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From: TSS ()
Subject: Re: cattletoday.com CENSORS TSS ON BSE AKA MAD COW
Date: March 21, 2006 at 10:30 am PST

In Reply to: Re: cattletoday.com CENSORS TSS ON BSE AKA MAD COW posted by TSS on March 21, 2006 at 10:28 am:


----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Sunday, March 19, 2006 11:34 AM
Subject: BSE OR MAD COW DISEASE : Current and Proposed Safeguards Updated
October 13, 2005


##################### Bovine Spongiform Encephalopathy
#####################


Bovine Spongiform Encephalopathy (BSE, or

“Mad Cow Disease”): Current and Proposed

Safeguards

Updated October 13, 2005

Geoffrey S. Becker

Specialist in Agricultural Policy

Resources, Science and Industry Division

Sarah A. Lister

Specialist in Public Health and Epidemiology

Domestic Social Policy Division


SNIP...

In August 2003, the United States had announced that it, Canada, and Mexico

were entering into discussions at the OIE to develop new guidance for
resuming trade

with countries that have reported BSE, under certain conditions. The basis
for the

proposal, according to U.S. officials, was that conditions for trade should
be based

not simply on the number of “mad cow” cases a country has reported. Rather,
trade

conditions should better reflect the adequacy of a country’s safeguards in
addressing

whatever level of risk is found through a scientifically valid risk
assessment. In other

words, countries with strong safeguards should not be penalized because
rigorous

testing has found an acceptably low number of BSE cases, whereas another
exporting

with inadequate protections may simply not be testing for and/or reporting
the

disease. On May 26, 2005, the OIE agreed to new BSE trade guidelines.
Included

is a simplified hierarchy of risk:

! Category 1 countries are those with negligible risk, and thus subject

to the least restrictive conditions for exporting ruminants and

ruminant products;

! Category 2 are those countries with controlled risk; and

! Category 3 are those where the risks are unknown.

In another guideline change, OIE decided that trade in boneless muscle beef

from cattle under 30 months of age should be considered to be safe,
regardless of

their exporting country’s BSE risk profile, so long as that country has
appropriate

controls in place. For example, one control would be an acceptable method
for

determining these animals’ ages and for segregating them from older animals.

The United States and Canada most likely fall within category 2, several

analysts have observed. Again, as under the prior OIE guidelines for BSE,
the newly

modified guidelines leave it up to the exporting countries to convince
importing

country authorities that their beef and cattle are safe. The importing
country, in turn,

might or might not accept these demonstrations of safety — and might not

necessarily agree to observe the OIE guidelines.


12 OIE authorities have explained that importing countries should evaluate
the source

country’s risk mitigation measures as a whole, not as separate items on a
checklist. See for

example, Declaration of David Wilson, head of the OIE International Trade
Department,

February 17, 2005, in the case Ranchers Cattlemen Action Legal Fund USA vs.
USDA (CV-

05-06-BLG-RFC).


CRS-10

13 U.S. Dept. of Agriculture, “Exportation and importation of animals and
animal products:

Bovine spongiform encephalopathy; minimal risk regions and importation of
commodities,”

68 Federal Register 62386, Nov. 4, 2003.

If a bilateral trade disagreement over a country’s BSE safeguards were to
reach

an international dispute panel, presumably that panel would look to the OIE

guidelines for direction in resolving it. However, a dispute resolution
process (such

as under the Uruguay Round agreements administered by the World Trade

Organization) can be lengthy and not always settled to the satisfaction of
either party.

The U.S.-supported approach to BSE and trade has been put to the test
recently

by practical developments between the United States and its trading
partners. More

specifically, Canada has been seeking expansion of its permitted ruminant
exports

to the United States. Although the Administration and many in Congress agree
with

Canada, several U.S. producer groups and their allies do not (see “Canadian
Beef and

Cattle Imports,” below). At the same time, the United States has been trying
to

regain access to the Japanese, Korean, and other important export markets,
which

have been closed since the United States found its first case of BSE in
December

2003. This is despite U.S. efforts to convince them that U.S. safeguards are

scientifically sound, and that they equal or exceed the
internationally-recognized

standards (see “Japan Beef Trade Issues” later in this section).


snip...


CRS-25

49 See FDA, “BSE — CVM Updates” page at
[http://www.fda.gov/cvm/bse_updates.htm].

50 See, for example, FDA, “FDA Statement on Rendered Products Derived From
BSE Cow

in Washington State,” Dec. 27, 2003, at [http://www.fda.gov/bbs/topics/NEWS/

2003/NEW01000.html].

51 Such tests would determine only if prohibited materials were present in
the feed, not

whether infectious BSE prions were present. No such prion test for feed
exists.

52 GAO, FDA’s Management of the Feed Ban Has Been Improved, but Oversight

Weaknesses Continue to Limit Program Effectiveness (GAO-05-101), Feb. 2005.
See also

GAO, Mad Cow Disease: Improvements in the Animal Feed Ban and Other
Regulatory

Areas Would Strengthen U.S. Prevention Efforts, (GAO-02-183), Jan. 2002.

Enforcement of the Feed Ban

The FDA Center for Veterinary Medicine has since 2001 provided periodic

updates of its feed ban enforcement activity on a public website.49 On June
20, 2005,

the agency reported that it had identified and conducted initial inspections
on 15,676

renderers, feed mills, protein blenders and related establishments. The
agency noted

that 4,093 of them (26%) handled materials prohibited for use in ruminant
feeds. Of

this subset, FDA reported that the vast majority were within compliance.

FDA has asserted on several occasions that feed industry compliance with the

ban has reached 99%.50 FDA bases its compliance determinations on inspection
of

facilities, practices, and records. At this time there is no certified test
that can be

used on actual ruminant feed to determine if it contains prohibited
material. In its

July 2004 ANPR, FDA requested information on potential test methods for
detecting

SRM in animal feed.51

The Government Accountability Office (GAO) has twice evaluated FDA’s

oversight of the feed ban, in 2002 and 2005, and reported a number of
problems with

administrative procedures, inspection, and enforcement.52 In its February
2005

report, GAO commented that FDA’s 99% reported compliance rate may be

misleading because the rate was based on inspections of only about 570
firms. GAO

added that FDA does not include all serious violations in its calculations
because it

reclassifies firms as being in compliance once they correct violations, no
matter how

long a problem existed. For this and other reasons GAO said that FDA did not
have

sufficient information to calculate a compliance rate and recommended
instead that

the agency report enforcement information in its complete context.

Also in its 2005 report, GAO concluded that FDA had made improvements in

its management of the feed ban since the 2002 GAO report, but that “various

program weaknesses continue to undermine the nation’s firewall against BSE.”
One

of the weaknesses cited was the lack of a uniform approach to identify all
the

additional feed manufacturers, on-farm mixers, and other feed industry
businesses

beyond the approximately 14,800 firms the agency had identified. Among other

concerns, GAO also commented that FDA had not reinspected approximately
2,800

firms for several years and therefore does not know whether they use
prohibited

materials in their feed, that the agency had not required a warning label on
feed for

export that is not intended for cattle and other ruminants, and that it had
not always


alerted USDA and the states when it learns that cattle may have been given

prohibited feed.

The preamble to the October 6, 2005, proposed feed rule provides additional

insights into compliance with the present ban. FDA stated that during FY2004
and

the first half of FY2005, federal and state inspections had identified 41
instances of

cross-contamination or commingling problems in firms that handle feeds
containing

prohibited mammalian protein. That number represented 0.4% of inspections.

During the same period these inspectors found 165 instances of mislabeling
(1.7%)

and 604 instances of improper recordkeeping (6.3%).


snip...


Surveillance Program Criticisms. USDA’s surveillance program has

garnered considerable criticism. On February 17, 2004, the House Committee
on

Government Reform held a hearing to question USDA officials and others,
following

the Committee’s month-long investigation into the circumstances surrounding
testing

of the Washington state cow (December 2003). The Committee Chairman and

Ranking Member released a letter to the Secretary of Agriculture the same
day, in

which they questioned whether the cow was in fact non-ambulatory when it was

selected for testing.65 The committee raised questions relevant to the
design of an

improved surveillance program. If in fact the animal were not a downer but
rather

an apparently healthy cow with BSE, had the surveillance program been
targeted

effectively, and could Congress be confident that the disease is very rare
in the

United States?

On April 27, 2004, a cow showing signs of a central nervous system disease
at

a Texas slaughter plant was condemned for human food use by FSIS, and the
FSIS

veterinarian on site recommended that it be tested for BSE. However, a
higher-level

APHIS official determined that it should not be tested, so the animal’s
carcass was

sent to a rendering plant for processing into inedible byproducts. This led
some

critics to charge that the Department had “covered up” a possible case of
BSE.

Such testing concerns became subjects of investigations by USDA’s Inspector

General (IG). She presented her preliminary findings at a joint hearing held
July 14,

2004, by the House Government Reform and Agriculture Committees. The IG told

the committees that in the case of the Washington state cow, her office had
“...found

no instances where USDA personnel knowingly conveyed false or misleading

information, or engaged in intentional misconduct.” The investigation,
however,

“...did reveal procedural errors and inconsistent descriptions that gave
rise to some

of the public concerns that the identification of the BSE-positive cow may
have been

mishandled.”66


65 Letter from Reps. Tom Davis and Henry Waxman to Agriculture Secretary
Veneman

concerning “Mad Cow” Disease, Feb. 17, 2004, and related documents,
available at

[http://reform.house.gov/GovReform/News/DocumentSingle.aspx?DocumentID=2497]
.

66 Testimony of Phyllis K. Fong, USDA Inspector General, “A Review of the
USDA”s

Expanded BSE Cattle Surveillance Program,” joint hearing of the House
Committee on

Government Reform and the House Committee on Agriculture, July 14, 2004.


CRS-32

67 Ibid.

68 USDA, Office of Inspector General Audit Report, Animal and Plant Health
Inspection

Service and Food Safety and Inspection Service Bovine (BSE) Surveillance
Program —

Phase I, Report No. 50601-9-KC, August 2004.

The IG testified that her office also found “no substantive evidence” that
USDA

officials provided any “false information or engaged in intentional
misconduct” in

the Texas case. However, the IG cited inconsistencies in officials’
understanding of

BSE sampling and carcass handling procedures. As a result, FSIS and APHIS on

May 5, 2004, had announced a new joint policy to clarify these procedures
and

responsibilities, she observed.67

The IG also presented the preliminary results of an audit of the Department’
s

expanded surveillance plan, finding a number of inconsistences. For example,
the

IG stated that surveillance findings may be unreliable because the plan: is
not truly

random since participation is voluntary; assumes that BSE is confined only
to the

high-risk cattle population while other studies show that healthy-looking
animals

could have BSE; does not include a process for obtaining animals that die on
farms;

cannot obtain a statistically appropriate geographical representation of the
cattle

population; and does not allow APHIS to find and test enough cattle in the
high-risk

population. The final OIG report, issued in late August 2004, generally
paralleled the

preliminary findings.68

The Secretary of Agriculture and other USDA officials at the July 2004
hearing

defended the surveillance program, noting among other things that the OIG

observations were based on the plan before it was implemented and that many
of the

report’s recommendations had already been addressed. APHIS was receiving a

representative mix of samples from all locations, reaching deeply into the
higher-risk

cattle population, and the statistical basis for the sampling was sound,
officials

asserted. They added that adjustments had been made as the result of ongoing

assessments of the program. The OIG has continued to assess the testing
program.

It was at the IG’s insistence that APHIS researchers re-tested tissue from a
cow that

first was determined to be negative, and then ultimately positive for BSE
(see below).

“Inconclusive” Test Results. In June 2004, shortly after the enhanced

surveillance program was begun, USDA announced two inconclusive findings for

BSE which were later determined to be negative. The finding announced on
June 25,

2004, was confirmed negative on June 30. The finding announced on June 29,
2004,

was confirmed negative on July 2. USDA reported each inconclusive finding
but did

not provide information on the location or any other details about the
animals.

According to policy instituted in December 2003, the carcasses of the two
affected

animals were held pending test results, and were later destroyed.

Cattle market prices fell in response to news of the inconclusive findings,
but

rebounded to varying degrees once the conclusive negative results were
announced.

USDA was criticized both for releasing too much and too little information,
though

some industry groups said the policy to release partial information struck
the right

balance. During the wait for final results, USDA officials repeated the
assertion that

rumors generated by withholding information while an inconclusive test were


67 Ibid.

68 USDA, Office of Inspector General Audit Report, Animal and Plant Health
Inspection

Service and Food Safety and Inspection Service Bovine (BSE) Surveillance
Program —

Phase I, Report No. 50601-9-KC, August 2004.

CRS-33

69 See for example “New mad cow case possible,” The Kansas City Star; and
“Mad cow test

news again hits producers; As future prices fall, officials industry promote
safety of U.S.

beef,” The Fort Worth Star Telegram, both November 19, 2004.

70 Statement by Clifford, John, APHIS Deputy Administrator, November 23,
2004.

71 “Market Rebounds With a Vengeance,” Cattle Buyers Weekly, November 29,
2004.

pending would be just as damaging to markets as would the release of
preliminary

findings. They also reiterated that given the extent of the enhanced
surveillance

problem, some false positive screening tests were to be expected and,
possibly,

additional true cases of BSE could surface as well.

APHIS’s policy had been to announce an inconclusive result if an initial

screening test were positive. APHIS changed this policy after the
controversy and

market uncertainties which followed the first two inconclusive
announcements. On

August 4, 2004, the agency stated that it would announce a result as
inconclusive

(i.e., testing positive in the screen but not yet confirmed in follow-up
testing) only if

a second screening test on the sample were also positive.

Confirmatory Testing Methods. With this newer policy in place, APHIS

announced another inconclusive finding on November 18, 2004. As with the

previous two announcements, the agency did not provide details on the animal
’s age

or location, although some unconfirmed press reports speculated that it was
a 12-

year-old cow in Texas. Cattle market prices again fell steeply, as did stock
prices for

such chains as McDonald’s Corporation and Wendy’s International.69

Five days later, on November 23, APHIS reported that confirmatory testing at

its Ames NVSL facility had found the sample to be negative for BSE. Ames had
run

the

immunohistochemistry (IHC) test, an internationally-recognized gold standard

test.... Because the November 18 screening test results were reactive in
both the

first and second screens, NVSL scientists made the recommendation to run the

IHC test a second time.... Negative results make us confident that the
animal in

question is indeed negative for BSE.70

Following this announcement, live cattle prices rebounded dramatically,
enabling

cattle producers to more than recoup their earlier losses at the expense of
buyers (i.e.,

meat packers) who paid the higher prices, thus incurring their own operating
losses.71

When its November 2004 IHC test came back negative for BSE, USDA did not

run the other OIE-recognized confirmatory test, the Western blot, or send
tissue to

the World Reference Laboratory in Weybridge, England, to evaluate the
sample. By

contrast, USDA did run the Western blot test and consult with Weybridge to
confirm

the BSE-positive result in December 2003.

In the spring of 2005, USDA’s IG asked APHIS to retest the samples from the

three 2004 “inconclusives,” because of its concerns about the original
testing. For

example, the November 2004 sample should not have been frozen; and there
were

paperwork reporting problems, it was reported. This OIG-requested retesting
in early


69 See for example “New mad cow case possible,” The Kansas City Star; and
“Mad cow test

news again hits producers; As future prices fall, officials industry promote
safety of U.S.

beef,” The Fort Worth Star Telegram, both November 19, 2004.

70 Statement by Clifford, John, APHIS Deputy Administrator, November 23,
2004.

71 “Market Rebounds With a Vengeance,” Cattle Buyers Weekly, November 29,
2004.


CRS-34

72 Transcript of media conference, June 24, 2005, at
[http://www.usda.gov/wps/

portal/usdahome]. For an explanation of the two OIE-approved tests, see the
June 2005

APHIS factsheet at [http://www.aphis.usda.gov/lpa/pubs/fsheet_faq_notice/

faq_BSE_confirmtests.pdf].

73 Ibid.

74 Transcript of media conference, June 24, 2005. The APHIS website also has
posted a

series of factsheets explaining in more detail the confirmatory testing
methods and how they

were applied in this case.

June 2005 was done by USDA scientists (reportedly without the direct
knowledge

of the Secretary of Agriculture) using the Western blot method. When this
test

showed the presence of BSE in the November 2004 sample, the Secretary of

Agriculture made the result public on June 10, calling it a “weak positive.”
USDA

officials delivered a sample from the animal to Weybridge for further
testing and also

began their own additional testing.

The Weybridge lab conducted a series of analyses on the sample. All but one

detected BSE, including another IHC test. The Secretary of Agriculture
explained

that the positive IHC test by Weybridge used a different procedure than the
one used

in November 2004 by USDA at Ames. A Weybridge scientist, Dr. Danny Matthews,

confirmed that “there are no two laboratories around the world that are
using

identical IHC methods and not a single test that you can take off the
shelf,” so that

tests may not perform comparably.72

USDA officials also revealed on June 24, 2005, that a USDA laboratory had

actually found possible BSE in the animal when it applied an “experimental”
version

of the IHC test back in November 2004. However, they asserted that the
laboratory

had not reported this result because the test method had not been validated
for

regulatory use.73 This information, and the positive BSE confirmation by
Weybridge,

provoked strong criticism by consumer groups and several Members of
Congress.

They expressed renewed skepticism about the adequacy of USDA’s testing
methods

and procedures; about department officials’ efforts to communicate all
relevant

information about BSE in the United States; and about earlier assurances
that the

IHC was “the gold standard.”

Secretary Johanns, who replaced Ann Veneman as Secretary earlier in 2005,

promised on June 24, 2005, that henceforth the Department would conduct two
types

of confirmatory tests — the IHC and the Western blot — if any screening
tests were

to yield an “inconclusive” result. If either confirmatory test is positive,
a positive

result will be reported, he announced. But Secretary Johanns also defended
USDA’s

surveillance program, stating, “Science is ever evolving. It is not static.
And as we

learn more we apply the knowledge.” USDA is carefully reviewing its testing
to

ensure that it is “in line with the very latest science,” he said, adding,
“perhaps the

most important thing to remember is that we’ve only needed this test three
times

since our enhanced surveillance began.”74

In all three instances of “inconclusives,” the so-called Bio-Rad ELISA test
was

used as the screening test. Bio-Rad Laboratories has previously said that
its test

detected a case of BSE in a 23-month old bull in Japan, shown to be positive
on a


72 Transcript of media conference, June 24, 2005, at
[http://www.usda.gov/wps/

portal/usdahome]. For an explanation of the two OIE-approved tests, see the
June 2005

APHIS factsheet at [http://www.aphis.usda.gov/lpa/pubs/fsheet_faq_notice/

faq_BSE_confirmtests.pdf].

73 Ibid.

74 Transcript of media conference, June 24, 2005. The APHIS website also has
posted a

series of factsheets explaining in more detail the confirmatory testing
methods and how they

were applied in this case.


CRS-35

75 For more information, see OIE, Disease Information, “Bovine spongiform
encephalopathy

in Japan: atypical case,” Vol. 16, No. 41, Oct. 10 2003, at
[http://www.oie.int] and the Bio-

Rad Laboratories website, [http://www.bio-rad.com].

76 “Second US cow tests positive for BSE,” NewScientist.com News Service,
June 28, 2004.

77 USDA, “Statement by Bill Hawks, Undersecretary for Marketing and
Regulatory

Programs Regarding a Request by Creekstone for Private BSE Testing,” press
release, Apr.

9, 2004.

78 For information on these programs, see the website of USDA’s Agricultural
Marketing

Service at [http://www.ams.usda.gov/].

79 A legal analysis of the Creekstone decision is available in CRS Report
RL32414, The

Private Testing of Mad Cow Disease: Legal Issues, by Stephen R. Vina.

Western blot test, but negative on immunohistochemistry (IHC) — a case that
Japan

reported to OIE as “atypical BSE.”75 It also has been reported that the
Bio-Rad

screening test has been found to be “false positive” (i.e., positive in the
screening test

but negative upon confirmatory testing) at a rate of about one in a thousand
times.76

The variety of testing schemes for BSE and seemingly conflicting statements
about

their accuracy illustrates that laboratory science itself, and international
consensus

on it, continue to evolve.

Private BSE Testing: The Creekstone Decision


snip...

http://www.ncseonline.org/NLE/CRSreports/05oct/RL32199.pdf

BSE GBR ASSESSMENTS


http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/catindex_en.h
tml

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR)
of the United States of America (USA)
Last updated: 19 July 2005
Adopted July 2004 (Question N° EFSA-Q-2003-083)

Report
Summary
Summary of the Scientific Report

The European Food Safety Authority and its Scientific Expert Working Group
on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE)
Risk (GBR) were asked by the European Commission (EC) to provide an
up-to-date scientific report on the GBR in the United States of America,
i.e. the likelihood of the presence of one or more cattle being infected
with BSE, pre-clinically as well as clinically, in USA. This scientific
report addresses the GBR of USA as assessed in 2004 based on data covering
the period 1980-2003.

The BSE agent was probably imported into USA and could have reached domestic
cattle in the middle of the eighties. These cattle imported in the mid
eighties could have been rendered in the late eighties and therefore led to
an internal challenge in the early nineties. It is possible that imported
meat and bone meal (MBM) into the USA reached domestic cattle and leads to
an internal challenge in the early nineties.

A processing risk developed in the late 80s/early 90s when cattle imports
from BSE risk countries were slaughtered or died and were processed (partly)
into feed, together with some imports of MBM. This risk continued to exist,
and grew significantly in the mid 90’s when domestic cattle, infected by
imported MBM, reached processing. Given the low stability of the system, the
risk increased over the years with continued imports of cattle and MBM from
BSE risk countries.

EFSA concludes that the current GBR level of USA is III, i.e. it is likely
but not confirmed that domestic cattle are (clinically or pre-clinically)
infected with the BSE-agent. As long as there are no significant changes in
rendering or feeding, the stability remains extremely/very unstable. Thus,
the probability of cattle to be (pre-clinically or clinically) infected with
the BSE-agent persistently increases.


Publication date: 20 August 2004


http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573_it.html


http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573/sr03_bioh
az02_usa_report_summary_en1.pdf


http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573/sr03_bioh
az02_usa_report_v2_en1.pdf


suppressed peer review of Harvard study October 31, 2002

http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf

TSS

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