Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease ( vCJD) USA JUNE, JULY, AUGUST 2012
Blood products, collected from a donor who was at risk for variant
Creutzfeldt-Jakob disease ( vCJD) USA JUNE, JULY, AUGUST 2012
Enforcement Report for June 13, 2012
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1583-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1584-12;
3) Cryoprecipitated AHF. Recall # B-1585-12;
4) Cryoprecipitated AHF, Pooled. Recall # B-1586-12;
5) Plasma Cryoprecipitated Reduced. Recall # B-1587-12
6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall #
B-1588-12;
7) Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated. Recall #
B-1589-12;
8) Fresh Frozen Plasma. Recall # B-1590-12;
9) Recovered Plasma. Recall # B-1591-12
CODE
1) Units: 1697475; 1652549; 1677134;
2) Units: 1683520; 1646887; 1608557; 1192475; 0952938; 0940117; 0920215;
0872595;
3) Unit: 1683520;
4) Units: 1646887; 1677134; 1608557;
5) Units: 1652549; 1646887;
6) Units: 1153405; 1138376; 1060176; 1005776; 1013230; 0955842;
7) Unit: 1104684;
8) Units: 1192475; 0952938; 0940117;
9) Units: 1697475; 1683520; 1677134; 1608557; 0920215; 0872595
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center University of Cincinnati Medical Center, Cincinnati,
OH, by telephone and letters dated October 19, 2006. Firm initiated recall is
complete.
REASON
Blood products, collected from a donor who was at risk for variant
Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
33 units
DISTRIBUTION
KY, OH
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-1471-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1472-12
CODE
1) and 2) Unit: 0886922
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by
telephone and e-mail on October 5, 2005.
Manufacturer: Blood Centers of the Pacific, Redding, CA. Firm initiated
recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk
for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA and Switzerland
___________________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1562-12
CODE
Unit: 42S18958
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Cleveland, OH, by telephone on July 11,
2007 and by letter dated July 19, 2007. Firm initiated recall is complete.
REASON Blood product, collected from a donor who was at risk for variant
Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
Enforcement Report for June 6, 2012
PRODUCT
Recovered Plasma. Recall # B-1477-12
CODE
Unit: W088411552400
RECALLING FIRM/MANUFACTURER
Blood Bank Of Hawaii, Honolulu, HI, by e-mail on March 13, 2012. Firm
initiated recall is complete.
REASON Blood product, collected from a donor considered to be at increased
risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
Enforcement Report - Week of July 25, 2012
Event Detail
Event ID 47718
Product Type Biologics
Status Terminated
Recalling Firm Coral Blood Services, Inc.
City Scarborough
State ME
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-03-11
Initial Firm Notification of
Consignee or Public Letter
Distribution Pattern ME
Product Detail
Product Description Code Info Classification Reason for Recall Product
Quantity Recall Number
Red Blood Cells (Apheresis) Leukocytes Reduced 7795181 Class II Blood
products, collected from a donor who was at risk for variant Creutzfeldt-Jakob
disease (vCJD), were distributed. 1 unit B-1428-12
Fresh Frozen Plasma 7795181 Class II Blood products, collected from a donor
who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
1 unit B-1429-12
Enforcement Report - Week of July 5, 2012
Event Detail
Event ID 61992
Product Type Biologics
Status Terminated
Recalling Firm Blood Assurance Inc
City Chattanooga
State TN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-01
Initial Firm Notification of
Consignee or Public FAX
Distribution Pattern TN, GA, NY
Product Detail
Product Description Code Info Classification Reason for Recall Product
Quantity Recall Number
Plasma Cryoprecipitated Reduced W043210088572 Class II Blood products,
collected from a donor who was at risk for variant Creutzfeldt-Jakob disease
(vCJD), were distributed. 1 unit B-2009-12
Red Blood Cells (Apheresis) Leukocytes Reduced W043211094961-A;
W043211094961-B; W043211044082-A; W043211025338-A; W043211044082-B;
W043211025338-B Class II Blood products, collected from a donor who was at risk
for variant Creutzfeldt-Jakob disease (vCJD), were distributed. 6 units
B-2010-12
Cryoprecipitated AHF, Pooled W043210088572 Class II Blood products,
collected from a donor who was at risk for variant Creutzfeldt-Jakob disease
(vCJD), were distributed. 1 unit B-2011-12
Red Blood Cells Leukocytes Reduced V89413; V26698; W043210088572;
W043210075817 Class II Blood products, collected from a donor who was at risk
for variant Creutzfeldt-Jakob disease (vCJD), were distributed. 4 units
B-2012-12
Plasma Frozen within 24 hours (FP24) W043210075817 Class II Blood products,
collected from a donor who was at risk for variant Creutzfeldt-Jakob disease
(vCJD), were distributed. 1 unit B-2013-12
Blood and Blood Products for Reprocessing V89413 Class II Blood products,
collected from a donor who was at risk for variant Creutzfeldt-Jakob disease
(vCJD), were distributed. 1 unit B-2014-12
Fresh Frozen Plasma V26698 Class II Blood products, collected from a donor
who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
1 unit B-2015-12
Enforcement Report - Week of August 15, 2012
Event Detail
Event ID 61992
Product Type Biologics
Status Terminated
Recalling Firm Blood Assurance Inc
City Chattanooga
State TN
Country US Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-01
Initial Firm Notification of
Consignee or Public FAX
Distribution Pattern TN, GA, NY
Product Detail
Product Description Code Info Classification Reason for Recall Product
Quantity Recall Number
Plasma Cryoprecipitated Reduced W043210088572 Class II Blood products,
collected from a donor who was at risk for variant Creutzfeldt-Jakob disease
(vCJD), were distributed. 1 unit B-2009-12
Red Blood Cells (Apheresis) Leukocytes Reduced W043211094961-A;
W043211094961-B; W043211044082-A; W043211025338-A; W043211044082-B;
W043211025338-B Class II Blood products, collected from a donor who was at risk
for variant Creutzfeldt-Jakob disease (vCJD), were distributed. 6 units
B-2010-12
Cryoprecipitated AHF, Pooled W043210088572 Class II Blood products,
collected from a donor who was at risk for variant Creutzfeldt-Jakob disease
(vCJD), were distributed. 1 unit B-2011-12
Red Blood Cells Leukocytes Reduced V89413; V26698; W043210088572;
W043210075817 Class II Blood products, collected from a donor who was at risk
for variant Creutzfeldt-Jakob disease (vCJD), were distributed. 4 units
B-2012-12
Plasma Frozen within 24 hours (FP24) W043210075817 Class II Blood products,
collected from a donor who was at risk for variant Creutzfeldt-Jakob disease
(vCJD), were distributed. 1 unit B-2013-12
Blood and Blood Products for Reprocessing V89413 Class II Blood products,
collected from a donor who was at risk for variant Creutzfeldt-Jakob disease
(vCJD), were distributed. 1 unit B-2014-12
Fresh Frozen Plasma V26698 Class II Blood products, collected from a donor
who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
1 unit B-2015-12
Monday, August 13, 2012
Summary results of the second national survey of abnormal prion prevalence
in archived appendix specimens August 2012
Friday, August 10, 2012
Incidents of Potential iatrogenic Creutzfeldt-Jakob disease (CJD) biannual
update (July 2012)
Tuesday, July 31, 2012
11 patients may have been exposed to fatal disease Creutzfeldt-Jakob
Disease CJD Greenville Memorial Hospital
Saturday, July 07, 2012
Class II, Blood products, collected from a donor who was at risk for
variant Creutzfeldt-Jakob disease ( vCJD) USA
Enforcement Report
Monday, June 11, 2012
Guidance for Industry Draft Guidance for Industry: Amendment to “Guidance
for Industry: Revised Preventive Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease
by Blood and Blood Products”
IN SHORT ;
“However, based on animal studies, as well as on FDA risk assessments, the
possibility of vCJD transmission by a U.S.-licensed plasma derivative, while
extremely small, cannot be absolutely ruled out. For these reasons, the
recommendations for labeling for plasma derivatives will include mention of vCJD
for the first time, and the potential risk for its transmission. The recommended
elements of the warning label for CJD are unchanged and continue to describe its
transmission as a theoretical risk, given that there is no confirmed evidence
that CJD is transmitted by blood (Refs. 4-7).“
IN FULL, as follows ;
Monday, June 11, 2012
Guidance for Industry Draft Guidance for Industry: Amendment to “Guidance
for Industry: Revised Preventive Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease
by Blood and Blood Products”
Friday, June 29, 2012
Highly Efficient Prion Transmission by Blood Transfusion
Sunday, June 3, 2012
A new neurological disease in primates inoculated with prion-infected blood
or blood components
Thursday, August 02, 2012
CJD case in Saint John prompts letter to patients Canada CJD case in Saint
John prompts letter to patients
Monday, July 23, 2012
The National Prion Disease Pathology Surveillance Center July 2012
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." flounder@wt.net
######### Bovine Spongiform Encephalopathy
#########
Greetings List Members,
I was lucky enough to sit in on this BSE conference call today and even
managed to ask a question. that is when the trouble started.
I submitted a version of my notes to Sandra Blakeslee of the New York
Times, whom seemed very upset, and rightly so.
"They tell me it is a closed meeting and they will release whatever
information they deem fit. Rather infuriating."
and i would have been doing just fine, until i asked my question. i was
surprised my time to ask a question so quick.
(understand, these are taken from my notes for now. the spelling of names
and such could be off.)
[host Richard Barns] and now a question from Terry S. Singeltary of CJD
Watch.
[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
from this point, i was still connected, got to listen and tape the whole
conference. at one point someone came on, a woman, and ask again;
[unknown woman] what group are you with?
[TSS] CJD Watch and my Mom died from hvCJD we are trying to tract down CJD
and other human TSE's world wide. i was invited to sit in on this from someone
inside the USDA/APHIS and that is why i am here. do you intend on banning me
from this conference now?
at this point the conference was turned back up, and i got to finish
listening. They never answered or even addressed my one question, or even
addressed the issue. BUT, i will try and give you a run-down for now, of the
conference.
IF i were another Country, I would take heed to my notes, BUT PLEASE do not
depend on them. ask for transcript from;
RBARNS@ORA.FDA.GOV 301-827-6906
he would be glad to give you one ;-)
Rockville Maryland, Richard Barns Host
BSE issues in the U.S., How they were labelling ruminant feed? Revising
issues.
The conference opened up with the explaining of the U.K. BSE epidemic
winding down with about 30 cases a week.
although new cases in other countries were now appearing.
Look at Germany whom said NO BSE and now have BSE.
BSE increasing across Europe.
Because of Temporary Ban on certain rendered product, heightened interest
in U.S.
A recent statement in Washington Post, said the New Administration (old GW)
has a list of issues. BSE is one of the issues.
BSE Risk is still low, minimal in U.S. with a greater interest in MBM not
to enter U.S.
HOWEVER, if BSE were to enter the U.S. it would be economically disastrous
to the render, feed, cattle, industries, and for human health.
(human health-they just threw that in cause i was listening. I will now jot
down some figures in which they told you, 'no need to write them down'. just
hope i have them correct. hmmm, maybe i hope i don't ???)
80% inspection of rendering
*Problem-Complete coverage of rendering HAS NOT occurred.
sizeable number of 1st time FAILED INITIAL INSPECTION, have not been
reinspected (70% to 80%).
Compliance critical, Compliance poor in U.K. and other European Firms.
Gloria Dunason Major Assignment 1998 goal TOTAL compliance. This _did not_
occur. Mixed level of compliance, depending on firm.
Rendering FDA license and NON FDA license
system in place for home rendering & feed 76% in compliance 79% cross
contamination 21% DID NOT have system 92% record keeping less than 60% total
compliance
279 inspectors 185 handling prohibited materials
Renderer at top of pyramid, significant part of compliance. 84% compliance
failed to have caution statement render 72% compliance & cross
contamination caution statement on feed, 'DO NOT FEED TO CATTLE'
56 FIRMS NEVER INSPECTED
1240 FDA license feed mills 846 inspected
"close to 400 feed mills have not been inspected"
80% compliance for feed.
10% don't have system.
NON-FDA licensed mills There is NO inventory on non licensed mills.
approximately 6000 to 8000 Firms ??? 4,344 ever inspected. "FDA does not have a
lot of experience with"
40% do NOT have caution statement 'DO NOT FEED'.
74% Commingling compliance
"This industry needs a lot of work and only half gotten to"
"700 Firms that were falitive, and need to be re-inspected, in addition to
the 8,000 Firms."
Quote to do BSE inspection in 19 states by end of January or 30 days, and
other states 60 days. to change feed status??? Contract check and ask questions
and pass info.
At this time, we will take questions.
[I was about the third or fourth to ask question. then all B.S.eee broke
loose, and i lost my train of thought for a few minutes. picked back up here]
someone asking about nutritional supplements and sourcing, did not get
name. something about inspectors not knowing of BSE risk??? the conference
person assuring that Steve Follum? and the TSE advisory Committee were handling
that.
Some other Dr. Vet, whom were asking questions that did not know what to
do???
[Dennis Wilson] California Food Agr. Imports, are they looking at imports?
[Conference person] they are looking at imports, FDA issued imports
Bulletin.
[Linda Singeltary ??? this was a another phone in question, not related i
don't think] Why do we have non-licensed facilities?
(conference person) other feed mills do not handle as potent drugs???
Dennis Blank, Ken Jackson licensed 400 non FDA 4400 inspected of a total of
6000 to 8000,
(they really don't know how many non licensed Firms in U.S. they guess 6000
to 8000??? TSS)
Linda Detwiler asking everyone (me) not to use emergency BSE number, unless
last resort. (i thought of calling them today, and reporting the whole damn U.S.
cattle herd ;-) 'not'
Warren-Maryland Dept. Agr. Prudent to re-inspect after 3 years. concerned
of Firms that have changed owners.
THE END
TSS
############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html
############
FROM New York TIMES
Subject: Re: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA
Posting of cut version... Date: Thu, 11 Jan 2001 22:02:47 -0700 From: "Sandy
Blakeslee" To: "Terry S. Singeltary Sr."
References: 1
Hi terry -- thanks for all your help. I know it made a difference with the
FDA getting out that release.
----- Original Message -----
Sent: Thursday, January 11, 2001 2:06 PM
Subject: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA Posting
of cut version...
snip...
> > hi sandy,
>From the New York Times NYTimes.com, January 11, 2001
Many Makers of Feed Fail to Heed Rules on Mad Cow Disease By SANDRA
BLAKESLEE
Large numbers of companies involved in manufacturing animal feed are not
complying with regulations meant to prevent the emergence and spread of mad cow
disease in the United States, the Food and Drug Administration said yesterday.
The widespread failure of companies to follow the regulations, adopted in
August 1997, does not mean that the American food supply is unsafe, Dr. Stephen
Sundlof, director of the Center for Veterinary Medicine at the F.D.A., said in
an interview.
But much more needs to be done to ensure that mad cow disease does not
arise in this country, Dr. Sundlof said.
The regulations state that feed manufacturers and companies that render
slaughtered animals into useful products generally may not feed mammals to
cud-chewing animals, or ruminants, which can carry mad cow disease.
All products that contain rendered cattle or sheep must have a label that
says, "Do not feed to ruminants," Dr. Sundlof said. Manufacturers must also have
a system to prevent ruminant products from being commingled with other rendered
material like that from chicken, fish or pork. Finally, all companies must keep
records of where their products originated and where they were sold.
Under the regulations, F.D.A. district offices and state veterinary offices
were required to inspect all rendering plants and feed mills to make sure
companies complied. But results issued yesterday demonstrate that more than
three years later, different segments of the feed industry show varying levels
of compliance.
Among 180 large companies that render cattle and another ruminant, sheep,
nearly a quarter were not properly labeling their products and did not have a
system to prevent commingling, the F.D.A. said. And among 347 F.D.A.-licensed
feed mills that handle ruminant materials - these tend to be large operators
that mix drugs into their products - 20 percent were not using labels with the
required caution statement, and 25 percent did not have a system to prevent
commingling.
Then there are some 6,000 to 8,000 feed mills so small they do not require
F.D.A. licenses. They are nonetheless subject to the regulations, and of 1,593
small feed producers that handle ruminant material and have been inspected, 40
percent were not using approved labels and 25 percent had no system in place to
prevent commingling.
On the other hand, fewer than 10 percent of companies, big and small, were
failing to comply with the record-keeping regulations.
The American Feed Industry Association in Arlington, Va., did not return
phone calls seeking comment.
Subject: USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE CALL Jan.
9, 2001
Date: Wed, 10 Jan 2001 14:04:21 –0500
######### Bovine Spongiform Encephalopathy
#########
USDA/APHIS would like to provide clarification on the following point from
Mr. Singeltary's 9 Jan posting regarding the 50 state conference call.
[Linda Detwiler asking everyone (me) not to use emergency BSE number,
unless last resort. (i thought of calling them today, and reporting the whole
damn U.S. cattle herd ;-) 'not']
Dr. Detwiler was responding to an announcement made during the call to use
the FDA emergency number if anyone wanted to report a cow with signs suspect for
BSE. Mr. Singeltary is correct that Dr. Detwiler asked participants to use the
FDA emergency number as a last resort to report cattle suspect for BSE. What Mr.
Singeltary failed to do was provide the List with Dr. Detwiler's entire
statement. Surveillance for BSE in the United States is a cooperative effort
between states, producers, private veterinarians, veterinary hospitals and the
USDA. The system has been in place for over 10 years. Each state has a system in
place wherein cases are reported to either the State Veterinarian, the federal
Veterinarian in Charge or through the veterinary diagnostic laboratory system.
The states also have provisions with emergency numbers. Dr. Detwiler asked
participants to use the systems currently in place to avoid the possibility of a
BSE-suspect report falling through the cracks. Use of the FDA emergency number
has not been established as a means to report diseased cattle of any nature.
Subject: Re: USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE CALL
Jan.9, 2001
Date: Wed, 10 Jan 2001 13:44:49 –0800
To: BSE-L@uni-karlsruhe.de References: 1
######### Bovine Spongiform Encephalopathy
#########
Hello Mr. Thomas,
> What Mr. Singeltary failed to do was provide > the List with Dr.
Detwiler's entire statement.
would you and the USDA/APHIS be so kind as to supply this list with a full
text version of the conference call and or post on your web-site? if so when,
and thank you. if not, why not?
> The system has been in place for over 10 years.
that seems to be a very long time for a system to be in place, and only
test 10,700 cattle from some 1.5 BILLION head (including calf crop). Especially
since French are testing some 20,000 weekly and the E.U. as a whole, are testing
many many more than the U.S., with less cattle, same risk of BSE/TSEs.
Why does the U.S. insist on not doing massive testing with the tests which
the E.U. are using? Why is this, please explain?
Please tell me why my question was not answered?
> U.S. cattle, what kind of guarantee can you > give for serum or
tissue donor herds?
It was a very simple question, a very important question, one that
pertained to the topic of BSE/feed, and asked in a very diplomatic way. why was
it not answered?
If all these years, we have been hearing that pharmaceutical grade bovines
were raised for pharmaceuticals vaccines etc. But yet the USA cannot comply with
feed regulations of the ruminant feed ban, PLUS cannot even comply with the
proper labelling of the feed, cross contamination etc. Then how in the world can
you Guarantee the feed fed to pharmaceutical grade bovine, were actually non
ruminant feed?
Before i was ask to be 'disconnected', i did hear someone in the background
say 'we can't'-- have him ask the question again.
could you please be so kind, as to answer these questions?
thank you, Terry S. Singeltary Sr. Bacliff, Texas USA
P.S. if you will also notice, i did not post that emergency phone number
and do not intend on passing it on to anyone. I was joking when i said i should
call and report the whole damn U.S. Herd. So please pass that on to Dr.
Detwiler, so she can rest easily.
BUT, they should be reported, some are infected with TSE. The U.S. is just
acting as stupid as Germany and other Countries that insist they are free of
BSE.
TSS
Subject: Report on the assessment of the Georgraphical BSE-risk of the USA
July 2000 (not good)
Date: Wed, 17 Jan 2001 21:23:51 –0800
######### Bovine Spongiform Encephalopathy
#########
Greetings List Members and ALL EU Countries,
Because of this report, and the recent findings of the 50-state BSE
Conference call, I respectfully seriously suggest that these Countries and the
SSC re-evaluate the U.S.A. G.B.R. to a risk factor of #3.
I attempted to post this to list in full text, but would not accept...
thank you, kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA
Report on the assessment of the Geographical BSE-risk of the USA July 2000
PART II
REPORT ON THE ASSESSMENT OF THE GEOGRAPHICAL BSE RISK OF THE UNITED STATES
OF AMERICA
- 29 -
Report on the assessment of the Geographical BSE-risk of the USA July 2000
EXECUTIVE SUMMARY
OVERALL ASSESSMENT
The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely
but cannot be excluded that domestic cattle are (clinically or pre-clinically)
infected with the BSE-agent.
Stability: Before 1990 the system was extremely unstable because feeding of
MBM to cattle happened, rendering was inappropriate with regard to deactivation
of the BSE-agent and SRM and fallen stock were rendered for feed. From 1990 to
1997 it improved to very unstable, thanks to efforts undertaken to trace
imported animals and exclude them from the feed chain and intensive
surveillance. In 1998 the system became neutrally stable after the RMBM-ban of
1997.
External challenges: A moderate external challenge occurred in the period
before 1990 because of importation of live animals from BSE-affected countries,
in particular from the UK and Ireland. It cannot be excluded that some
BSE-infected animals have been imported by this route and did enter the US
rendering and feed production system. The efforts undertaken since 1990 to trace
back UK-imported cattle and to exclude them from the feed chain reduced the
impact of the external challenge significantly.
Interaction of external challenges and stability: While extremely unstable,
the US system was exposed to a moderate external challenge, mainly resulting
from cattle imports from the UK. It can not be excluded that BSE-infectivity
entered the country by this route and has been recycled to domestic cattle. The
resulting domestic cases would have been processed while the system was still
very unstable or unstable and would hence have initiated a number of second or
third generation cases. However, the level of the possible domestic prevalence
must be below the low detection level of the surveillance in place.
As long as there are no changes in stability or challenge the probability
of cattle to be (pre-clinically or clinically) infected with the BSE-agent will
remain at the current level.
JUSTIFICATION
1. DATA
The available information was suitable to carry out the GBR risk
assessment.
- 30 -
Report on the assessment of the Geographical BSE-risk of the USA July 2000
2. STABILITY
2.1 Overall appreciation of the ability to identify BSE-cases and to
eliminate animals at risk of being infected before they are processed
· Before 1989, the ability of the system to identify (and eliminate) BSE
cases was limited. · Since 1990 this ability is significantly improved, thanks
to a good BSE-surveillance and culling system (contingency plan). · Today the
surveillance should be able to detect clinical BSE-cases within the limits set
by an essential passive surveillance system, i.e. some cases might remain
undetected.
2.2 Overall appreciation of the ability to avoid recycling BSE-infectivity,
should it enter processing
· Before 1997 the US rendering and feed producing system would not have
been able to avoid recycling of the BSE agent to any measurable extent. If the
BSE-agent was introduced the feed chain, it could probably have reached cattle.
· After the introduction of the RMBM-to-ruminants-ban in August 1997 the ability
of the system to avoid recycling of BSE-infectivity was somewhat increased. It
is still rather low due to the rendering system of ruminant material (including
SRM and fallen stock) and the persisting potential for cross-contamination of
cattle feed with other feeds and hence RMBM.
2.3 Overall assessment of the Stability
· Until 1990 the US BSE/cattle system was extremely unstable as RMBM was
commonly fed to cattle, the rendering system was not able to reduce
BSE-infectivity and SRM were rendered. This means that incoming BSE infectivity
would have been most probably recycled to cattle and amplified and the disease
propagated. · Between 1990 and 1995 improvements in the BSE surveillance and the
efforts to trace back and remove imported cattle gradually improved the
stability but the system remained very unstable. In 1998 the system became
unstable because of an RMBM-ban introduced in 1997. After 1998 the ban was fully
implemented and the system is regarded to be neutrally stable since 1998. The US
system is therefore seen to neither be able to amplify nor to reduce circulating
or incoming BSE-infectivity.
3. CHALLENGES
A moderate external challenge occurred in the period 1980-1989 because of
importation of live animals from the UK. imports from other countries are
regarded to have been negligible challenges. · As a consequence of this external
challenge, infectivity could have entered the feed cycle and domestic animals
could have been exposed to the agent. These domestic BSE-incubating animals
might have again entered processing, leading to an internal challenge since
1991. · This internal challenge could have produced domestic cases of BSE, yet
prevalence levels could have been below the detection limits of the surveillance
system until now. (According to US calculations, the current surveillance
-31 -
Report on the assessment of the Geographical BSE-risk of the USA July 2000
system could detect clinical incidence of 1-3 cases per year per million
adult cattle, i.e. in absolute numbers 43-129 cases per year). Between 1990 und
1995, with the exclusion of the imported animals from Europe from the feed
chain, the effect of the external challenges decreased.
4. CONCLUSION ON THE RESULTING RISKS
4.1 Interaction of stability and challenqe
· In the late 80s, early 90s a moderate external challenges met an
extremely unstable system. This would have amplified the incoming
BSE-infectivity and propagated the disease. · With the exclusion of the imported
animals from Europe from the feed chain between 1990 and 1995 the effect of the
external challenge decreased. · Before 1998 an internal challenge, if it
developed, would have met a still unstable system (inappropriate rendering, no
SRM ban, RMBM ban only after 1997) and the BSE-infectivity could have been
recycled and amplified. · After 1998 the neutrally stable system could still
recycle the BSE-agent but due to the RMBM-ban of 1997 the BSE-infectivity
circulating in the system would probably not be amplified.
4.2 Risk that BSE-infectivity enters processing
· A very low processing risk developed in the late 80s when the UK-imports
were slaughtered or died. It increased until 1990 because of the higher risk to
be infected with BSE of cattle imported from the UK in 1988/89, as these animals
could have been processed prior to the back-tracing of the UK-imports in 1990. ·
From 1990 to 1995 a combination of surviving non-traced UK imports and some
domestic (pre-)clinical cases could have arrived at processing resulting in an
assumed constant low but non-negligible processing risk. · After 1995 any
processing risk relates to assumed domestic cases arriving at processing. · The
fact that no domestic cases have been shown-up in the BSE-surveillance is
reassuring - it indicates that BSE is in fact not present in the country at
levels above the detection limits of the country's surveillance system. This
detection level has been calculated according to US-experts to be between 1
& 3 clinical cases per million adult cattle per year.
Note: The high turnover in parts of the dairy cattle population with a
young age at slaughter makes it unlikely that fully developed clinical cases
would occur (and could be detected) or enter processing. However, the
theoretical infective load of the pre-clinical BSE-cases that under this
scenario could be processed, can be assumed to remain relatively low.
4.3 Risk that BSE-infectivity is recycled and propagated
· During the period covered by this assessment (1980-1999) the US-system
was not able to prevent propagation of BSE should it have entered, even if this
ability was significantly improved with the MBM-ban of 1997. · However, since
the likelihood that BSE-infectivity entered the system is regarded to be small
but non-negligible, the risk that propagation of the disease took place is also
small but not negligible.
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Report on the assessment of the Geographical BSE-risk of the USA July 2000
5. CONCLUSION ON THE GEOGRAPHICAL BSE-RISK
5.1 The current GBR
The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely
but cannot be excluded that domestic cattle are (clinically or pre-clinically)
infected with the BSE-agent.
5.2 The expected development of the GBR
As long as there are no changes in stability or challenge the probability
of cattle to be (pre-clinically or clinically) infected with the BSE-agent
remains at the current level.
5.3 Recommendations for influencin.q the future GBR
· As long as the stability of the US system is not significantly enbanced
above neutral levels it remains critically important to avoid any new external
challenges. · All measures that would improve the stability of the system, in
particular with regard to its ability to avoid recycling of the BSE-agent should
it be present in the cattle population, would reduce, over time, the probability
that cattle could be infected with the BSE-agent. Possible actions include:
removal of SRMs and/or fallen stock from rendering, better rendering processes,
improved compliance with the MBM-ban including control and reduction of
cross-contamination. · Results from an improved intensive surveillance
programme, targeting at risk sub-populations such as adult cattle in fallen
stock or in emergency slaughter, could verify the current assessment.
snip...
Saturday, August 4, 2012
Final Feed Investigation Summary - California BSE Case - July 2012
SUMMARY REPORT CALIFORNIA BOVINE SPONGIFORM ENCEPHALOPATHY CASE INVESTIGATION JULY 2012
Summary Report BSE 2012 Executive Summary
Saturday, August 4, 2012
Update from APHIS Regarding Release of the Final Report on the BSE Epidemiological Investigation
TSS
posted by Terry S. Singeltary Sr. | 10:32 AM
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