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From: TSS ()
Subject: BSE; Minimal-Risk Regions and Importation of Commodities; Finding of No Significant Impact and Affirmation of Final Rule; Final Rule
Date: April 8, 2005 at 1:53 pm PST

-------- Original Message --------
Subject: BSE; Minimal-Risk Regions and Importation of Commodities; Finding of No Significant Impact and Affirmation of Final Rule; Final Rule
Date: Fri, 8 Apr 2005 10:35:13 -0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@KALIV.UNI-KARLSRUHE.DE

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

[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 18251]]

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Part VII

Department of Agriculture

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Animal and Plant Health Inspection Service

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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]]

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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.

ACTION: Affirmation of final rule.

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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.

ADDRESSES: The environmental assessment on which this finding of no
significant impact is based may be accessed by any of the following
methods:
On the EDOCKET Web site at http://docket.epa.gov/ edkfed/

do/ EDKStaff CollectionDetailView?objectId = 0b0007d48055a20d.
On the APHIS Web site at http://www.aphis.usda.gov/lpa/issues/bse/bse.html
.

In the APHIS Reading Room 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.
You may request paper copies of the environmental
assessment and the finding of no significant impact by calling or
writing to the person listed under FOR FURTHER INFORMATION CONTACT.
Please refer to the titles of these documents when requesting copies.

FOR FURTHER INFORMATION 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.

SUPPLEMENTARY INFORMATION:

snip...

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

EFSA Scientific
Report on the Assessment of the Geographical BSE-Risk (GBR) of the United
States of America (USA)

Publication date: 20 August 2004

Adopted July 2004 (Question N° EFSA-Q-2003-083)

* 167 kB Report

* 105 kB 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 90s 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.

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573_en.html

USA BSE GBR RAISED TO BSE GBR III

Working Group Report on the Assessment of the Geographical BSE-Risk (GBR

III) of USA 2004 ''extremely/very unstable BSE/cattle system''

USA

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/574/sr03_biohaz02_usa_report_annex_en1.pdf>

CANADA

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/563/sr02_biohaz02_canada_report_annex_en1.pdf

MEXICO

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/566/sr04_biohaz02_mexico_report_annex_en1.pdf

Canada and the United States have been raised to level III (presence of BSE
likely but not confirmed, or confirmed at a lower level) following a new
assessment taking into account the most recent evidence. EFSAs Scientific
Expert Working Group on geographic BSE risk assessment also evaluated the
status of Mexico and South Africa which were classified as level III.

http://www.efsa.eu.int/press_room/press_release/575_en.html

From: Terry S. Singeltary Sr. [flounder@wt.net]

Sent: Tuesday, July 29, 2003 1:03 PM

To: fdadockets@oc.fda.gov

Cc: ggraber@cvm.fda.gov; Linda.Grassie@fda.gov;
BSE-L

Subject: Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION

TO DOCKET 2003N-0312]

Greetings FDA,

snip...

PLUS, if the USA continues to flagrantly ignore the _documented_ science
to date about the known TSEs in the USA (let alone the undocumented TSEs
in cattle), it is my opinion, every other Country that is dealing with BSE/TSE
should boycott the USA and demand that the SSC reclassify the USA BSE GBR
II risk assessment to BSE/TSE GBR III 'IMMEDIATELY'. for the SSC to _flounder_
any longer on this issue, should also be regarded with great suspicion as
well. NOT to leave out the OIE and it's terribly flawed system of disease
surveillance. the OIE should make a move on CWD in the USA, and make a risk
assessment on this as a threat to human health. the OIE should also change
the mathematical formula for testing of disease. this (in my opinion and
others) is terribly flawed as well. to think that a sample survey of 400
or so cattle in a population of 100 million, to think this will find anything,
especially after seeing how many TSE tests it took Italy and other Countries
to find 1 case of BSE (1 million rapid TSE test in less than 2 years, to
find 102 BSE cases), should be proof enough to make drastic changes of this
system. the OIE criteria for BSE Country classification and it's interpretation
is very problematic. a text that is suppose to give guidelines, but is not
understandable, cannot be considered satisfactory. the OIE told me 2 years
ago that they were concerned with CWD, but said any changes might take years.
well, two years have come and gone, and no change in relations with CWD
as a human health risk. if we wait for politics and science to finally make
this connection, we very well may die before any decisions

or changes are made. this is not acceptable. we must take the politics and
the industry out of any final decisions of the Scientific community. this
has been the problem from day one with this environmental man made death
sentence. some of you may think i am exaggerating, but you only have to
see it once, you only have to watch a loved one die from this one time,
and you will never forget, OR forgive...yes, i am still very angry... but
the transmission studies DO NOT lie, only the politicians and the industry
do... and they are still lying to this day...TSS

http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt

What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

www.gao.gov/cgi-bin/getrpt?GAO-05-101.

To view the full product, including the scope

and methodology, click on the link above.

For more information, contact Robert A.

Robinson at (202) 512-3841 or

robinsonr@gao.gov.

Highlights of GAO-05-101, a report to

congressional requesters

February 2005

MAD COW DISEASE

FDAs Management of the Feed Ban Has

Improved, but Oversight Weaknesses

Continue to Limit Program Effectiveness

FDA has made needed improvements to its management and oversight of the

feed-ban rule in response to GAOs 2002 report, but program weaknesses

continue to limit the effectiveness of the ban and place U.S. cattle at risk of

spreading BSE. Improvements made include FDA establishing a uniform

method of conducting compliance inspections and training FDA inspectors,

as well as state inspectors who carry out inspections under agreements with

FDA, on the new method. FDA also implemented new data-entry procedures

that are designed to more reliably track feed-ban inspection results.

Consequently, FDA has a better management tool for overseeing compliance

with the feed-ban rule and a data system that better conforms to standard

database management practices. However, various program weaknesses

continue to undermine the nations firewall against BSE. For example:

" FDA acknowledges that there are more feed manufacturers and

transporters, on-farm mixers, and other feed industry businesses that are

subject to the feed ban than the approximately 14,800 firms inspected to

date; however, it has no uniform approach for identifying additional

firms.

" FDA has not reinspected approximately 2,800, or about 19 percent, of

those businesses, in 5 or more years; several hundred are potentially

high risk. FDA does not know whether those businesses now use

prohibited material in their feed.

" FDAs feed-ban inspection guidance does not include instructions to

routinely sample cattle feed to test for potentially prohibited material as

part of the compliance inspection. Instead, it includes guidance for

inspectors to visually examine facilities and equipment and review

invoices and other documents.

" Feed intended for export is not required to carry a caution label Do not

feed to cattle or other ruminants, when the label would be required if

the feed were sold domestically. Without that statement, feed containing

prohibited material could be inadvertently or intentionally diverted back

to U.S. cattle or given to foreign cattle.

" FDA has not always alerted USDA and states when it learned that cattle

may have been given feed that contained prohibited material. This lapse

has been occurring even though FDAs guidance calls for such

communication.

" Although research suggests that cattle can get BSE from ingesting even a

small amount of infected material, inspectors do not routinely inspect or

review cleanout procedures for vehicles used to haul cattle feed.

More than 5 million cattle across

Europe have been killed to stop the

spread of bovine spongiform

encephalopathy (BSE), commonly

called mad cow disease. Found in

26 countries, including Canada and

the United States, BSE is believed

to spread through animal feed that

contains protein from BSE-infected

animals. Consuming meat from

infected cattle has also been linked

to the deaths of about 150 people

worldwide. In 1997, the Food and

Drug Administration (FDA) issued

a feed-ban rule prohibiting certain

animal protein (prohibited

material) in feed for cattle and

other ruminant animals. FDA and

38 states inspect firms in the feed

industry to enforce this critical

firewall against BSE. In 2002, GAO

reported a number of weaknesses

in FDAs enforcement of the feed

ban and recommended corrective

actions. This report looks at FDAs

efforts since 2002 to ensure

industry compliance with the feed

ban and protect U.S. cattle.

What GAO Recommends

GAO recommends FDA, among

other things, develop procedures

for finding additional firms subject

to the feed-ban and using tests to

augment inspections. FDA said the

study was thorough but disagreed

on four of nine recommendations.

GAO continues to believe that,

given the discovery of BSE in North

America and the oversight gaps

described in the report, the

recommended actions are needed

to protect U.S. cattle from BSE.

3. Mad Cow Disease: FDA's Management of the Feed Ban Has Improved,

but Oversight Weaknesses Continue to Limit Program Effectiveness.

GAO-05-101, Feb. 25.

http://www.gao.gov/cgi-bin/getrpt?GAO-05-101

Highlights - http://www.gao.gov/highlights/d05101high.pdf

Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION]

http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt

Docket Management Docket: 02N-0273 - Substances Prohibited From Use in

Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

Comment Number: EC -10

Accepted - Volume 2

http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html

PART 2

http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html

Terry S. Singeltary Sr. P.O. BOX 42 Bacliff, TEXAS USA

######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html ##########

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