CNS symptoms will be collected at a location other than on the official plant premises.
NOTE: Certain Alternative Off-Site Agreements that were in place during Enhanced Surveillance may no longer be in effect and establishments will need to initiate new agreements with APHIS and potential collectors.

III. FSIS PERSONNEL RESPONSIBILITIES
A. Upon receipt of this notice, the FSIS PHV is to hold an awareness meeting with the establishment. At this meeting, the FSIS PHV should ask the management whether:
1. it is under APHIS’ approved alternative off-site sample collection program for collecting allocated samples (paragraph II. A.); and

2. if not, whether:

a. FSIS is to collect brain samples from cattle displaying CNS symptoms (paragraph II. B. 1.a.); or
b. the establishment needs time to engage in making arrangements with APHIS for the off-site brain sample collection of such cattle (paragraph II. B. 1. b.).
B. If during the awareness meeting establishment management states that it plans to work with APHIS to begin off-site sampling, until APHIS approves that arrangement, or until FSIS is advised that an off-site agreement will not be forthcoming, FSIS PHVs are to:
1. identify all CNS animals condemned on ante-mortem with a "U. S. Condemned" tag;
2. contact the APHIS Area Veterinarian-In-Charge (AVIC) so the AVIC can collect the brain sample;
3. ensure that the animals are humanely euthanized, unless APHIS requests otherwise; and
2

FSIS NOTICE 08-07
4. not allow them to move off the premise of the establishment, unless APHIS requests otherwise.
C. In a memorandum of interview (MOI), the FSIS PHV is to document who was present at the awareness meeting, the date and time of the meeting, how the establishment plans to proceed based on the choices set out in A. above, and any documents shared with management.

D. If the establishment plans to work with APHIS to begin off-site sampling, the FSIS PHV is to update the MOI as to whether an agreement was reached and in general, what the agreement was.

E. The FSIS PHV is to maintain a copy of the memorandum of interview in the official government file, provide a copy to the plant management, and electronically mail a copy to the APHIS AVIC as changes occur.

IV. FSIS RESPONSIBILITIES RELATED TO APPROVED ALTERNATIVE OFFSITE SAMPLE COLLECTION
A. The FSIS PHV is to complete the condemnation form, FSIS Form 6000-13 (Certification of Ante-mortem or Post-mortem Disposition of Tagged Animals) and FSIS Form 6150-1 (Identification Tag – Ante-mortem). The FSIS PHV should pay special attention when providing a full description of the reason for the condemnation on FSIS Form 6000-13 and fill out fully FSIS Form 6150-1.
B. Incoming animal identification, except the Z-tag, should be left on these animals since it will be needed at the approved alternative off-site collection location to fill out collection forms. Z-tags will be removed prior to any carcasses leaving the official establishment.
NOTE: Information supplied to plant management to take to the approved alternative off-site collection sites needs to be complete and accurate. FSIS PHVs need to provide a full description of the reason for the condemnation on FSIS Form 6000-13, APHIS will use this information to triage which condemned animals are sampled.

V. FSIS SAMPLE COLLECTION FOR CATTLE DISPLAYING CNS SYMPTOMS

A. If the establishment does not have an agreement with APHIS for off-site sampling of cattle with CNS symptoms, the FSIS PHV will collect the brain samples from cattle showing signs of CNS symptoms. The FSIS PHV is to make all final disposition decisions regarding whether to condemn cattle in accordance with 9 CFR part 309.

NOTE: FSIS PHVs can also find information regarding BSE sampling (e.g., forms, sampling supply information) at:

Public Folders/All Public Folders/OFO/Technical Service Center/BSE Training Info

3

B. The FSIS PHV, or the establishment under the supervision of the FSIS PHV, should promptly remove the head in order to collect the brain sample. If the establishment does not arrange to remove the head, the FSIS PHV may need to collect the brain sample as a priority over other ante-mortem or post-mortem procedures.

C. The FSIS PHV should collect the brain sample either in the inedible area of the establishment or in another area set aside for such collection to prevent the creation of an insanitary condition. Establishment personnel and FSIS inspection program personnel are to take proper sanitary measures before returning to edible areas of the establishment after brain sample collection, in accordance with 9 CFR 416.5.

D. In situations where the FSIS PHV has missed the last FedEx pick-up for the day, or the FSIS PHV collected the sample on a day when FedEx does not pick up, the PHV is to refrigerate the samples until the next available FedEx pick-up day. Remember, the sample is not to pass through or to be stored in areas of the establishment where the establishment produces edible product. The FSIS PHV is to maintain the sample’s chain-of-custody.

E. The FSIS PHV is to verify the collection, documentation, and control of all animal identification associated with cattle condemned during ante-mortem inspection that are to be sampled by FSIS. The FSIS PHV is to attach the "U. S. Condemned" tag to cattle condemned during ante-mortem inspection in accordance with 9 CFR 309.13. This documentation will facilitate traceback in the event that the sample result is positive for BSE. The documentation should include records in accordance with 9 CFR 320.1.

F. The FSIS PHV is to verify that the presence of condemned cattle or parts does not create insanitary conditions (9 CFR part 416). The establishment is responsible for the disposal of the condemned cattle in accordance with 9 CFR part

314. The FSIS PHV also is to verify that the establishment maintains records regarding the disposal of the condemned cattle in accordance with 9 CFR 320.1.

G. Inspection program personnel may inform the establishment that it may choose to hold the carcass and parts until testing results are available. If the establishment chooses to dispose of any carcass or parts before it receives test results, inspection program personnel are to advise the establishment that it must dispose of the carcass in one of the following ways:

1. render it at a facility for non-animal feed use (e.g., biofuel or cement);
2. alkaline digestion;
3. incineration; or
4. lined land fills.
H. Documentation for Cattle Showing Signs of CNS Symptoms

1. For locations without high-speed internet connections, the FSIS PHV is to forward the completed BSE Surveillance Information System (BSE-SIS) sample

4

FSIS NOTICE 08-07

collection sheets to the APHIS,VS office by FAX or by e-mail. The follow site lists the VS office FAX numbers and e-mail where available:

http://www.aphis.usda.gov/vs/area_offices.htm

The APHIS AVIC in each area office may assist with sample delivery verification and troubleshooting. The FSIS PHV can get copies of BSE-SIS forms by contacting the local APHIS office.

2. The FSIS PHV is to enter the relevant information into the BSE-SIS at locations with high-speed connections and proceed as instructed in the training materials. FSIS PHVs may get the training from AgLearn or may contact the District Office if they need a copy of the BSE Surveillance Information System (BSE-SIS) training CD and for assistance in getting permission to have access to BSE-SIS.

VI. TEST RESULTS FOR FSIS SAMPLING FROM CATTLE SHOWING CNS SYMPTOMS

The FSIS PHV will receive, by e-mail, a report from the AVIC on the BSE test results. The AVIC will also send copies of the results to the District Office.

1. If the test is negative (reported as "not detected"), any carcasses and parts the establishment has held may be released for rendering or other disposal in accordance with 9 CFR 314.
2. If the test is inconclusive, the FSIS PHV will receive supervisory instruction on further actions.
3. For any sample confirmed positive for BSE, the FSIS PHV is to verify that the establishment disposes of the carcasses and parts in the proper manner as set out in paragraph V. G.
VII. eADRS PROCEDURES FOR FSIS SAMPLING FROM CATTLE SHOWING CNS SYMPTOMS

After sampling cattle showing signs of CNS symptoms, the FSIS PHV (or designee) is to enter the relevant information for each sample into eADRS.

1. The FSIS PHV (or designee) is to enter each ante-mortem condemned animal in eADRS under the applicable pathological condition.
2. For each relevant disease condition, in the "Add Daily Totals" window, the FSIS PHV is to select the "Update BSE Details" button if FSIS sampled one or more of the condemned animals for BSE. Selecting this button opens the "Update BSE Details" screen.
3. On the "Update BSE Details" screen, the FSIS PHV is to enter the number of

5

animals sampled and the applicable "U.S. Condemned" Z-tag number for each sampled

animal.

4. After entering the relevant information, the FSIS PHV is to click the "Save" button and proceed to the next disease condition.

For additional information on entering BSE sample information, refer to Section 7 of the eADRS User Guide.

VIII. RABIES

In a rare situation, such as when an animal is condemned by the FSIS PHV on antemortem for rabies, the FSIS PHV should contact their District Office, who will advise APHIS. In these cases, APHIS will see that the animal is tested for rabies. APHIS will work with the laboratory to get appropriate samples forwarded for BSE surveillance from rabies negative animals.

Rabies vaccination of FSIS collectors is still highly recommended. The voluntary rabies vaccination program details are covered in FSIS Notice 29-04, Questions and Answers for FSIS Notice 28-04 Regarding Ante-Mortem Condemned Cattle.

Refer questions to the Technical Assistance and Correlation Division, Technical Service Center, at 1-800-233-3935.

Assistant Administrator Office of Policy, Program, and Employee Development

6

http://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/08-07.pdf

FOR IMMEDIATE RELEASE
Statement
May 4, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

Statement on Texas Cow With Central Nervous System Symptoms
On Friday, April 30 th , the Food and Drug Administration learned that a cow with central nervous system symptoms had been killed and shipped to a processor for rendering into animal protein for use in animal feed.

FDA, which is responsible for the safety of animal feed, immediately began an investigation. On Friday and throughout the weekend, FDA investigators inspected the slaughterhouse, the rendering facility, the farm where the animal came from, and the processor that initially received the cow from the slaughterhouse.

FDA's investigation showed that the animal in question had already been rendered into "meat and bone meal" (a type of protein animal feed). Over the weekend FDA was able to track down all the implicated material. That material is being held by the firm, which is cooperating fully with FDA.

Cattle with central nervous system symptoms are of particular interest because cattle with bovine spongiform encephalopathy or BSE, also known as "mad cow disease," can exhibit such symptoms. In this case, there is no way now to test for BSE. But even if the cow had BSE, FDA's animal feed rule would prohibit the feeding of its rendered protein to other ruminant animals (e.g., cows, goats, sheep, bison).

FDA is sending a letter to the firm summarizing its findings and informing the firm that FDA will not object to use of this material in swine feed only. If it is not used in swine feed, this material will be destroyed. Pigs have been shown not to be susceptible to BSE. If the firm agrees to use the material for swine feed only, FDA will track the material all the way through the supply chain from the processor to the farm to ensure that the feed is properly monitored and used only as feed for pigs.

To protect the U.S. against BSE, FDA works to keep certain mammalian protein out of animal feed for cattle and other ruminant animals. FDA established its animal feed rule in 1997 after the BSE epidemic in the U.K. showed that the disease spreads by feeding infected ruminant protein to cattle.

Under the current regulation, the material from this Texas cow is not allowed in feed for cattle or other ruminant animals. FDA's action specifying that the material go only into swine feed means also that it will not be fed to poultry.

FDA is committed to protecting the U.S. from BSE and collaborates closely with the U.S. Department of Agriculture on all BSE issues. The animal feed rule provides crucial protection against the spread of BSE, but it is only one of several such firewalls. FDA will soon be improving the animal feed rule, to make this strong system even stronger.

####

http://www.fda.gov/bbs/topics/news/2004/NEW01061.html

[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

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

THE SEVEN SCIENTIST REPORT ***


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


PAUL BROWN M.D.

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf


9 December 2005
Division of Dockets Management (RFA-305)

SEROLOGICALS CORPORATION
James J. Kramer, Ph.D.
Vice President, Corporate Operations

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdf

Embassy of Japan
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02N-0273-EC240.htm

03-025IF 03-025IF-631 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-631 Linda A. Detwiler Page 2. Page 3. Page 4.
Page 5. Page 6. Page 7. Page 8. Page 9. Page 10. Page 11. Page 12.
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-631.pdf


03-025IF 03-025IF-634 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-634 Linda A. Detwiler Page 2.
Page 3. Page 4. Page 5. Page 6. Page 7. Page 8.
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-634.pdf


Page 1 of 17 9/13/2005 [PDF]
... 2005 6:17 PM To: fsis.regulationscomments@fsis.usda.gov Subject: [Docket
No. 03-025IFA]
FSIS Prohibition of the Use of Specified Risk Materials for Human Food ...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf

03-025IFA 03-025IFA-6 Jason Frost [PDF]
... Zealand Embassy COMMENTS ON FEDERAL REGISTER 9 CFR Parts 309 et al
[Docket No. 03-
025IF] Prohibition of the Use of Specified Risk Materials for Human Food and
...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-6.pdf


In its opinion of 7-8 December 2000 (EC 2000), the SSC ... [PDF]
Page 1. Linda A. Detwiler, DVM 225 Hwy 35 Red Bank, New Jersey 07701 Phone:
732-741-2290
Cell: 732-580-9391 Fax: 732-741-7751 June 22, 2005 FSIS Docket Clerk US ...

http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-589.pdf

18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7
December 2006 are now available.


snip...

64. A member noted that at the recent Neuroprion meeting, a study was
presented showing that in transgenic mice BSE passaged in sheep may be more
virulent and infectious to a wider range of species than bovine derived BSE.

Other work presented suggested that BSE and bovine amyloidotic spongiform
encephalopathy (BASE) MAY BE RELATED. A mutation had been identified in the
prion protein gene in an AMERICAN BASE CASE THAT WAS SIMILAR IN NATURE TO A
MUTATION FOUND IN CASES OF SPORADIC CJD.


snip...

http://www.seac.gov.uk/minutes/95.pdf


3:30 Transmission of the Italian Atypical BSE (BASE) in Humanized Mouse

Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western Reserve
University

Bovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE strain
discovered recently in Italy, and similar or different atypical BSE cases
were also reported in other countries. The infectivity and phenotypes of
these atypical BSE strains in humans are unknown. In collaboration with
Pierluigi Gambetti, as well as Maria Caramelli and her co-workers, we have
inoculated transgenic mice expressing human prion protein with brain
homogenates from BASE or BSE infected cattle. Our data shows that about half
of the BASE-inoculated mice became infected with an average incubation time
of about 19 months; in contrast, none of the BSE-inoculated mice appear to
be infected after more than 2 years.

***These results indicate that BASE is transmissible to humans and suggest that BASE is more virulent than
classical BSE in humans.***


6:30 Close of Day One


http://www.healthtech.com/2007/tse/day1.asp


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

THE USDA JUNE 2004 ENHANCED BSE SURVEILLANCE PROGRAM WAS TERRIBLY FLAWED ;


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/

CDC - Bovine Spongiform Encephalopathy and Variant Creutzfeldt ...
Dr. Paul Brown is Senior Research Scientist in the Laboratory of Central
Nervous System ... Address for correspondence: Paul Brown, Building 36, Room
4A-05, ...


http://www.cdc.gov/ncidod/eid/vol7no1/brown.htm

PAUL BROWN COMMENT TO ME ON THIS ISSUE

Tuesday, September 12, 2006 11:10 AM


"Actually, Terry, I have been critical of the USDA handling of the mad cow issue for some years, and with Linda Detwiler and others sent lengthy detailed critiques and recommendations to both the USDA and the Canadian Food Agency." ........TSS


BRITISH MEDICAL JOURNAL

SOMETHING TO CHEW ON

BMJ

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

BMJ

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


THE PATHOLOGICAL PROTEIN

BY Philip Yam


CHAPTER 14 LAYING ODDS

Answering critics like Terry Singeltary, who feels that the U.S. under-
counts CJD, Schonberger conceded that the current surveillance system
has errors but stated that most of the errors will be confined to the older
population.

http://www.thepathologicalprotein.com/

INTRODUCTION

http://www.thepathologicalprotein.com/_wsn/page3.html

Yam Philip Yam News Editor Scientific American www.sciam.com
http://www.thepathologicalprotein.com/


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


Journal of Neurology


Re: RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States


Email Terry S. Singeltary:


flounder9@verizon.net


I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to

comment on the CDC's attempts to monitor the occurrence of emerging

forms of CJD. Asante, Collinge et al [1] have reported that BSE

transmission to the 129-methionine genotype can lead to an alternate

phenotype that is indistinguishable from type 2 PrPSc, the commonest

sporadic CJD. However, CJD and all human TSEs are not reportable

nationally. CJD and all human TSEs must be made reportable in every

state and internationally. I hope that the CDC does not continue to

expect us to still believe that the 85%+ of all CJD cases which are

sporadic are all spontaneous, without route/source. We have many TSEs in

the USA in both animal and man. CWD in deer/elk is spreading rapidly and

CWD does transmit to mink, ferret, cattle, and squirrel monkey by

intracerebral inoculation. With the known incubation periods in other

TSEs, oral transmission studies of CWD may take much longer. Every

victim/family of CJD/TSEs should be asked about route and source of this

agent. To prolong this will only spread the agent and needlessly expose

others. In light of the findings of Asante and Collinge et al, there

should be drastic measures to safeguard the medical and surgical arena

from sporadic CJDs and all human TSEs. I only ponder how many sporadic

CJDs in the USA are type 2 PrPSc?


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

Tracking spongiform encephalopathies in North America

THE LANCET Infectious Diseases Vol 3 August 2003

http://www.thelancet.com/journals/laninf/article/PIIS1473309903007151/fulltext

http://download.thelancet.com/pdfs/journals/1473-3099/PIIS1473309903007151.pdf


Terry S. Singeltary SR.
P.O. Box 42
Bacliff, Texas USA 77518





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