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From: TSS ()
Subject: GW's BSE MRR MINIMAL RISK REGION the legal spreading of global TSEs, a recipe for disaster
Date: July 23, 2005 at 6:35 am PST

Questions and

Answers for Minimal-

Risk (Canada) Rule

Q. What does the final rule on bovine spongiform

encephalopathy (BSE) and minimal-risk regions

change?

A. The rule amends regulations regarding the importation

of ruminants and ruminant products and

byproducts. It establishes a set of conditions whereby

a country can be recognized as presenting minimal

risk of introducing BSE into the United States.

The new rule will continue to protect the United

States from the introduction of BSE, while removing

unnecessary prohibitions on the importation of certain

commodities from minimal-risk regions.

Q. What is a minimal-risk region?

A. A minimal-risk region must meet the standards

described in the rule and includes

• A region in which BSE-infected animals have

been diagnosed but sufficient regulatory measures

have been put in place that would make

the introduction of BSE into the United States

unlikely; or

• A region that has taken effective regulatory measures

to prevent BSE, has never detected the

disease, but cannot be considered BSE-free.

A minimal-risk region must have had in place,

prior to the detection of BSE, risk-mitigation measures

—such as import restrictions, a ruminant-toruminant

feed ban, and surveillance—adequate to

prevent widespread establishment of the disease.

The region also should conduct epidemiologic investigations

and risk assessments when cases are identified

and impose additional risk-mitigation measures

as necessary.

Q. Has any country met the conditions and been

listed as a minimal-risk region?

A. Canada has provided information for an evaluation

and has been determined to meet the conditions

of a minimal-risk region. The U.S. Department of

Agriculture (USDA) conducted a thorough, scientific

assessment to evaluate the risk of resuming the

importation of Canadian ruminants and ruminant

products in view of the two BSE cases of Canadian

origin. This risk assessment included careful consideration

of the risk-mitigation measures Canada

has in place, the risk-mitigation measures in the

United States, and also the risk-mitigation measures

imposed in this final rule. The assessment confirms

that allowing the importation of certain Canadian

ruminants and ruminant products under the conditions

imposed by the rule will continue to protect

against introduction of BSE into the United States.

Q. What types of mitigation measures does

Canada have in place to qualify as a minimal-risk

region?

A. The minimal-risk standards that Canada has met

include

• Import restrictions sufficient to minimize exposure

to BSE: Since 1990, Canada has maintained

stringent import restrictions, preventing

the entry of live ruminants and ruminant products,

including rendered protein products, from

countries that have found BSE in native cattle or

that are considered to be at significant risk for

BSE.

• Surveillance for BSE at levels that meet or

exceed international guidelines: Canada has

conducted active surveillance for BSE since

1992 and exceeded the level recommended in

international guidelines for at least the past 7

years.

• Ruminant-to-ruminant feed ban in place and

effectively enforced: Canada has had a ban on

the feeding of ruminant proteins to ruminants

since August 1997, with compliance monitored

through routine inspections.

• Appropriate epidemiologic investigations, risk

assessments, and risk-mitigation measures

imposed as necessary: Canada has conducted

extensive investigations in response to any BSE

finding and has taken additional mitigation measures

in response. These risk-mitigation measures

include, among others, prohibiting specified

risk materials in human food.

Q. Why is Canada in a different category from

other countries where BSE has been discovered?

A. USDA has determined through a scientific risk

assessment that the risk presented by opening the

borders to certain Canadian ruminants and ruminant

products is minimal. We have used international

recommendations—as defined by the World

Organisation for Animal Health (OIE)—as a reference

in developing these regulations. The OIE recom-

Factsheet

July 2005 Veterinary Services

APHIS

mendation, based on current scientific understanding,

recognizes that there are different levels of risk

in countries or regions, and provides guidelines for

trade according to these levels of risk. Canada has

had a stringent set of risk-mitigation measures in

place for several years prior to the diagnosis of a

case of BSE. Thus, the first case doesn’t represent

the front edge of a rapidly increasing outbreak situation.

It represents a limited exposure that occurred

years ago that has not continued to circulate or

amplify. This creates a very different risk scenario as

compared to a country that diagnoses the first case

of BSE and then begins to institute risk-management

measures. In this latter scenario, the disease would

have continued to amplify, and the first case may

have indicated the beginning of a significant outbreak

curve.

Other countries may seek minimal-risk status

if they meet the necessary conditions. USDA will

determine the eligibility of future countries in the

same manner it used with Canada-risk analysis and

appropriate rulemaking procedures.

Q. What types of products will be eligible for

importation from Canada?

A. The commodities that will be allowed to be imported

from Canada under specified conditions under

this final rule can be summarized as

• Bovines for feeding or immediate slaughter, as

long as they are slaughtered at less than 30

months;

• Sheep and goats (ovines and caprines) for feeding

or immediate slaughter, as long as they are

slaughtered at less than 12 months of age;

• Meat from bovines, ovines, caprines, and cervids

(deer, elk, caribou, moose, and reindeer); and

• Certain other products and byproducts, including

bovine livers and tongues, gelatin, and tallow.

USDA is also specifying that there are no import

restrictions due to BSE for live cervids or camelids

(i.e., llamas, alpacas, guanacos, and vicunas) from a

BSE minimal-risk region.

Q. When will cattle start crossing the border from

Canada?

A. The rule is effective immediately–July 15, 2005–

due to the order from the Circuit Court, and the live

animals and products addressed in the rule are eligible

for importation as of that date. However, to

ensure appropriate certification procedures and policies

are in place, USDA does not expect any movement

to occur until Monday, July 18, 2005.

Q. Under the new rule, can live ruminants from

Canada enter the United States through any port?

A. The final rule requires that live ruminants from

Canada enter the United States through specified

ports-of-entry. These 20 entry points have the

facilities available to ensure the requirements of

the final rule are being met: Eastport, ID; Houlton,

and Jackman, ME; Detroit, Port Huron, and Sault

Ste. Marie, MI; Baudette, MN; Opheim, Raymond,

and Sweetgrass, MT; Alexandria Bay, Buffalo, and

Champlain, NY; Dunseith, Pembina, and Portal, ND;

Derby Line and Highgate Springs, VT; Oroville and

Sumas, WA.

Q. Can ruminant products come through the same

entry ports as live ruminants?

A. No, all ruminant products entering the United

States from Canada must, if arriving at a land border

port, arrive at one of the following ports: Eastport,

ID; Calais and Houlton, ME; Detroit (Ambassador

Bridge), Port Huron, and Sault St. Marie, MI;

International Falls, MN; Raymond, Roosville, and

Sweetgrass, MT; Alexandria Bay, Buffalo (Lewiston

Bridge and Peace Bridge), and Champlain, NY;

Pembina and Portal, ND; Derby Line and Highgate

Springs, VT; and Blaine (Pacific Highway and Cargo

Ops), Lynden, Oroville, and Sumas (Cargo), WA.

Q. Will feeder cattle and feeder sheep and goats

imported from minimal-risk regions require identification

before they cross the border?

A. Yes. Feeder cattle must be permanently marked

with a brand to identify the BSE minimal-risk region

of origin before entering the United States. Feeder

cattle exported from Canada must be branded with

"C/\N" and feeder sheep and goats from Canada will

be branded with "C."

In addition, all feeder cattle and feeder sheep

and goats imported from minimal-risk regions must

be individually identified by an official eartag of the

country of origin. The eartag must be applied before

the animal’s arrival at the port-of-entry into the United

States, meet U.S. eartag standards, and be traceable

to the animal’s premises of origin. No person

may alter, deface, remove, or otherwise tamper with

the individual identification while the animal is in the

United States or moving through the United States.

Q. Will Canadian products be labeled with their

country of origin?

A. All Canadian ruminant products and byproducts

will need to have the proper import documentation

when they cross the border into the United States.

However, these products won’t be labeled with their

country of origin when they reach the consumer.

It is important to remember that imported meat

products are subject to the same stringent food

safety standards as domestic products. Foreign

countries must undergo a stringent review process

before they become eligible to export meat, poultry,

or egg products to the United States.

The 2002 Farm Bill provided for country-of-origin

labeling for beef, lamb, pork, fish, perishable agricultural

commodities, and peanuts. However,

Public Law 108–199 (the FY 2004 Consolidated

Appropriations Act) delayed the implementation of

mandatory country of origin labeling (COOL) for all

covered commodities, except wild and farm-raised

fish and shellfish, until September 30, 2006. When

mandatory COOL goes into effect for beef, it will

apply to all appropriate Canadian ruminant products

and byproducts.

Q. What safeguarding measures does the rule

require for the importation of live Canadian cattle

for immediate slaughter?

A. Canadian cattle imported for immediate slaughter

must be less than 30 months of age when imported.

They must be accompanied by a health certificate,

attesting to their age and relating to animal identification,

origin, destination, and responsible parties.

Cattle for immediate slaughter must move directly

as a group from the port of entry to a recognized

slaughtering establishment in sealed containers. They

must be slaughtered as a group, and all appropriate

specified risk materials as defined by USDA’s

Food Safety and Inspection Service (FSIS) must be

removed.

Q: What happens if a bovine animal over 30

months of age enters the United States from

Canada?

A: USDA thinks such a scenario is very unlikely due

to the fact that each animal presented at slaughter

comes in under sealed containers and with a veterinary

health certificate attesting to the age and health

condition of the animal. If the animal is determined

to be over 30 months of age, it will be properly disposed

of and will not enter the human or animal food

chains.

As noted in the March 2004 notice reopening the

comment period on the proposed minimal-risk region

rule, APHIS is currently evaluating the appropriate

approach regarding live cattle 30 months of age and

older and intends to address that issue in a separate

rulemaking proceeding in the Federal Register.

Q. Will Canadian cattle be tested for BSE in the

United States?

A. BSE testing in the United States is conducted for

animal health surveillance purposes. The current

enhanced surveillance program focuses on obtaining

samples from the targeted population of cattle where

the disease is most likely to be found—in adult animals

that have some type of clinical abnormality that

could be consistent with BSE. Because of the nature

of the disease and limitations of current BSE testing

technology, testing clinically normal animals does not

provide any significantly meaningful information for

surveillance purposes. In addition, the BSE test cannot

be considered a food safety test.

If any Canadian cattle fit our targeted population

as described, they will be subject to sampling under

the enhanced BSE surveillance program. This would

include any cattle condemned by FSIS at antemortem

examination.

Q. If Canada discovers additional cases of BSE,

will the border be closed again?

A. Should another case of BSE be discovered, any

actions taken by USDA will depend on the facts and

circumstances of the situation, an analysis of these

facts and circumstances, and Canada’s subsequent

response to the detection.

Q. How will the amended regulations affect transshipment

of domestic ruminants and ruminant

products through Canada to Alaska?

A. This regulation will not affect the transshipment of

domestic ruminants and ruminant products through

Canada to Alaska. Earlier this year, the Canadian

Food Inspection Agency (CFIA) began allowing the

temporary entry of live cattle under conditions that

included the USDA’s assurance that the animals

would return to the United States. Accordingly, all

BSE-based restrictions that prohibited the transshipment

of ruminant livestock from the lower 48 States

to Alaska via Canada were lifted. However, CFIA’s

regulations pertaining to the humane transport of

livestock continue to preclude the transshipment of

livestock by land via Canada.

Q. What process did USDA use to amend these

regulations?

A. USDA amended the regulations through the

Federal rulemaking process. USDA first proposed

changes to its regulations regarding establishing

minimal-risk regions and conditions for safely importing

certain live ruminants and ruminant products

from such regions on November 4, 2003, and the

comment period was still under way when the United

States announced its first case of BSE on December

23, 2003, in a cow imported from Canada. To allow

additional time for commenters to evaluate the proposal

in the context of the first U.S. finding of the

disease, USDA reopened the comment period and

accepted comments until April 7, 2004.

Q. Is USDA confident that the final rule will continue

to safeguard U.S. public and animal health?

A. USDA conducted a thorough, scientific assessment

of the risk of certain types of Canadian ruminants

and ruminant products introducing BSE into

Safeguarding American Agriculture Animal and Plant Health Inspection Service • United States Department of Agriculture •

the United States. This risk assessment included

consideration of the risk-mitigation measures Canada

has in place, the risk-mitigation measures in the

United States, and also the risk-mitigation measures

imposed in this final rule. USDA determined that

allowing the importation of Canadian ruminants and

ruminant products under the conditions imposed by

the rule will continue to protect against the introduction

of BSE into the United States and protect human

and animal health.

Q. Is USDA working with any other agencies to

implement these regulations? How will USDA

implement this rule?

A. USDA’s Animal and Plant Health Inspection

Service (APHIS) is finalizing preparations to implement

the rule and will have these in place by Monday,

July 18, 2005.

APHIS and FSIS have worked closely together

throughout the rulemaking process and have agreed

on certification language for ruminant products

and prepared importer information. These will be

posted to the APHIS Web site on July 15, 2005.

Stakeholders can find out more about importing animal

products by going to gov/lpa/issues/bse/trade/Dear_Product_importer.

pdf>.

USDA has also coordinated these regulations

with the U.S. Department of Health and Human

Services’ (HHS) Food and Drug Administration. In

addition, APHIS will be working closely with the U.S.

Department of Homeland Security’s Customs and

Border Protection to ensure that the regulations and

policies are clear to those performing inspections at

the border.

Q. Will other countries be categorized as minimalrisk

regions in the future?

A. Other countries that meet the conditions necessary

to be recognized as a minimal-risk region will

be considered in the future. The designation of any

future countries as minimal risk will be accomplished

in the same manner as Canada—through risk analysis

and appropriate rulemaking.

Q. What is the risk of allowing cattle to enter from

Canada?

A. The risk of BSE being introduced and spread

through cattle imported under the provisions of this

rule is absolutely minimal. The risk analysis conducted

demonstrates that Canada has taken appropriate

risk mitigation measures and that the possible prevalence

of BSE circulating in Canada is extremely low.

The risk of introduction is further lessened by the

specific import restrictions imposed on animals and

animal products imported under this rule. In addition

to these measures, there are measures in place in the

United States, such as the ruminant-to-ruminant feed

ban, that prevent the disease from spreading into the

U.S. domestic cattle population in the highly unlikely

even that it is introduced.

The risk is further mitigated by five interlocking,

overlapping, and sequential risk barriers applied at

critical control points. For an infected Canadian animal

to transmit infection to a U.S. cow, five barriers

must be crossed: (1) U.S. import restrictions;

(2) slaughter controls; (3) rendering inactivation;

(4) feed manufacturing controls; and (5) dose limitations.

Since the risk of infectivity circulating in

Canada is already minimal, each of these barriers

will further reduce that risk, leading to a very small

residual risk.

Q. Where can the public view a copy of the final

rule?

A. The final rule is available online at aphis.usda.gov/lpa/issues/bse/bse.html>.

Q. Where can the public view a copy of the risk

assessment?

A. The risk assessment is available online at www.aphis.usda.gov/lpa/issues/bse/bse.html>.

The U.S.Department of Agriculture (USDA) prohibits discrimination

in all its programs and activities on the basis of race, color, national

origin, sex, religion, age, disability, political beliefs, sexual orientation,

or marital or family status. (Not all prohibited bases apply to

all programs.) Persons with disabilities who require alternative

means for communication of program information (Braille, large

print, audiotape, etc.) should contact USDA’s TARGET Center at

(202) 720–2600 (voice and TDD).

To file a complaint of discrimination, write USDA, Director, Office of

Civil Rights, Room 326–W, Whitten Building, 14th and Independence

Avenue, SW, Washington, DC 20250–9410 or call (202) 720–5964

(voice and TDD). USDA is an equal opportunity provider and

employer.

http://www.aphis.usda.gov/lpa/pubs/fsheet_faq_notice/faq_ahbse_minrisk.pdf

no sound science here, just more BSe. nothing but commodities and futures...TSS

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


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


From: TSS ()
Subject: MAD COW FEED BAN WARNING LETTER USA June 9, 2005
Date: July 5, 2005 at 8:46 am PST

Department of Health and Human Services Public Health Service
Food and Drug Administration

Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612) 758-7119
FAX: (612) 334-4142


June 9, 2005

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 05-15

Michael J. Langenhorst
President
Anamax Corporation
P.O. Box 10067
Green Bay, WI 54307

Dear Mr. Langenhorst:

Our inspection of your rendering plant located at 505 Hardman Avenue South, South St. Paul, Minnesota, from January 12-20, 2005, revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations , Part 589 .2000 (21 CFR 589 .2000), Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Because you failed to follow the requirements of this regulation, products being manufactured and distributed by your facility are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(4)], and misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)].

Our investigation found that you failed to provide for measures to prevent commingling or cross-contamination and to maintain sufficient written procedures [21 CFR 589.2000(e)] in that:

1. You failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues into feeds that may be used for ruminants.

2. You failed to maintain written procedures specifying the clean-out procedures or other means to prevent carryover of protein derived from mammalian tissues into feeds that may be used for ruminants.

Our investigation also found that you failed to label products that may contain protein derived from mammalian tissues with the statement, "Do not feed to cattle or other ruminants." For example, your Feather Meal and Stabilized Poultry By-Product Meal lack this statement, even though the absence of sufficient measures to avoid commingling or cross-contamination may result in these products containing protein derived from mammalian tissues. Because your products do not bear this caution statement, they are misbranded under Section 403(a)(1) of the Act [21 U.S .C. 343(a)(1)).

The above is not intended as an all-inclusive list of violations. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring that your overall operation and the products you manufacture and distribute are in compliance with the law.

You should acknowledge this letter within 15 working days of receiving and include any additional corrective actions concerning your facility. We have received your letter dated January 31, 2005, which replies to the Form FDA-483 issued on January 20, 2005, and your letter dated February 25, 2005, that states all corrections have been implemented. The corrections you have reported appear to be adequate but will be evaluated further during our follow-up inspection.

Your response should be directed to Compliance Officer Jane E . Nelson at the address on the letterhead. If you have any questions regarding this letter, you may phone Ms. Nelson at (612) 758-7119.

Sincerely,

/S/

W. Charles Becoat
Director
Minneapolis District


http://www.fda.gov/foi/warning_letters/g5373d.pdf


TSS




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