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Subject: BSE NORTH AMERICA HEARING BEFORE THE COMMITTEE ON AGRICULTURE STATEMENT OF MIKE JOHANNS MARCH 1, 2005
Date: October 30, 2006 at 12:07 pm PST

REVIEW OF THE USDA’S RULE

PROVIDING FOR CANADIAN BEEF AND

CATTLE IMPORTS

HEARING

BEFORE THE

COMMITTEE ON AGRICULTURE

HOUSE OF REPRESENTATIVES

ONE HUNDRED NINTH CONGRESS

FIRST SESSION

MARCH 1, 2005

Serial No. 109–1

snip...

STATEMENT OF MIKE JOHANNS

Chairman Goodlatte, Mr. Peterson, Members of the Committee, thank you for

holding this important hearing today and for the opportunity to testify before you.

Accompanying me today are Dr. Keith Collins, USDA’s Chief Economist and Dr. Ron

DeHaven, Administrator of USDA’s Animal and Plant Health Inspection Service

(APHIS). They will be available to assist me in answering any questions you might

have.

Before I begin, I want to thank you for the close, positive working relationships

that we have begun forging. It is a pleasure to appear in my first hearing before

this committee as Secretary, and I look forward to building upon the productive

foundation that we are establishing on behalf of American food and agriculture.

I have said frequently that addressing Bovine Spongiform Encephalopathy (BSE)

issues, particularly as they relate to trade disruptions, would be my top priority as

Secretary. The actions that the U.S. Department of Agriculture and the Federal

Government are taking in regard to BSE are potentially precedent-setting and could

affect international trade patterns for years to come, with important economic implications

for our cattle producers and the entire beef industry. Therefore, our actions

must be undertaken with the utmost deliberation, using science as the basis. In the

absence of that scientific-foundation, sanitary and phytosanitary (SPS) restrictions

will be used arbitrarily by many nations, without any basis of protecting human,

animal and plant life and health.

Accordingly, this hearing could not be timelier, and I appreciate the opportunity

it provides to closely examine some useful and valid questions. I want to be very

clear that while protecting human and animal health must remain our top priorities,

I am confident that we can seek to return to normal patterns of international

commerce in beef and cattle by continuing to use science as the basis for decision

making by U.S. regulatory authorities and our trading partners.

Almost one year ago, on March 8, 2004, USDA published a notice reopening the

comment period on a rule to establish minimal-risk regions for BSE (the minimalrisk

rule), following the December 23, 2003, discovery of a single case of BSE in the

United States in a cow of Canadian origin.

In the time since then, much has transpired:

On March 15, 2004, consistent with the recommendations of an International Review

Team (IRT) of scientific advisers, USDA announced that beginning June 1 it

would implement an enhanced BSE surveillance program to test as many high-risk

animals as possible over a 12- to 18-month period. We wanted once and for all to

clearly ascertain whether we had BSE in our cattle herd and, if so, how prevalent

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it might be. USDA began the work of setting up the infrastructure required, including

laboratory equipment and certification, staff training, outreach efforts, and licensing

and approval of rapid tests. The plan was reviewed by the IRT, which characterized

it as ‘‘comprehensive, scientifically based and address[ing] the most important

points regarding BSE surveillance in animals.’’

On June 1, 2004, the enhanced surveillance program began. Our goal is to test

as many high-risk cattle as possible in 12–18 months. If we test 268,500 high risk

animals we will be able to detect the presence of as few as five targeted, high-risk

cattle with BSE at a 99 percent confidence level. At the time, USDA officials consistently

stated that the surveillance plan might uncover additional BSE-positive animals.

To date, some nine months later, more than 242,000 high-risk animals have

been tested, all of which have been negative.

In order to help raise awareness among animal-health professionals and livestock

producers about potential BSE cases, education and outreach have also been critical

components of these efforts. These activities have included advertisements in industry

publications, media articles, presentations at trade shows, and other materials.

The role of producers, renderers and others in helping obtain samples of high-risk

animals has been indispensable to the success of our surveillance program, and the

cooperation we have received has been outstanding.

On December 29, 2004, USDA announced the final rule establishing minimal-risk

regions, which designated Canada as the first minimal-risk region for BSE, and

which will become effective on March 7, 2005. Preparations are currently underway

to ensure a coordinated and orderly reopening of the border on that date.

On January 2, 2005, Canada confirmed its second domestic case of BSE in a cow

that was born in October of 1996 (the first since May 20, 2003). It was followed nine

days later by a third case, an 81-month-old cow.

On January 24, 2005, USDA dispatched a technical team to Canada. We sent the

team to investigate the efficacy of Canada’s ruminant to ruminant feed ban because

the animal was born shortly after the implementation of that ban and to determine

if there are any potential links among the positive animals. We have appreciated

Canada’s willingness to cooperate and assist us in these efforts.

The team was composed of experts from APHIS and other relevant, partner agencies.

Just last week, on February 25, we released the results of the investigation relating

to Canada’s feed ban. Based on a review of inspection records and on-site observations,

the team found that Canada has a robust inspection program, that overall

compliance with the feed ban is good, and that the feed ban is reducing the risk

of transmission of BSE in the Canadian cattle population. Where isolated issues

were found to exist, they were related mostly to areas of documentation and recordkeeping.

The team’s final epidemiological report investigating possible links of the positive

animals is still pending, and will be helpful as USDA proceeds with a rule allowing

imports of live cattle from animals 30 months of age and over.

THE MINIMAL-RISK RULE

As you are aware, USDA’s minimal-risk rule has come under legal challenge. I

will address the process of promulgating the rule, which was transparent, deliberative

and science-based.

Two rounds of public comment were conducted on the rule, with more than 3,300

comments received.

The final rule establishes criteria for geographic regions to be recognized as presenting

minimal risk of introducing BSE into the United States. It places Canada

in the minimal-risk category, and defines the requirements that must be met for the

import of certain ruminants and ruminant products from Canada. A minimal-risk

region can include a region in which BSE-infected animals have been diagnosed, but

where sufficient risk-mitigation measures have been put in place to make the introduction

of BSE into the United States unlikely.

As you are aware, the rule originally allowed the import of beef products from animals

of all ages. However, on February 9, 2005, because our investigation in Canada

would not be complete by March 7, I ordered that the portion of the rule allowing

beef products from animals 30 months and over be delayed. USDA plans to move

forward expeditiously with a plan including rule-making to allow imports of live cattle

from animals over 30 months of age and over.

Because the rule that goes into effect on March 7 allows the import of live cattle

under 30 months of age, it is useful to note the risk mitigation measures. These include:

proper animal identification; accompanying animal health certification that

includes information on age, origin, destination, and responsible parties; the move-

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ment of the cattle to feedlots or slaughter facilities in sealed containers; the prohibition

on cattle moving to more than one feedlot in the United States; and just as

in U.S. cattle, the removal of specified risk materials (SRMs) at slaughter.

For live sheep and goats under 12 months of age, all of the same mitigation measures

apply, except for the requirement that SRMs be removed from the animal at

slaughter.

We remain very confident that the combination of all of these requirements, in

addition to the animal and public health measures that Canada has in place to prevent

the spread of BSE, along with the extensive U.S. regulatory food-safety and

animal-health systems, provide the utmost protection to U.S. consumers and livestock.

USDA continues to undertake several steps to ensure Canada’s compliance with

its BSE regulations. In addition to the investigation that I already discussed,

USDA’s Food Safety and Inspection Service in December 2004 conducted an intensive

audit of Canada’s compliance with the BSE requirements of the United States,

with particular attention to SRM removal. FSIS visited several facilities that

slaughter cattle under 30 months of age and determined that they are effectively

implementing the BSE regulations.

Last month, FSIS conducted a similar BSE audit of Canadian plants that slaughter

cattle 30 months and older. Canada currently has only seven such plants that

are certified to export meat to the United States.

THE ROLE OF SCIENCE

I simply cannot emphasize strongly enough the central role of science in this entire

process, particularly with regard to the rigorous evaluation of risk.

Since the discovery of the first case of BSE in Great Britain in 1986, we have

learned a tremendous amount about this disease. That knowledge has greatly informed

our regulatory systems and response efforts.

We have learned that the single most important thing we can do to protect human

health regarding BSE is the removal of SRMs from the food supply. It is because

of the strong systems the United States has put in place already, especially the removal

of SRMs from the human food supply and the prohibition of ruminant and

certain other animal proteins in ruminant feed, that we can be confident of the safety

of our beef supply and that the spread of BSE has been prevented in this nation.

After Canada reported its first case of BSE in May 2003, USDA conducted a comprehensive

risk analysis to review the potential threat it posed. The initial analysis

followed the recommended structure of the World Organization for Animal Health,

or OIE, and drew on findings from the Harvard-Tuskegee BSE risk assessment,

findings from the epidemiological investigation of BSE in Canada, and information

on Canadian BSE surveillance and feed ban, and history of imports of cattle and

meat and bone meal from countries known to have BSE.

The results of that analysis, available on the USDA Website, confirmed that Canada

has the necessary safeguards in place to protect U.S. consumers and livestock

against BSE. These mitigation measures include the removal of SRMs from the food

chain supply, a ruminant-to-ruminant feed ban, a strong national surveillance program

and import restrictions. The extensive risk assessment conducted as part of

USDA’s rulemaking process also took into careful consideration the possibility that

Canada could experience additional cases of BSE.

In the risk analysis update for the final rule, USDA also considered the additional

risk protection from new slaughter requirement procedures, such as the prohibition

on the use of downer animals for food.

The public commented on the risk assessment that accompanied the proposed rule

and the Explanatory Note released following the finding of BSE in a cow in Washington

State. Over a period of months, USDA carefully considered these comments,

and responses were published with the final rule. The comments were beneficial to

the final risk analysis. The risk analysis was reviewed internally at USDA and by

Dr. William Hueston, an international expert on BSE and a member of the International

Review Team.

The OIE recommends the use of risk assessment to manage human and animal

health risks of BSE. OIE guidelines, based on current scientific understanding, recognize

that there are different levels of risk in countries or regions, and suggest how

trade may safely occur according to the levels of risk. USDA used the OIE guidelines

as a basis in developing our regulations defining Canada as a minimal risk

country.

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CATTLE AND BEEF TRADE IMPACTS

While SPS regulations protecting human and animal health are the foremost concern,

USDA also has examined the potential economic impacts of the minimal-risk

rule and related BSE trade issues, as required by Executive Order 12866.

For more than three months following the May 20, 2003, BSE discovery in Canada,

all imports of Canadian ruminants and ruminant products were barred. Then,

certain Canadian ruminant products for which there is inherently lower risk were

allowed to enter under permit beginning August 2003.

For all of 2003, the United States imported 336,000 metric tons of beef from Canada.

Imports increased to an estimated 476,000 metric tons in 2004, up nearly 42

percent and back to about the level that prevailed in years prior to 2003.

Because the border has been closed to live cattle since May 2003, imports of fed

and feeder cattle under 30 months are expected to increase over historic levels in

2005, which is expected to drive up U.S. beef production, reduce beef prices slightly

and, consequently, reduce cattle prices. The cost-benefit analysis of the original

minimal risk rule was based on Canada’s cattle population as of July 1, 2004, and

the cross-border price differential at that time. USDA now estimates that about 1.3

million Canadian animals may be imported in all of 2005, down from previous estimates

of 1.5 million to 2 million head.

In addition, delaying the effective date for resuming import of beef products from

animals over 30 months has narrowed our projection of price effects. We now project

a decline in fed cattle prices of 2.6 percent lower than if no additional trade in live

cattle were to occur, down from 3.2 percent in the earlier projection. The projection

also assumes that Asian markets do not open to our beef during 2005.

The precise economic effects will depend on the timing and volume of cattle and

beef imports from Canada. If USDA’s price forecast turns out to be correct, that

would be the third-highest annual fed cattle price on record. Cattle futures prices

may be less affected than indicated by our forecast, as market prices have likely already

reflected some probability of the border opening.

At the same time, I have been concerned about the effect that the closure of the

border has been having on the restructuring of the cross-border beef industry. We

are already seeing additional processing capacity in Canada, and further delays will

only exacerbate that trend, leading to long-term change.

In addition, to the extent that we can continue to open markets that are currently

closed to our beef, U.S. cattle price prospects will strengthen.

U.S. market-maintenance activities have been critical in helping restore our beef

export markets. In 2003, the total export value of U.S. beef and ruminant products

was $7.5 billion. After December 23, 2003, 64 percent of that market was immediately

closed. Today, we have recovered well over a third of that, so that 41 percent

of that market ($3.1 billion) remains closed. Two countries—Japan ($1.5 billion) and

Korea ($800 million)—account for nearly three-quarters of the existing closures.

OPENING THE JAPANESE MARKET

As a leader in the critical Asian markets, Japan is a vital market to reopen to

U.S. beef exports. We are aware that the decision to resume trade in this market

will set an important precedent for trade resumption in many other markets. Therefore

we have endeavored to use science in our ongoing efforts. Efforts to re-open this

market have drawn on resources across the Federal Government and at the highest

political levels. As I have previously said, this issue has occupied much of my first

few days as Secretary. Just last week, I met with Ambassador Kato and also wrote

to my counterpart, Minister Shimamura, on the importance of this issue. At the

same time, Ambassador Baker continued to press this issue with Government of

Japan officials until his very last days in Tokyo, and other U.S. Government officials

continue to contact their counterparts. On February 19, Secretary of State Rice personally

raised this issue in a meeting with the Japanese Foreign Minister.

These efforts are just the latest in many policy discussions and technical exchanges

over the past 13 months. Indeed, the issue has been a major focus of direct

discussions between President Bush and Japanese Prime Minister Koizumi.

On October 23, 2004, Japan and the United States developed a framework to

allow the resumption of bilateral beef trade following the conclusion of regulatory

processes in both countries. As a step toward the resumption of normal trade, the

agreement establishes an interim special marketing program, known as the Beef

Export Verification (BEV) Program, to allow the United States to sell beef and beef

products to Japanese importers from animals 20 months of age and under. Animal

age will be determined through a combination of production records and physiological

(grading) means. We are now working with Japanese officials to gain approval

of the BEV under their regulatory process.

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I have repeatedly pressed Japanese officials to set a date certain for the resumption

of U.S. beef exports to Japan. However, additional requests from Japan for data

regarding grading and the plodding regulatory process that Japan insists on using

could delay that process. Additional delays could further complicate relations between

the United States and Japan.

While we are focusing on Japan because of our important trading relationship and

its leadership role in the region, we are also pursuing efforts to reopen all of the

markets that have been closed to us. We are actively engaged with Korea, Hong

Kong, Taiwan, China, Egypt, and Russia and have specific actions underway in each

market to get trade resumed. I would be pleased to provide Members upon request

additional detail on these and other secondary markets. While the progress that has

been made has taken far longer than we had hoped, progress is indeed being made.

And, I have stated that USDA, and indeed the entire U.S. Government, will exert

every effort to resolve the matter at the earliest possible time.

As traditional trade barriers such as tariffs are lowered, our focus to eliminate

unjustified non-tariff barriers such as non-science based SPS regulatory measures

become all the more important to maintain the flow of mutually beneficial trade.

For USDA, a common touchstone across these issues is the need to maintain consistency

and predictability, to base our domestic regulations on science and to encourage

the use of science-based solutions within the international community. The

United States has long been a leader in this regard, including negotiating the World

Trade Organization Agreement on the Application of Sanitary and Phytosanitary

Measures during the Uruguay Round.

Even before the discovery of a single case of BSE in the United States, USDA had

begun talking with other countries about the need for international trade standards

to keep pace with the science, and we will redouble our efforts in this regard.

It is also critical that domestic trade rules reflect the current state of knowledge

regarding BSE, and here the United States is leading, as well. We are confident

that trade can be resumed with countries where BSE has been discovered, contingent

upon strong protections within those countries, as well as the robust and effective

regulatory system those imports are subject to when they enter the United

States. These facts are reflected in the minimal-risk rule.

At the same time, we will continue to work with our trading partners to ensure

the ongoing strength of their own BSE protection systems, especially the removal

of SRMs and implementation of the feed ban. While trade opportunities are multiplying

in an increasingly global marketplace, we must always remain mindful of

our paramount responsibility to protect the public health and animal health.

In summary, I am confident that we are continuing to keep the protection of public

and animal health foremost in our concerns. It is critical that we continue to use

science as a basis for our decisions and regulations, and that the United States

maintain its leadership role in advancing our scientific understanding of these kinds

of SPS-related issues and appropriate science-based responses.

Mr. Chairman, thank you once again for holding this important hearing. I would

now be pleased to take any questions you or other members may have.

ANSWERS TO SUBMITTED QUESTIONS

1. Now that APHIS has established a rule establishing criteria for regions

to be recognized as presenting minimal risk of introducing BSE into the

United States, do you plan to categorize additional countries as either

minimal risk, moderate risk, high risk, or BSE free? If so, is there a chance

your list would be different form the OIE’s list of BSE free or provisionally

free countries? How might this affect the current restrictions we have in

place on the importation of specified-risk materials?

Response: APHIS’s current regulations on BSE lists countries in two categories.

These are countries affected with BSE, and countries presenting undue risk for

BSE. Import restrictions are the same for these two listings. These regulations

would have to be amended, through a formal rulemaking process, to add any additional

categories or to re-define the existing categories. An example of this is the

recent final rule that would establish a minimal risk category and add Canada to

that category.

At this time, no country besides Canada has asked the United States to conduct

a thorough and exhaustive assessment to evaluate its overall BSE risk and to

change its regulatory status. This is the first step in considering whether to allow

live cattle and beef imports from a country where BSE has been identified. Other

countries may request APHIS to change their status in the future.

The World Organization for Animal Health’s (OIE) list of BSE-free and provisionally-

free countries is not intended to be comprehensive. OIE will examine, upon re-

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quest from a member country, its claims for a particular BSE status. Currently, the

OIE will only examine a country’s claim for BSE free or provisionally-free status,

and will not classify any country as low, moderate or high risk for BSE. Only a

handful of countries have asked for such an evaluation to be endorsed as BSE-free

or provisionally-free, and four countries have actually completed the evaluation.

The current OIE Code Chapter on BSE provides guidelines for five classifications

of countries. Member countries are free to use these guidelines to help determine

their trading partners’ overall BSE risk. However, it is important to keep in mind

that as a result of the recommendations made by the expert ad hoc group on BSE,

the OIE is presenting, for adoption at its May 2005 General Session, a revised Code

Chapter with three BSE classifications: negligible risk without mitigations; negligible

risk with mitigations; and undetermined risk.

Finally, with regard to your question about the importation of specified-risk materials

(SRMs), the removal of SRMs is one of the most critical components of an effective

BSE prevention program in terms of protecting public health. The U.S. has

issued interim final rules requiring the removal of SRMs from all cattle. USDA and

DHHS/FDA are evaluating comments received on those rules.

2. Why did APHIS diverge from the OIE recommendation to require that

a feed ban be in place for at least 8 years in order for a country to be considered

a minimum risk country? Was there a concern that inclusion of

such a requirement would make the rule vulnerable to challenge in the

WTO on the grounds that it was not based on science?

Response: The OIE standards are not intended to be used as a check list, rather

they are intended as a set of guidelines that allow countries the flexibility to develop

their own tailored regulations for protecting public and animal health. The standards

should be used to help a country identify and evaluate, through a risk assessment,

all of the potential risk factors for BSE and their management. The outcome

of such a risk assessment can be used to determine whether an alternative risk

management measure could be applied to achieve the same level of protection.

An effective feed ban is a key component of both the OIE guidelines set forth to

establish a country as a minimal-risk region for BSE and of USDA’s criteria to define

a BSE minimal-risk region. USDA has acknowledged that Canada’s feed ban

falls some months short of the 8-year recommendation. However, Canada has had

a comprehensive feed ban in place for more than 7 years. Furthermore, the feed ban

is just one component of a much larger system of safeguards that includes, among

others, surveillance and specified risk material removal. In keeping with the OIE

Code, these risk mitigation measures are considered in their totality for their ability

to work as a series of interlocking, overlapping and sequential steps to prevent the

introduction and establishment of BSE.

The OIE standards are intended to be used as guidelines to assist countries in

using the underlying scientific knowledge on BSE. USDA is not concerned that the

minimal risk rule is vulnerable to challenge in the WTO. USDA conducted a thorough

and exhaustive risk analysis and our decision to allow live cattle and beef imports

from Canada was based on science with the protection of public and animal

health being our highest priority.

3. The USDA audit of Canada’s feed ban says that the ban was implemented

on August 4, 1997, ‘‘with provisions for a phase-in period so that existing

stocks of feed material could be depleted. Feed mills were allowed

a 30-day period to use and distribute existing stocks, while farms were allowed

60 days to use existing stocks. No recall was ordered for products

that were already in the production or distribution chain...’’. The last BSE

cow would have been fed starting sometime after its birth in March 1998.

Doesn’t this show that the ban was not effective?

Response: On February 25, 2005, USDA released the final report of the technical

team that reviewed the feed ban in Canada. The technical team found that Canada

has a robust feed ban inspection program, that overall compliance with the feed ban

is good, and that the feed ban is reducing the risk of transmission of BSE in the

Canadian cattle population. The risk analysis conducted for the minimal risk rule

concluded that the feed ban is effective. It should be noted that this analysis did

not assume 100 percent compliance with the feed ban, as that is not realistic in any

situation. The information provided by the U.S. team verifies the information cited

in the risk analysis, and supports the conclusion that the feed ban is effective.

The Canadian feed ban restricts the use of most mammalian-origin protein in ruminant

feed. It was implemented in 1997, and similar to the U.S. feed ban, was put

in place as a proactive, preventive measure. Achieving full compliance with a feed

ban inevitably takes time, due to complexities of the regulations and the industries

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involved. International authorities generally recognize that it may take 6 months or

longer to completely clear out any remaining feed from the old system after a feed

ban is implemented. It also takes time before the feed and livestock industries are

able to fully meet the record-keeping and labeling requirements in the feed ban, and

the requirements for preventing cross-contamination.

4. Despite a rigorous surveillance program, that has tested many more

cattle than in Canada we have not found a single case of BSE in a U.S.-born

cow. Canada has found three cases so far. Does this mean that Canada’s

testing program is more effective at finding the disease, or does it mean

that BSE is more prevalent in Canada than in the United States?

Response: The United States is still in the midst of an intensive one-time enhanced

surveillance effort that will provide a snapshot of the domestic cattle population

to help define whether BSE is present in the United States, and if so help

calculate at what level. It is possible that during the course of this intensive surveillance,

we may find a case of BSE in a native U.S. animal. When USDA kicked off

our enhanced surveillance in June, 2004, we were clear in stating this possibility.

At the same time our current results are promising. As of May 1, 2005, we have

tested 339,271 cattle and all have tested negative for BSE.

USDA has not made a prediction about the number of cases the United States

or Canada might find as a result of ongoing surveillance. Rather, this effort is intended

to give the United States a better understanding of the prevalence of the

disease and the same is true for Canada. Surveillance is a key component of any

BSE program, providing a way to monitor the effectiveness of the various risk mitigation

measures, which is why the United States and Canada are conducting such

thorough surveillance. Additional information from continuing an epidemiological

study in Canada may provide more insight into whether the BSE exposure was an

isolated or clustered incident, or whether it may be more widespread. There are currently

no indications that it is widespread, nor do analyses indicate that the disease

continues to spread and amplify given current risk mitigation measures. We would

note that since the start of their enhanced surveillance program, Canada has tested

approximately 45,000 animals to date. Given the relative herd size in Canada in relation

to the size of the U.S. cattle herd, we believe Canada is achieving comparable

sensitivity in their enhanced surveillance program.

5. After Canada reported its first BSE case in May 2003, a scientific International

Review Team there recommended that stronger feed measures be

put into place. Why did Canada wait until December 2004 to propose a new

rule to also prohibit specified risk material (SRM) in all animal feeds?

Response: The changes proposed by Canada are significant, and would require restructuring

of the animal disposal industry. If regulations are established which

completely prohibit the use of certain products, alternative disposal options must be

available and in place at the time the regulations are implemented. The Canadian

government appropriately has taken time to consider all of the implications, costs

and benefits of any such changes. The Canadian government has been carefully considering

various options in consultation with a wide variety of interests, including

various industry groups, provincial representatives, other agencies, and international

counterparts.

It is important to note that Canada’s existing feed ban is effective, and based on

current scientific consensus, would lead to the eradication of BSE. The Canadian

government believes that the proposed changes will simply lead to a faster rate of

progress to eradication. Canada has noted that the relative probabilities of further

transmission of BSE to other animals and, indirectly, exposure to people through

food or other human uses of rendered bovine tissues are low. Therefore, taking time

to thoroughly analyze any proposed changes allows an appropriate decision to be

made that has a better chance of successful implementation.

6. USDA’s assessment of the risk of BSE from Canadian imports was completed

before a cow with BSE was discovered in Washington State in December

2003. (In support of the rule proposed in November 2003 and finalized

January 4, 2005.) Why did USDA decide it was not necessary to alter

its risk assessment in light of this first U.S. finding?

Response: USDA conducted a risk analysis in October 2003 that was published

with the initial proposed rule. This analysis was updated in early 2004, and was

published as an ‘‘Explanatory Note’’ when the comment period on the proposed rule

was re-opened. This explanatory note fully considered the implications of the December

2003 case identified in Washington State, and concluded that the additional

case did not significantly alter the original risk estimate. Based on factors addressed

in the original risk analysis, and the risk mitigation measures (both existing and

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outlined in the proposed rule), it concluded that it was unlikely that BSE would be

introduced from Canada under the conditions described in the proposed rule. Finally,

the risk analysis was updated again in December 2004 and was published

along with the final rule.

7. In February, the Office of Inspector General (OIG) released its audit

of USDA’s oversight of beef imports from Canada. OIG reported that the

APHIS permit process was used to begin imports of Canadian beef products,

even though this process has always been intended for other, low volume

products. Why did USDA decide to use the permit process for the import

of large quantities of beef?

Response: Prior to the August 2003 announcement, USDA conducted a close review

of Canada’s exhaustive epidemiological investigation into the BSE case that

was reported by Canadian officials in May 2003. USDA also took into account the

international animal health guidelines set by the World Animal Health Organization

(OIE) and scientific literature regarding the pathogenesis and transmission of

BSE. Additionally, USDA reviewed the ongoing preventive measures that Canada

had in place prior to the detection of BSE and the additional risk mitigation measures

Canada put in place in response to a review of the investigation by an independent

expert panel.

After this review, USDA determined that the permitting process was an appropriate,

legal, and scientifically-sound vehicle for re-opening trade with Canada.

8. OIG reported that 42,000 pounds of beef ‘‘of questionable eligibility’’ entered

the U.S. from Canada after a May 2004 court agreement limited what

could be imported. How did this happen and what has USDA done to ensure

this won’t happen again?

Response: The situation you refer to was the result of confusion between APHIS

and FSIS about the eligibility of beef cheek meat. On several occasions, beef cheek

meat was allowed entry under import permits that indicated ‘‘boneless beef’’ due to

confusion over whether or not beef cheek meat was included in the definition of

‘‘boneless beef.’’ Although it is a low risk product and poses no safety risk to humans

or animals, APHIS and FSIS agreed with OIG’s recommendations regarding the

confusion and need for consistency in definitions in this case, and have implemented

or are implementing the following actions:

• On February 14, 2005, APHIS notified, by letter, holders of permits for ‘‘boneless

beef’’ that such permits do not allow the importation of cheek meat.

• FSIS will implement controls to communicate the specific eligibility of product

when the eligibility status changes. FSIS will complete the review and update of the

controls by July 2005.

• FSIS currently performs quarterly verification of its import information system

while monitoring and overseeing the system and import inspection program performance.

In addition, the import inspection system has a limited set of edit checks

that are presently incorporated in its current configuration. FSIS will enhance this

feature of the system by reprogramming the Automated Import Information System

(AIIS) to include drop-down menus containing a specific set of eligible products. The

reprogrammed system will eliminate product description from being entered into a

text field and thereby mitigate or restrict the possibility of ineligible product being

entered in the system. FSIS expects to complete the AIIS reprogramming by January

2006.

9. What was the basis for USDA making a conscious decision not to publicly

announce its Canadian import policy changes?

Response: APHIS recognizes that it was not timely in posting all updates during

the immensely busy period following the August 8, 2003, announcement. The Agency

will continue to move information through the previously established channels

described above and work to identify new and more efficient ways to ensure all interested

parties receive all necessary information regarding changes in import policy.

As we determine specific improvement regarding internal communication channels

we can use to ensure all web-based notifications are posted in a timely fashion,

we will document and implement those procedures.

10. OIG concluded that APHIS did not have a process to identify discrepancies

between agency practices and their publicly stated policies. How

will APHIS address this issue?

Response: APHIS has taken action to implement changes in addition to existing

procedures. APHIS’ Veterinary Services (VS) maintains standard operating procedures

(SOPs) and standardized permit language for drafting permits to ensure con-

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sistency. VS provides all permitting staff with a copy of the SOP manual and trains

staff accordingly. The permitting staff holds frequent meetings where experts discuss

and establish procedures for any emerging issues concerning importation of

animal origin material.

While these mechanisms have been very successful in the past, APHIS’ systems

were clearly strained under the unprecedented volume of permit requests after the

Secretary’s announcement.

VS has developed a refined tracking system and enhanced protocols to ensure that

staff will update the system whenever changes are made to policies, product certification

statements, and permit guidelines. Furthermore, FSIS and APHIS are in

close and constant contact to ensure parallel operations and definitions, where appropriate.

11–12. OIG criticized USDA for not documenting its decisions, failure to

communicate with other agencies, and inadequate internal controls over

the rulemaking process. Have all of OIG’s recommendations to fix these

problems been implemented?

Response: (Questions11–12) While many of OIG’s recommendations have already

been implemented following the identification of the problem, APHIS and FSIS continue

to work on several projects that will further address OIG’s concerns. The results

of these projects will be seen over the next year and include, among others:

• FSIS will include an edit check function in the automated import information

system by January 2006;

• FSIS will complete the review and update of communication controls by July

2005;

• APHIS is working to develop a new, sophisticated E-permits system by January

2006; and

• APHIS and FSIS will use consistent terminology by May 2005.

13. The Inspector General recommended that APHIS develop and implement

procedures for communicating policy changes to all interested parties,

including importers, Congress, and the public. APHIS states that it

will have refined procedures in place by late March. What changes is the

agency implementing, and will they be in place when anticipated?

Response: As part of the response to OIG, APHIS has agreed to consistently:

• Post ‘‘dear importer’’ letters on the Agency web page to notify interested parties

of changes to import policy;

• Issue alerts to Agency port personnel and Department of Homeland Security

Customs and Border Protection personnel, which is then provided to all their interested

parties;

• APHIS will work closely with FSIS and provide frequent policy updates and

work together to use consistent terminology when identifying products;

• Work with Congress to ensure that legislators are aware of import policy

changes.

APHIS has also committed to OIG that the Agency will have in place new procedures

to notify applicants of APHIS permits to remove or revise material and explain

the reasons for decisions. In order to facilitate this, the Agency will take and

has taken the following actions:

• National Center for Import and Export (NCIE) has implemented a mail-in tracking

system and enacted protocols to ensure that changes or updates to policies, product

certification statements and permit guidelines are documented.

• NCIE can now query the Permit Information Tracking System by shipper to

identify permits that need revision or cancellation.

• APHIS is developing a new, sophisticated E-permits system for use Agencywide.

This new system will be operational by January, 2006.

In order to ensure that risk mitigation measures are attached to permits, APHIS

intends to strengthen its current system to allow for a larger number of permits to

be handled within a limited time frame. To do this, APHIS has implemented the

procedures described above and will hire additional staff as funding allows to handle

any future situations where a large number of permits are received in a limited

amount of time (such as during the Canadian ruminant ban).

14. Canadian plants were required by USDA to have approved plans for

segregating eligible from ineligible products. OIG says that no Canadian facility

met this requirement. Have all the required plans now been submitted

by the Canadian plants?

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Response: The segregation plan requirement applied only to facilities that received

both ineligible and eligible beef cuts from which they derived processed product.

Only one facility that received and processed both ineligible and eligible cuts

of meat applied for a permit, and thus submitted a segregation plan. APHIS reviewed

the plan, had concerns with the plan, and, therefore, did not approve the

plan. APHIS did correctly issue permits to other facilities for processed product.

Again, however, because these facilities do not receive and process both ineligible

and eligible cuts, they were not required to submit a segregation plan.

15. In its report, OIG refers to a decision memorandum to permit ground

meat imports. In the memo, APHIS stated that the decision constituted a

significant change in policy that increased the likelihood of importing

higher risk products. Why was this decision made without the opportunity

for public comment? Who reviewed and approved the memo?

Response: The memo referenced was reviewed by APHIS management and was

seen as the processing in Canada of products that were already safe and approved

for export into the United States. While there was a slight risk of commingling with

ineligible products, the risk was mitigated by requiring certification by CFIA and

segregation plans. There was no food safety issue.

16. Several import decision memos discussed the meat industry’s concerns

about the beef import policy. Did they also discuss the concerns of

the cattle industry and of consumers?

Response: The safety of U.S. citizens and livestock is always the highest concern

when dealing with a disease such as BSE. All constituents’ concerns were thoroughly

considered.

17. What restrictions does Canada place on imports U.S. cattle related to

bluetongue and anaplasmosis concerns?

Response: For over 17 years, the United States has been working to achieve greater

access for U.S. feeder cattle to Canada. On October 22, 1997, the United States

and Canada announced a pilot project to facilitate exports of live cattle from participating

U.S. states to Canada. Under this project, exports of feeder cattle from the

United States were limited to a six-month shipping season, designated as a low-risk

vector season for bluetongue and anaplasmosis.

On March 10, 2004 Canada announced that it would remove anaplasmosis and

bluetongue testing and treatment requirements from feeder cattle imported from the

United States enabling year-round access to Canadian feedlots. Specifically, the

CFIA permit system that governs these imports would be changed. This new policy

will take effect when the BSE prohibition is lifted.

Under the new permit policy, U.S. feeder cattle from 39 states considered to have

a low incidence of bluetongue will be able to enter Canada directly without testing.

Feeder cattle from the remaining 11 states, which are considered to have a high incidence

of bluetongue will also not be required to test, provided that their cattle reside

in a low incidence state for at least 60 days prior to import. Testing can still

be used in these high incidence States, in lieu of residency in a low incidence State.

18. USDA is permitting cattle, and beef from cattle, under 30 months of

age to enter the United States from Canada. However, it also has agreed

to Japanese demands that the United States ship beef from cattle 20

months and younger. How are these policies consistent?

Response: Resumption of U.S. beef trade with Japan and reopening the border to

live cattle from Canada are separate and distinct trade issues. The BSE minimalrisk

rule is based on sound scientific principles in accord with OIE guidelines for

trade with BSE-affected regions. Negotiations with Japan have focused on smaller

steps to reopen a critical international market for U.S. producers. In October, 2004,

USDA announced an understanding with Japan to export meat from cattle 20

months of age or younger. This age limit falls is not based on internationally recognized

sound science. It is important to make clear that while we have agreed to the

20-month age limit as a marketing program, we continue to work with Japan on

a technical level regarding the specific terms of the understanding. In addition, an

international body of scientific experts is expected to review the terms of the export

marketing program in July 2005, at which time we expect to make a strong case

to move Japanese officials toward a scientifically sound policy.

It’s critical that even while USDA is accommodating Japan’s standards, we must

take the lead at home in establishing the concept of minimal-risk regions based on

scientific risk analyses for animal pests and diseases and push to have other countries

base their BSE measures on the OIE guidelines. In implementing the BSE

minimal-risk rule, the United States is taking a strong stand and seeking to ensure

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that all countries adopt science and risk-based import and export standards and

apply them equivalently and without discrimination. The United States cannot effectively

protest unjustified measures applied to our products if we similarly apply

the same virtually impossible measures to others.

19. How, specifically, will USDA ensure that Canadian beef from cattle

over 20 months is not co-mingled with beef destined for Japan? What procedures

will be in place to monitor Canadian products and ensure that all

import requirements are being met?

Response: Once an agreement is finalized with Japan, the Agricultural Marketing

Service (AMS) will develop a Beef Export Verification (BEV) program to ensure that

the terms of the agreement, such as appropriate segregation of products, age, are

met. A BEV program addressing the commingling issue was implemented for Japan

to accept U.S. beef after the first case of BSE was found in Canada in May 2003.

The Food Safety Inspection Service will take AMS’s verification and certify on a

U.S. export health certificate compliance with Japan’s import requirements. FSIS officials

assigned to the packing plants will have oversight responsibilities to ensure

all requirements are being met.

20. In its testimony, the National Cattlemen’s Beef Association (NCBA)

listed 11 criteria that would have to be met before it would support implementation

of the rule. How many of these criteria are achievable before the

implementation of the rule? Are these (or similarly rigorous) criteria something

that the Department would be comfortable having our foreign customers

requiring before they would accept U.S. beef and cattle products?

Response: We appreciate the proactive work of the National Cattlemen’s Beef Association

(NCBA) on this issue. Some of the recommendations, such as assurance

that all Canadian firewalls to prevent BSE are functioning properly, are relating to

the science of the rule, while others, such as the movement of Canadian cattle into

the U.S. must be managed to minimize market disruptions, are economic in nature.

USDA does not have the authority to promulgate rules solely on economic factors.

Rulemaking is done based on science; in this case, USDA’s risk assessment evaluated

the risk that opening the Canadian border to specific animals and products

would pose to animal and human health and determined it to be of minimal risk.

We must also stress that, in implementing the BSE minimal-risk rule, the United

States is taking a stand and seeking to ensure that all countries adopt science and

risk-based import and export standards and apply them equivalently and without

discrimination. The United States cannot effectively protest unjustified measures

applied to our products if we similarly apply the same virtually impossible measures

to others.

21. NCBA testified that the import ban on U.S. beef because of BSE has

cost U.S. cattlemen $4.8 billion over the 14 months that the ban has been

in place. Does USDA agree with this number? If so, does the calculation include

the net effect on beef prices from the U.S. import ban on Canadian

cattle entering the US? For example, Secretary Johanns’ written testimony

indicates that a removal of the ban, which will allow Canadian cattle under

30 months of age to enter the US, will reduce prices by 2.6 percent. Has the

U.S. ban on Canadian imports reduced $4.8 billion the impact on U.S.

cattlemen that NCBA calculated? If you do not agree with the NCBA number,

please provide your own estimate of the cost to U.S. cattlemen and explain

how you reached that number and specifically what effect the U.S.

ban on Canadian imports has had on the losses.

Response: USDA has not analyzed the impacts in NCBA’s assessment of the ban

on U.S. exports of beef due to the discovery of BSE. However, USDA has done some

partial estimates of the value of the loss of export sales of beef and loss of sales

value of fed cattle. This analysis estimates these lost exports sales of beef and beef

products at about $3.5–4 billion since December 2003. These lost exports sales do

not fully translate into lost sales value of fed cattle because beef that would have

been exported was consumed domestically. Thus, our analysis estimates lost sales

value of fed cattle of at $1.7–2.3 billion since the discovery of BSE in December

2003. There are also additional losses to the cow slaughter industry.

The assumptions underlying this estimate are as follows: Prior to the discovery

of BSE, USDA had forecast that beef exports would increase 1–2 percent in 2004.

Given strong demand for limited supplies of U.S. beef, prices may have been 5–7

percent higher than in the absence of expanded exports. The lost export volume was

offset by increased domestic beef consumption. Thus, the loss in the value of fed cattle

sales is the difference between the cattle price estimated to have prevailed had

the U.S. been able to export beef to all markets and the price that prevailed with

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export markets closed. Assuming fed cattle prices were reduced 5–7 percent by the

loss of export markets, the average fed steer price would have been reduced by

about $50-$70 per head. In 2004, 27 million head of fed steers and heifers were

slaughtered, and it is expected that an additional 6 million head will be slaughtered

in the first quarter of 2004, thus producers likely would have received an additional

$1.7-$2.30 billion for the fed cattle marketed had export markets not been lost. This

estimate may be conservative in that, given higher prices, producers may have chosen

to market a greater number of cattle. On the other hand, higher domestic beef

prices might have limited increases in U.S. beef demand. The U.S. generally does

not export nonfed beef, and it is likely that U.S. imports of nonfed beef may have

been higher with all export markets open, since Australia would not have diverted

exports to Asia to fill in behind the U.S.

U.S. cattle prices and the value of U.S. exports are supported by the current ban

on imports of Canadian cattle. In the absence of the ban, it is expected that U.S.

cattle prices and wholesale prices would have been lower than existed in the past

14 months. Thus, the value of forgone exports would have been less had there been

no ban on imports of cattle from Canada.

22. If this rule becomes effective, how do you anticipate it will change the

structure of Canadian beef exports to the US? —Will more or less of the

beef sourced by U.S. customers come as boxed beef, case-ready product,

chilled sides or live cattle?

Response: If the minimal-risk rule becomes effective, it likely will lead to initial

increases in imports of live cattle as Canada works through its backlog of animals

under 30 months old. However, as inventories of backlogged animals are reduced,

it is expected that increased slaughter capacity in Canada will result in active bidding

between U.S. and Canadian packers for the available pool of live cattle. It is

possible that imports of live slaughter cattle may decline from historic proportions,

but the amount of change will depend on capacity utilization of Canadian and U.S

meat packers, exchange rates and transaction costs such as transportation and age

certification. Imports of feeder cattle will depend on forage conditions and grain

prices in the U.S. and Canada. It is likely that imports of beef will expand given

increased Canadian slaughter capacity. Import data does not permit an exact determination

of the form in which beef is imported. However, beef cuts fabricated in

Canada cannot receive a U.S. grade; thus imports of boxed beef and case ready beef

will likely be limited to those proportions which existed prior to the ban. Carcasses

and quarters may be transported in such a fashion as to permit their reassembly

into a carcass for the purposes of grading. Prior to the BSE discovery in Canada,

about 8 percent of imported beef from Canada entered the U.S. as carcasses, halves,

and quarters. Following the reopening of the border, beef imports were limited to

boneless beef, as a result there was has been no trade in carcasses. It is likely that

trade in carcasses will resume and proportion of cut imports may decline slightly.

23. Many packers have reported reductions in operations at beef plants.

Is this due to the inability to obtain Canadian cattle, to the Japanese ban,

or are there other reasons?

Response: There are varied reasons for reduced operations at some U.S. meat

packing plants during 2004 and 2005. Firms reducing operations have pointed to

weak consumer demand due to high beef prices, loss of export sales, difficulties in

obtaining slaughter cattle and poor operating margins. For example, one firm that

temporarily reduced operations in 5 plants in early 2005 raised concerns about tight

cattle supplies and attractive values in alternative meats given high retail beef

prices. The inability to obtain Canadian cattle is an important factor in reduced operations

because inability to access Canadian cattle has come at the same time the

cattle cycle has reached its low point. During 2004, 32.7 million head of cattle were

slaughtered in the United States, compared with 35.5 million during 2003. This 8-

percent decline reduced meat packers capacity utilization and drove up operating

costs. At the same time, farm-to-wholesale price spreads declined throughout 2004

putting additional pressure on plant profitability. While the opening of Asian markets

would increase demand for beef, and help some packers, the continued limitation

on the supply of available slaughter cattle would result in continued strong cattle

prices and pressure on price spreads. Another factor has been imports of beef

from Canada and elsewhere. As U.S. retail beef prices set record highs in 2005, U.S.

imports of beef rose, providing additional competitive pressure for U.S. meat packers.

Cow slaughter facilities, in particular, faced very limited availability of slaughter

cows, thus squeezing their profitability.

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24. The national animal ID plan now under development indicates that

it will be implemented for all farm species. If our major meat trade problem

is currently BSE-related, why not implement it more quickly for cattle?

Response: The National Animal Identification System will ultimately cover all

segments of production animal industries in the United States. Initially, the cattle

industry is our primary concern. We have implemented premises identification

which is a prerequisite for animal identification. The animal identification component

utilizing the new numbering system for individual animals will be implemented

mid year 2005. The cattle working group is well advanced in drafting identification

program standards, including the recommendation to utilize radio frequency

technology to automate the collection of animal identification movements. The plans

for the pork, sheep, and goat industries are also well along in development. Each

of these segments will be part of the initial phases of NAIS implementation.

25. If a national animal ID program were in place, how might that improve

prospects for reopening foreign markets to U.S. beef?

Response: The NAIS would allow for rapid tracing of animals in the event of an

outbreak, helping to limit the scope and expense of the outbreak and allowing us

to minimize impact on domestic and foreign markets. Additionally, the NAIS would

allow for the tracing of animals to specific regions, increasing the likelihood of opening

trade to those parts of the country that are not affected with highly infectious

diseases like foot-and-mouth disease (FMD).

26. Just four countries (Japan, Korea, Canada, and Mexico) have accounted

for most U.S. beef exports. What is USDA doing in the short term

(the next 3–6 months) to explore and exploit opportunities in other countries?

Response: Some 64 markets are currently accepting U.S. beef. Of those markets

still prohibiting U.S. beef exports, Japan, Korea, and Hong Kong represent over 90

percent of the export value based on 2003 exports. USDA is actively engaged in negotiations

with Hong Kong and prospects for resuming trade in this market within

the next three-to six months is high. In other secondary markets, Egypt and Taiwan

have both resumed imports of U.S. beef from cattle under 30 months of age. These

nations are setting an important example for their respective regions. We are also

engaging Russia and have submitted a proposal for resuming trade. Our agricultural

attaches and diplomats at U.S. Embassies around the world continue to engage

government officials at all levels as this administration remains committed to

resuming beef trade in all closed export markets.

27. Please describe the situation for U.S. beef exports in Asian markets

other than Japan, including Korea and Hong Kong and explain why Hong

Kong has agreed to accept Canadian but not U.S. beef?

Response: Taiwan opened its borders to U.S. beef on April 16, 2005 and the first

‘‘resumed’’ shipments arrived on April 24, 2005. On April 19–22 a USDA technical

team traveled to Korea for technical talks. There was a very positive exchange of

information and we agreed to host a Korean consumer group the week of May 9,

2005 and a technical team in early June. After these visits, we will engage Korea

in discussions on the terms and details of resuming U.S. exports. In Hong Kong,

after satisfying all of Hong Kong’s concerns regarding BSE mitigation measures,

and before the findings of the additional BSE cases, the Hong Kong government

(HKG) lifted its import ban on Canadian beef. Hong Kong has continued to express

concerns about U.S. capabilities to conduct animal trace backs in the event of another

BSE finding in the United States. The HKG is also questioning whether the

U.S. is making progress on a proposal to ban Specified Risk Materials (SRMs) from

all animal feed. The United States has provided considerable information to address

these concerns in a number of meetings and technical discussions. A Hong Kong

technical team is expected to visit the United States to see U.S. BSE control procedures.

We take this development as an indication that Hong Kong is close to making

a decision to lift the import ban on U.S. beef exports.

28. How exactly does USDA monitor Canadian compliance with U.S. import

requirements? For example, what specific assurances does USDA have

that these plants are properly segregating products? What changes in compliance

monitoring will occur when the border is further opened by the

January 4 final rule?

Response: FSIS monitors Canadian compliance with U.S. import requirements

through port-of-entry reinspections, as well as on-site system audits. While FSIS

has been assured by the Canadian government that it will comply with the U.S. im-

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port requirements, FSIS sends auditors to Canada on a regular basis to ensure that

our requirements for properly segregating products are being fully implemented and

enforced in those Canadian establishments certified to export to the United States.

FSIS has already conducted two audits - one in December 2004, and the other in

February 2005 - to focus on Canadian compliance with United States BSE food safety

requirements. These audits, combined with import reinspection, are the primary

means by which FSIS verifies compliance with U.S. food safety import requirements

and thereby protecting public health.

29. How many violations of the existing import rules has USDA found?

Have they been corrected? How many import permits have been rescinded

due to irregularities or violations?

Response: Since August of 2003 when USDA began allowing the importation of

boneless bovine meat from cattle under 30 months of age as well as certain other

ruminant products from Canada, compliance with permit conditions has been extremely

high. This has been due in large part to on-going communication and coordination

with Canadian agricultural officials who certify that all imports of approved

bovine products meet USDA guidelines. We have also worked closely with our counterparts

at the Department of Homeland Security to ensure that they are well informed

on all issues associated with Canadian imports. As such, we have only had

two issues that required some type of action either by Canadian agriculture officials

or USDA. We will remain vigilant in our efforts to ensure that only approved products

are allowed entry to the United States.

30. Recent newspaper articles have revealed that the Canadian Food Inspection

Agency (CFIA) found animal material in 66 of 110 feed ingredient

samples taken between January and March 2004. A CFIA official confirmed

that some of this material might have been ruminant protein. What efforts

did USDA take to evaluate the significance of these reports, and was this

evaluation taken into consideration in the January 4th rulemaking?

Response: Because of its close working relationship with Canada, USDA was

aware that CFIA had been considering animal feed testing as a potential part of

their feed ban compliance program. CFIA trained laboratory analysts to perform

this testing. These considerations led CFIA to implement a pilot project to test feed

during January, February, and March of 2004. Under this pilot project, CFIA inspectors

accepted feed samples—some from feed ingredients intended for use in ruminant

feed and some from finished ruminant feed products—and tested those samples

for the presence of animal protein. Instructions were to obtain approximately

half of the samples from domestic products and half from imports.

Officials found that multiple samples contained evidence of animal protein, but

the type of testing was not specific enough to identify the species of origin of such

protein. In other words, while the tests could identify animal protein they could not

determine whether or not the animal protein was prohibited material (like ruminant

meat-and-bone meal) or whether it was animal protein allowed under the feedban

(such as blood or porcine protein). Additional analysis and follow-up inspections at

firms where the sampled feed was produced had to be conducted to determine if the

feed actually contained prohibited material. These inspections found that only a

small percentage could have contained prohibited material, and CFIA and the producers

have taken corrective measure in these instances.

It should also be noted that the risk analysis never assumed 100 percent compliance

with the feed ban. Instead, it considered that the feed ban was effective overall.

As demonstrated in the Harvard risk analysis, which assumed a certain level

of non-compliance with the feed ban, even feed bans without 100 percent compliance

can effectively prevent or decrease the spread of BSE.

31. In late 2003, the United States and several other countries asked the

OIE to change the BSE risk categories. Please describe these changes and

their status within the OIE?

Response: During the fall of 2003, the OIE convened a group of experts to update

the Code Chapter on BSE. One of the group’s tasks was to examine ways to simplify

the Chapter by reducing the number of BSE risk categories from five to three. In

July of 2004, after obtaining input from member countries, the OIE presented for

consideration and comment two separate Code Chapters on BSE. One Chapter was

based on the existing Code, and included updated information while still retaining

the five BSE risk categories: free, provisionally free, minimal risk, moderate risk

and high risk. The other chapter was a proposal to simplify the number of risk categories

to three: negligible BSE risk without mitigating measures, negligible risk

with mitigating measures, and undetermined risk. Member countries commented on

these proposals, and, in January of 2005, the expert group convened again to evalu-

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ate comments. After this meeting, the OIE officially proposed moving from a 5-category

system to a 3-category system. Although the categories are simplified, the system

continues to focus on a risk-based approach for trading in bovine commodities.

These proposed changes are up for adoption at the upcoming OIE General Session

in May 2005.

32. What, specifically, has the Department done to rebuild the U.S.

public’s confidence in its BSE safeguards?

Response: We believe that effective communication with all stakeholders, especially

the public, has been key to ensuring confidence in the steps USDA has

taken—and will continue to take—with regard to BSE. In this regard, USDA officials

continue to inform the public and other groups through a variety of different

forums. We have held numerous teleconference briefings with the media, industry

representatives, and State officials to provide information and respond to specific

questions. In addition, USDA officials have attended countless meetings and conferences

across the country to meet with concerned groups and individuals and reinforce

our findings that the overall risk to human and animal health from BSE in

the United States is exceedingly minimal. There is also extensive information posted

on USDA’s website.

Through this communication, USDA has been able to explain the science behind

its policies. With the price and demand for U.S. beef remaining relatively steady,

it is evident that American consumers have received the message that BSE presents

an extremely low risk to public health.

33. In what way, if any, has the widespread criticism of USDA’s BSE actions

provided stronger arguments for those who believe some agency outside

of the Department of Agriculture ought to be responsible for meat

safety?

Response: The December 2003 discovery of a BSE-positive cow in Washington

State strengthened the partnership the Food Safety and Inspection Service (FSIS)

has with the Animal and Plant Health Inspection Service (APHIS). For instance,

under APHIS’ enhanced BSE surveillance program, FSIS collects samples from all

antemortem condemned cattle, except for veal calves not exhibiting central nervous

system symptoms, and provides the samples to APHIS for BSE testing. In addition,

senior level FSIS officials worked closely with their APHIS counterparts on the development

of the proposed minimal risk rule.

Moreover, FSIS has been and will continue to engage in substantive food safety

discussions with FDA and other agencies who share public health and food safety

responsibilities. Since 1999, FSIS and FDA have had a Memorandum of Understanding

(MOU) to exchange information on an on-going basis about establishments

that fall under both jurisdictions. FSIS and FDA will continue to work together to

ensure the safety of food products.

34. USDA continues to argue that its BSE protections have a sound basis

in science. If that is true, why is there still widespread public sentiment

that ‘‘mad cow’’ is a far more serious problem than USDA believes?

Response: As we mentioned, effective communication with all stakeholders, especially

the public, is key to ensuring confidence in the steps USDA has take—and

will continue to take—with regard to BSE. In this regard, USDA officials have set

out to inform the public and other groups through a variety of different forums.

Through this communication, USDA has been able to explain the science behind

its policies. American consumers have received the message that BSE presents an

extremely low risk to public health. It is worth noting that the price and demand

for U.S. beef has remained relatively steady.

35. Has USDA been successful in communicating the nature and level of

risk from BSE, relative to other food safety threats? Why or why not, and

what improvements are needed?

Response: Prior to the December 2003 discovery of a BSE-positive cow in Washington

State, USDA had in place a series of safeguards to protect the public health

from food safety threats, including those related to BSE. Upon discovery of the infected

animal, USDA published a notice and three interim final rules relating to

BSE which add a significant level of protection to an already robust food safety system.

The American public remains confident in the safety of the U.S. meat, poultry,

and egg supply, in part due to the many food safety accomplishments FSIS made

in 2004. In August of 2004, a Gallup poll found that more than 85 percent of Americans

are confident in the Federal Government’s ability to protect our food supply.

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36. What are the latest estimates on the economic impact of the ongoing

bans (in Japan and elsewhere) on U.S. beef and beef products? What have

been the impacts on: U.S. cattle producers; U.S. meat packers and processors;

and workers in the meat industry?

Response: USDA estimates that the value of lost beef and beef product exports

is $3.5–4.0 billion since the ban on U.S. exports was put into place. However, much

of that product was consumed domestically albeit at a lower price than would have

been expected had the U.S. been able to export freely. Had the U.S. been able to

export freely, it is likely cattle prices would have been $50-$70 per head higher generating

$1.7-$2.30 billion in increased cash receipts to producers. There are no formal

economic estimates of the losses to the meat packing industry. However, there

is anecdotal evidence that the bans have affected the sector. Swift and Tyson both

indicated that market closures, as well as the inability to source sufficient cattle,

were factors in reduced earnings. Several packers have reduced production at their

plants:

In October 2004, Swift cut second shift production 15 percent.

In late December 2004, Creekstone laid off 150 employees and reduced operations

to 4 days per week, due to the inability to ship to Japan. Majority interest in

Creekstone was sold in early March. The new owners have indicated that they

would plan to expand production.

In early January 2005, Tyson announced that it was temporarily suspending operations

at 4 plants and cutting a shift at a 5th plant. Tyson announced that operations

would resume in February.

In early January 2005, National Beef cut production. Production had previously

been cut in November but later restored.

In early March 2005, Swift & Company announced a 20-percent reduction in production

at a Nebraska plant. They cited high cattle prices

In early March 2005, Cargill Meat Solutions announced additional cuts in production

at 7 plants located in Texas, Kansas, Nebraska, Colorado, Wisconsin, and Pennsylvania.

High cattle prices and tight supplies were cited as reasons for reductions.

37. Tyson recently reported that it was reducing operations at four beef

plants. Was this due primarily to the inability to obtain Canadian cattle, to

the Japanese ban, or to other reasons?

Response: Tyson Foods is the best source for understanding their motives for reducing

plant operations. Tyson’s temporarily suspended operations on January 10

at plants in Denison, Iowa; Norfolk and West Point, Nebraska; and Boise, Idaho.

Second-shift processing at Pasco, Washington, was also suspended. The reduced operations

were attributed to ‘‘unfavorable beef operating margins’’ (Tyson press release,

January 6, 2005). John Tyson, chairman and CEO of Tyson Foods, indicated,

‘‘This is a difficult decision, however, we believe it’s the right thing for us to do at

this time, especially given the challenging market conditions and unfavorable operating

margins our beef business continues to face. Our plants have been running

at less than 75 percent of capacity over the past 2 months, which is 10 to 15 percent

below historical levels.’’

On February 10, 2005, Tyson announced a schedule to resume operations at the

plants. At that time, John Tyson said in a statement, ‘‘While cattle numbers remain

tight, we believe supplies will improve in the months ahead, especially as the anticipated

flow of Canadian cattle resumes. Beef demand has been weak, largely because

of high beef prices and the attractive value of competing meats. We typically experience

seasonal improvements in beef sales as we move into the spring and summer

months. We’re hopeful cattle prices will moderate, so beef can be priced more competitively

with other proteins’’ (Tyson press release, February 10, 2005).

38. There have been conflicting reports about when U.S. beef exports to

Japan will begin again. What is your best assessment of a start-up date?

Response: It is difficult to provide a specific date on when U.S. beef exports will

begin. President Bush has talked to Prime Minister Koizumi, who said he wants to

resume beef trade as soon as possible, but refrained from offering a timetable.

USDA has been frustrated by the slow progress made by Japan in opening its market

to U.S. beef. Nevertheless, reestablishing trade with Japan remains this administrations

top priority. In fact, Secretaries Rice and Mineta recently raised the issue

with their counterparts on separate occasions while visiting Japan. In addition, on

April 25–28, 2005 Dr. Charles Lambert, Deputy Under Secretary for Regulatory and

Marketing Programs, led a team of USDA officials and academic experts to Japan

for technical discussions and to participate in a number of public diplomacy activities

aimed at educating Japanese media and consumer groups about the safety of

U.S. beef. Dr. Lambert had very positive discussions with Japanese government offi-

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cials and to encourage more rapid progress, we agreed to host a technical team from

Japan in early May to review our BSE control procedures.

39. Please describe exactly what conditions must be satisfied in order for

U.S. beef to begin entering Japan.

Response: Japan’s Food Safety Commission submitted its report to Japanese government

officials recommending an exemption of BSE testing from animals under

21 months of age. The decision to exempt these animals from BSE testing is expected

to become final soon now that the 30-day comment period has passed. With

the testing decision to be finalized, Japan must also prepare for rulemaking on imports.

We have submitted a series of responses to questions the Ministries of Agriculture

(MAFF) and Health (MHLW) had as they prepare for deliberations by the

Food Safety Commission regarding imports of U.S. beef. In addition, a team of Japanese

technical experts will visit the United States on May 9, 2005 to verify U.S.

BSE control measures. After the site visit, MAFF and MHLW will hold a series of

public hearings in Japan before a final decision to lift the import ban is made.

USDA will also need to finalize a beef export verification program for U.S. packers

to certify that Japan’s import requirements are being met.

40. How, specifically, will USDA ensure that Canadian beef from cattle

over 20 months is not co-mingled with beef destined for Japan? What procedures

will be in place to monitor Canadian products and ensure that all

import requirements are being met?

Response: Once an agreement is finalized with Japan, the Agricultural Marketing

Service (AMS) will develop a Beef Export Verification program to ensure the terms

of the agreement, such as age and country of origin, are met. In fact, a BEV program

addressing the commingling issue was developed for Japan to accept U.S. beef

after the first case of BSE was found in Canada in May 2003. The Food Safety Inspection

Service will take AMS’s verification and certify on a U.S. export health certificate

compliance with Japan’s import requirements. USDA officials assigned to

the packing plants will have oversight responsibilities to ensure all requirements

are being met.

41. USDA states that its Beef Export Verification Program will be used

to ensure that beef to Japan is from cattle 20 months and younger. Is USDA

willing to consider a program of this type for small beef packers who also

want to satisfy the same Japanese market by testing all cattle? Why or why

not?

Response: Some small packers have expressed an interest in testing all cattle presented

for slaughter for BSE as a means of assuring consumers and trading partners

of food safety. Because of the nature of the disease, the earliest point at which

current testing methods can detect a positive case of BSE is 2 to 3 months before

the animal begins to demonstrate clinical signs. The incubation period for this disease—

the time between initial infection and the manifestation of clinical signs—is

generally very long, on average about 5 years. As a result, there is a long period

during which testing an infected animal with the current methodology would not be

able to detect the disease and therefore testing would not be effective. This is especially

likely if the animal is both young and clinically normal at the time samples

are obtained for testing. Most cattle that go to slaughter in the United States are

both young and clinically normal. Accordingly, a testing program that tested all

slaughter cattle would have negligible benefit from a public health standpoint.

In particular, it is the removal of specified risk materials from the human food

chain, along with the other safeguarding measures administered by USDA, that provide

assurances of food safety. We are confident that these measures address potential

public and animal health risks concerning BSE.

42. There appears to be continuing opposition among Japanese consumers

to any U.S. beef imports. Why have USDA and the beef industry been

unable to convince the Japanese public that U.S. beef is safe?

Response: Japanese consumers lost confidence in the safety of beef after Japan’s

first BSE finding. Beef demand declined resulting in a reduction in imports. Largely

due to U.S. Meat Export Federation (USMEF) and USDA consumer-education programs

and marketing efforts, Japanese consumer’s confidence in imported U.S. beef

began to rise resulting in increased imports until Japan banned U.S. beef imports

in December 2003. FAS/Tokyo and USMEF have produced a joint plan to again address

consumer confidence and we are confident that Japanese consumers will return

to demanding U.S. beef.

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43. What is your assessment of the Japanese view of the January 4th Canada

border rule? For example, is it a help or a hindrance in the negotiations

with them?

Response: The Minimal Risk Rule was an example to the rest of the world how

the United States relied upon science to set BSE import policy. While the Japanese

government has asked a number of questions regarding the minimal risk rule and

the subsequent court injunction, and Senate resolution to stop implementation of

the rule, there have been no indications by Japan that the rule or the court injunction

have negatively affected negotiations.

44. USDA’s Foreign Agricultural Service has reported that lost U.S. beef

sales to Japan have been replaced by beef from other countries like Australia,

and also by substitutes like pork and chicken. What specific actions

have USDA and the industry discussed to win back the Japanese market

for beef?

Response: The Japanese government has asked that USDA implement a risk communications

plan to help ensure public acceptance of any agreement between the

U.S. and Japan on BSE. In response, the FAS office in Tokyo and the U.S. Meat

Export Federation (USMEF) have jointly produced a pre- and post-market opening

plan that focuses on the potential concerns and misperceptions about BSE to consumers,

the media and political officials. Some examples of activities being planned

or already being implemented are editorials, offering trips to the United States for

journalists, seminars on BSE, and the dissemination of technical materials.

45–46. It is my understanding that Canadian animals imported to the

United States will have their Canadian Animal Identification numbers listed

on the health certificate that accompanies their lot. I also understand

that within the year all Canadian cattle will be marked with RFID tags. In

states like New York, where an US-based RFID system is already operational,

all that information from the Canadian RFID tag will presumably

be directly accessible to U.S. authorities. What efforts are underway to capture

that valuable information in other border states that may lack their

own RFID program? How soon will the capacity be in place to interface nation-

wide with this Canadian information on cattle entering from any port?

Response: (Questions 45–46) Under the final rule, 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. There will be a health certificate

for each shipment of animals; the number on the eartag will be listed on

the health certificate. This health certificate will accompany the animals as they

move to the feedlot and/or to slaughter. This certificate, with the record of specific

individual identification, will allow us sufficient information to communicate with

our Canadian colleagues as necessary to access their records for tracebacks. Specifically

in reference to BSE, it is important to note that since this is not a highly contagious

disease, some of the time constraints in rapid traceback are not as critical.

USDA has relied on a long history of communication and cooperation with CFIA.

This cooperation has been evident in past animal disease investigations as

tracebacks occur back and forth across our border. We anticipate that this collaboration

will continue in the future.

47. Canada already has a mandatory animal ID system in place. Why has

our animal ID system been delayed for 3 years when the pilot project FAIR

is working?

Response: The growing number of animal disease outbreaks around the world, the

threat of intentional introductions of foreign animal diseases, and the single detection

of BSE in the United States in December 2003 has made the development of

a National Animal Identification System (NAIS) a top USDA priority. USDA is currently

working on the first phase of implementation, which entails identifying and

registering premises that house animals. Such premises would include locations

where livestock and poultry are managed, marketed, or exhibited. APHIS has provided

a Standardized Premises Registration System—or SPRS—to States that requested

it. In addition, several other States are using compliant premises registration

systems administered by a State and/or through a third party. APHIS will support

the interface of all compliant systems with the premises number allocator and

premises information repository. The goal is to have all States operational for premises

registration by mid-year 2005.

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In mid–2005, USDA plans to implement the animal identification number (AIN)

management system to administer the assignment of AINs to tag manufacturers

and to record the distribution of the animal numbers to a producer’s premises. Individual

animal identification and tracking animal movements can then be implemented.

48. If a national animal ID program were in place, how might that improve

prospects for reopening foreign markets to U.S. beef?

Response: The NAIS would allow for rapid tracing of animals in the event of an

outbreak, helping to limit the scope and expense of the outbreak and allowing us

to minimize impact on domestic and foreign markets. Additionally, the NAIS would

allow for the tracing of animals to specific regions, increasing the likelihood of opening

trade to those parts of the country that are not affected.

49. The board of the National Cattlemen’s Beef Association recently proposed

a national ID system which differs from that being developed by

USDA. Can you describe the differences and provide your view on whether

these differences will delay implementation of a program?

Response: NCBA has proposed a private animal ID system. USDA is receptive to

reviewing solutions offered by private entities, but only if we can be assured that

they will provide the same level of data access and completeness that our own system

will be capable of, within the timeframes we are considering.

50. When do you believe a national ID program will be in place?

Response: USDA is currently working on the first phase of implementation, which

entails identifying and registering premises that house animals. Such premises

would include locations where livestock and poultry are managed, marketed, or exhibited.

APHIS has provided a Standardized Premises Registration System—or

SPRS—to States that requested it. In addition, several other States are using compliant

premises registration systems administered by a State and/or through a third

party. APHIS will support the interface of all compliant systems with the premises

number allocator and premises information repository. The goal is to have all States

operational for premises registration by mid-year 2005.

In mid–2005, USDA plans to implement the animal identification number (AIN)

management system to administer the assignment of AINs to tag manufacturers

and to record the distribution of the animal numbers to a producer’s premises. Individual

animal identification and tracking animal movements could be implemented

afterwards.

51. I am concerned that that feeder cattle and calf supplies outside

feedlots in Canada are currently at record levels and nearly double what

they were in 2002, a high-water mark year in terms of feeder and fed cattle

imports from Canada. What efforts has USDA made to identify and implement

legal means to gradually resume trade with Canada so we can prevent

a shock to the U.S. cattle marketplace and mitigate the very real potential

for short-term economic harm to U.S. beef cattle producers?

Response: USDA’s risk assessment focused on the risk that opening the Canadian

border to specific animals and products would pose to animal and human health and

determined it to be of minimal risk. The major trade impact of the BSE minimal

risk rule when it goes into effect will be a resumption of imports of live cattle under

30 months old from Canada. On February 22, 2005, the Department released a revised

forecast that 1.3 million head of Canadian cattle would enter the U.S. in 2005,

had the rule gone into effect on March 7, 2005. Such imports result from a buildup

of cattle in Canada, lower cattle prices in Canada than in the U.S. and the reduced

availability of U.S. cattle for U.S. meat packers. The increase in cattle outside

of feedlots in Canada would also be a key source of U.S. imports. As a result of the

imports, U.S. meat packers would be able to increase capacity utilization and reduce

operating costs.

The number of live cattle expected to be imported compares with 2004 U.S.

slaughter of 32.7 million head. In addition, in the 5 years prior to the finding of

BSE in Canada, the U.S. imported an average of 1.25 million head annually from

Canada, with 1.7 million head in 2002. So, the 1.3 million head of Canadian cattle

imports is about what was typically imported prior to the finding of BSE in Canada.

USDA estimates a 2.6-percent decline in fed cattle prices as a result of the live cattle

imports but that decline is compared with no trade. Of course, no trade is abnormal.

In addition, much of the price effect is already reflected in cattle futures market

prices. Moreover, the negative effects on cattle prices will likely be at least partially

offset by long-term gains resulting from expanded world trade.

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The estimate of cattle imports is uncertain and there are a number of factors that

could mitigate the flow of cattle from Canada. (1) the price spread between U.S. and

Canadian cattle had been narrowing, particularly in late February and early March;

(2) pasture and range conditions in Canada are good, which could cause producers

to keep cattle on pastures; (3) the value the U.S. dollar has been depreciating

against the Canadian dollar, thus increasing cattle producer returns in Canada

above the levels indicated by U.S. dollar prices; (4) Canadian meat packers have

stepped up their own buying, as evidenced in slaughter year-to-date in 2005, which

is up 11 percent in Canada; and (5) logistical problems such as limited transportation

and higher costs due to the import regulations will increase import costs.

These five factors will act together as a disincentive to import.

52. Secretary Johanns, you recently stated that it was ‘‘not scientifically

consistent’’ to allow meat from older Canadian cattle—but not the cattle

themselves—to enter the United States. Why then did USDA regulators initially

decide to include meat from older cattle in the January 4 rule? What

did your expert panels recommend with regard to this aspect of the rule?

Response: In the extension to the comment period published in April 2004, USDA

proposed allowing the importation of beef from Canada, regardless of the age of the

cattle from which it was derived, provided other specified mitigating conditions were

met, and invited comment on this change. The risk analyses support the conclusion

that certain tissues’specified risk materials, or SRMs—are considered at particular

risk of containing the BSE agent in infected animals and therefore should be prohibited

from import. The SRMs can be safely excluded from meat and other products,

therefore these could be imported from animals of any age.

In February, however, Secretary Johanns announced a delay in the effective date

for allowing imports of meat from animals 30 months of age and over. This delay

was appropriate given that the ongoing investigations into finds of BSE in Canada

in older animals were not complete at that time. The delay also addressed public

comments that this part of the final rule does not reflect the evidence that beef from

animals 30 months and over processed in Canada has the same risk profile as beef

from Canadian animals 30 months and over processed in the United States. To address

these concerns, Secretary Johanns directed USDA officials to develop a plan

to allow imports of animals 30 months and older for slaughter as well as beef from

over 30-month animals in resuming full trade with Canada.Neither the International

BSE Review Team nor the Secretary’s Advisory Committee on Foreign Animal

and Poultry Diseases provided USDA with an assessment of the risk levels associated

with imported animals or animal products. Rather, these groups assessed

domestic mitigations against BSE, including enhanced surveillance and SRM removal.

53–54. When it announced the final rule to permit entry of Canadian cattle,

USDA stated: ‘‘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.’’ (Emphasis added.)How does this assurance

that the ban is ‘‘effectively enforced’’ square with the fact that the last BSE

cow was born after this ban? If the recent USDA report is true and ‘‘the

Canadian feed ban is not substantially different than the U.S. feed ban,’’

how come the score is 4 to 0?

Response: (Questions 53–54) The cases identified in Canada reflect exposure that

happened either prior to the feed ban was implemented or shortly thereafter. Continued

surveillance within Canada, specifically the lack of positive cases identified

in animals born quite some time after the implementation of the feed ban and the

lack of cases outside of a limited geographic area, contributes to the possibility that

the disease exposure was isolated and clustered. They also confirm the evidence that

the disease is not continuing to circulate within Canada, primarily because an effective

feed ban is in place. While further investigations may eventually identify the

original source of introduction of the agent into Canada, it is also likely that they

will not be able to pinpoint specifics that happened many years ago.

The feed ban in Canada was initially implemented in August 1997, with certain

actions grandfathered until October 1997. The last case, identified on January 11,

2005, was born approximately 6 months after the full implementation. As mentioned

previously, a complex feed ban that requires restructuring of various operations cannot

be implemented instantly. As the necessary changes were being developed and

implemented, it is possible that some ruminant feed produced shortly after the feed

ban became contaminated with prohibited materials. In addition, it is also possible

that feed manufactured prior to the feed ban was still in use.

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On February 25, USDA released the final report of the feed ban technical team.

Overall, the technical team found that Canada has a robust feed ban inspection program,

that overall compliance with the feed ban is good, and that the feed ban is

reducing the risk of transmission of BSE in the Canadian cattle population. The information

provided by the U.S. team verifies the information cited in the risk analysis

of the rule, and supports the conclusion in the risk analysis that the feed ban

is effective.

55–56. Until January, U.S. and Canadian authorities had asserted many

times that the feed ban in Canada became effective in August 1997. However,

a BSE cow was born after the ban. Since then, the USDA now admits

in a report that the feed ban was allowed a phase-in period. Would it be

accurate to say that the feed ban did not take place in August 1997, but instead

took place whenever the feed supplies in the market were exhausted?

And if so, why were Congress and the American public kept in the dark?

Response: (Questions 55–56) The proposed rule, final rule, and supporting risk

analyses state that the feed ban in Canada was implemented in August 1997. They

also provide general information about what Canada’s feed regulations include, and

some detail about compliance efforts and activities. The overall conclusion in the

risk analyses has been that the feed ban is effective.

The feed ban in Canada was initially implemented in August 1997, with certain

actions grandfathered until October 1997. Achieving full compliance with a feed ban

inevitably takes time, due to complexities of the regulations and the industries involved.

Because of these complexities and the requirement that various operations

of feed companies be restructured, a feed ban cannot be implemented with 100 percent

compliance instantly.

International authorities generally recognize that it may take 6 months or longer

to completely clear out any remaining feed from the old system after a feed ban is

implemented; USDA and Canadian officials believe that feed manufacturers abruptly

discontinued formulating ruminant

snip...

http://agriculture.house.gov/hearings/109/1091.pdf

Audit Report

Animal and Plant Health Inspection Service

Bovine Spongiform Encephalopathy (BSE) Surveillance Program – Phase II

and

Food Safety and Inspection Service

Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products - Phase III

Report No. 50601-10-KC January 2006

Finding 2 Inherent Challenges in Identifying and Testing High-Risk Cattle Still Remain

Our prior report identified a number of inherent problems in identifying and testing high-risk cattle. We reported that the challenges in identifying the universe of high-risk cattle, as well as the need to design procedures to obtain an appropriate representation of samples, was critical to the success of the BSE surveillance program. The surveillance program was designed to target nonambulatory cattle, cattle showing signs of CNS disease (including cattle testing negative for rabies), cattle showing signs not inconsistent with BSE, and dead cattle. Although APHIS designed procedures to ensure FSIS condemned cattle were sampled and made a concerted effort for outreach to obtain targeted samples, industry practices not considered in the design of the surveillance program reduced assurance that targeted animals were tested for BSE.

In our prior report, we recommended that APHIS work with public health and State diagnostic laboratories to develop and test rabies-negative samples for BSE. This target group is important for determining the prevalence of BSE in the United States because rabies cases exhibit clinical signs not inconsistent with BSE; a negative rabies test means the cause of the clinical signs has not been diagnosed.

APHIS agreed with our recommendation and initiated an outreach program with the American Association of Veterinary Laboratory Diagnosticians, as well as State laboratories. APHIS also agreed to do ongoing monitoring to ensure samples were obtained from this target population.

Although APHIS increased the samples tested from this target group as compared to prior years, we found that conflicting APHIS instructions on the ages of cattle to test resulted in inconsistencies in what samples were submitted for BSE testing. Therefore, some laboratories did not refer their rabies negative samples to APHIS in order to maximize the number tested for this critical target population. In addition, APHIS did not monitor the number of submissions of rabies negative samples for BSE testing from specific laboratories.

According to the Procedure Manual for BSE Surveillance, dated October 2004, the target population includes:

Central nervous system (CNS) signs and/or rabies negative - sample animals of any age (emphasis added):

a. Diagnostic laboratories –samples submitted due to evidence of CNS clinical signs.

Rabies Negative Samples

USDA/OIG-A/50601-10-KC Page 19 USDA/OIG-A/50601-10-KC Page 20

b. Public health laboratories – rabies negative cases.

c. Slaughter facilities – CNS ante mortem condemned at slaughter, sampled by FSIS.

d. On-the-farm – CNS cattle that do not meet the criteria for a foreign animal disease investigation.

For FYs 2002, 2003, and 2004 (through February 2004), NVSL received 170, 133, and 45 rabies-negative samples, respectively. Between June 1, 2004, and May 29, 2005, the number of samples received for testing increased to 226 rabies suspect samples. The collection sites submitting these samples follow.

Number of Rabies
Suspect Submissions *

Slaughter Plant
0

Renderer
2

On-Farm
11

Public Health Lab
94

Diagnostic Lab
81

3D-4D
8

Other
4

Collection Site

Total

200

* 26 were tested but not counted by APHIS towards meeting the target goals because the obex was not submitted.

We obtained a copy of a memorandum, dated July 13, 2004, that APHIS sent to diagnostic and public health laboratories providing them instructions on submitting samples for cattle showing signs of CNS diseases, but testing negative for rabies. The letter was sent to about 170 State veterinary diagnostic and public health laboratories and discussed the need to submit specimens to NVSL of all adult cattle (emphasis added) that showed signs of CNS diseases, but tested negative for rabies. This directive did not specify the age of the cattle. The Procedure Manual for BSE Surveillance, dated October 2004, specified samples of cattle of any age should be submitted.

We contacted laboratories in six States to determine if it was standard procedure to submit all negative rabies samples to NVSL. We found that, because of the lack of specificity in the APHIS letter and inadequate followup by APHIS, there were inconsistencies in the age of cattle samples submitted for BSE testing. For those States contacted, the following samples were submitted versus tested as negative for rabies.

USDA/OIG-A/50601-10-KC Page 21

Rabies Negative Tests Not Sent for BSE Testing Since June 1, 2004
State
Negative Rabies Tests

Not Sent for BSE Testing
Pennsylvania a/

15
18
Kansas b/

69
16
Wisconsin c/

1
11
South Dakota d/

0
7
Arizona e/

5
0
Mississippi e/

4
0
Total

Sent for BSE Testing

33

85

12

7

5

4

146

94

52

a/ A Pennsylvania laboratory official said only rabies negative cattle over 20 months of age were submitted for BSE testing. The laboratory did not submit 18 samples for BSE testing because the animals were less than 20 months of age.

b/ Kansas laboratory officials said early in the expanded surveillance program, there was confusion as to the cattle ages that should be submitted for BSE testing. They did not know if cattle should be submitted that were above 20 months or 30 months of age. Of the 16 animals not submitted for BSE testing, 14 were under 20 months of age from early in the expanded surveillance program. The other two animals were not tested due to internal laboratory issues. The Kansas and Nebraska area office officials contacted the laboratory and told the officials to submit rabies negative cattle of any age for BSE testing. The laboratory now submits all rabies negative cattle for BSE testing.

c/ A Wisconsin laboratory official said only rabies negative cattle samples 30 months of age or older are submitted for BSE testing. Of the 11 animals not submitted for BSE testing, 8 were less than 30 months of age. Wisconsin laboratory officials were not certain why the other three samples were not submitted.

d/ Laboratory officials from South Dakota said they did not receive notification from APHIS regarding the submission of rabies negative cases for BSE testing. The section supervisor and laboratory director were not aware of any letter sent to the laboratory. The section supervisor said most bovine rabies tests at the laboratory are performed on calves. We confirmed the laboratory’s address matched the address on APHIS’ letter distribution list. However, there was no evidence that the South Dakota area office contacted the laboratory. The laboratory was not listed on the documentation from the APHIS regional office detailing the area office contacts with laboratory personnel. We contacted the South Dakota area office and were advised that while some contact had been made with the laboratory, the contact may have involved Brucellosis rather than BSE. On May 4, 2005, the area office

33 Report from the Secretary’s Advisory Committee on Foreign Animal and Poultry Diseases, February 13, 2004.

advised us they recently contacted the laboratory regarding the submission of rabies negative samples for BSE testing.

e/ Arizona and Mississippi laboratory officials said they submitted all rabies negative samples for BSE testing regardless of the age of the animal.

An NVSL official stated that APHIS is not concerned with rabies negatives samples from cattle less than 30 months of age. This position, however, is contrary to APHIS’ published target population.

Our prior audit recognized the significant challenge for APHIS to obtain samples from some high-risk populations because of the inherent problems with obtaining voluntary compliance and transporting the carcasses for testing. USDA issued rules to prohibit nonambulatory animals (downers) from entering the food supply at inspected slaughterhouses. OIG recommended, and the International Review Subcommittee33 emphasized, that USDA should take additional steps to assure that facilitated pathways exist for dead and nonambulatory cattle to allow for the collection of samples and proper disposal of carcasses. Between June 1, 2004, and May 31, 2005, the APHIS database documents 27,617 samples were collected showing a reason for submission of nonambulatory and 325,225 samples were collected with reason of submission showing "dead."

APHIS made extensive outreach efforts to notify producers and private veterinarians of the need to submit and have tested animals from these target groups. They also entered into financial arrangements with 123 renderers and other collection sites to reimburse them for costs associated with storing, transporting, and collecting samples. However, as shown in exhibit F, APHIS was not always successful in establishing agreements with non-slaughter collection sites in some States. APHIS stated that agreements do not necessarily reflect the entire universe of collection sites and that the presentation in exhibit F was incomplete because there were many collection sites without a payment involved or without a formal agreement. We note that over 90 percent of the samples collected were obtained from the 123 collection sites with agreements and; therefore, we believe agreements offer the best source to increase targeted samples in underrepresented areas.

We found that APHIS did not consider industry practices in the design of its surveillance effort to provide reasonable assurance that cattle exhibiting possible clinical signs consistent with BSE were tested. Slaughter facilities do not always accept all cattle arriving for slaughter because of their business requirements. We found that, in one State visited, slaughter facilities pre-screened and rejected cattle (sick/down/dead/others not meeting business

Downers and Cattle that Died on the Farm

USDA/OIG-A/50601-10-KC Page 22 USDA/OIG-A/50601-10-KC Page 23

34 FSIS regulations do not specifically address the designation of an establishment’s "official" boundaries; however, FSIS Notices 29-04 (dated May 27, 2004) and 40-04 (dated July 29, 2004) make it clear that FSIS inspection staff are not responsible for sampling dead cattle that are not part of the "official" premises.

35 APHIS’ area office personnel stated that it was their understanding that some establishments in the State were not presenting cattle that died or were down on the transport vehicle to FSIS for ante mortem inspection. The dead and down cattle were left in the vehicle, if possible. In rare circumstances, dead cattle may be removed from the trailer by plant personnel to facilitate the unloading of other animals.

36 A May 20, 2004, Memorandum between the Administrators of APHIS and FSIS.

standards) before presentation for slaughter in areas immediately adjacent or contiguous to the official slaughter establishment. These animals were not inspected and/or observed by either FSIS or APHIS officials located at the slaughter facilities.

FSIS procedures state that they have no authority to inspect cattle not presented for slaughter. Further, APHIS officials stated they did not believe that they had the authority to go into these sorting and/or screening areas and require that the rejected animals be provided to APHIS for BSE sampling. Neither APHIS nor FSIS had any process to assure that animals left on transport vehicles and/or rejected for slaughter arrived at a collection site for BSE testing. FSIS allows slaughter facilities to designate the area of their establishment where federal inspection is performed; this is designated as the official slaughter establishment.34

We observed animals that were down or dead in pens outside the official premises that were to be picked up by renderers. Animals that were rejected by plant personnel were transported off the premises on the same vehicles that brought them to the plant.35

A policy statement36 regarding BSE sampling of condemned cattle at slaughter plants provided that effective June 1, 2004, FSIS would collect BSE samples for testing: 1) from all cattle regardless of age condemned by FSIS upon ante mortem inspection for CNS impairment, and 2) from all cattle, with the exception of veal calves, condemned by FSIS upon ante mortem inspection for any other reason.

FSIS Notice 28-04, dated May 20, 2004, informed FSIS personnel that, "FSIS will be collecting brain samples from cattle at federally-inspected establishments for the purpose of BSE testing." The notice further states that, "Cattle off-loaded from the transport vehicle onto the premises of the federally-inspected establishment (emphasis added), whether dead or alive, will be sampled by the FSIS Public Health Veterinarian (PHV) for BSE after the cattle have been condemned during ante mortem inspection. In addition, cattle passing ante mortem inspection but later found dead prior to slaughter will be condemned and be sampled by the FSIS PHV."

USDA/OIG-A/50601-10-KC Page 24

37 FSIS Notice 40-04, dated July 29, 2004.

38 FSIS Notice 29-04, dated May 27, 2004.

APHIS has the responsibility for sampling dead cattle off-loaded onto plant-owned property that is adjoining to, but not considered part of, the "official premises.37 FSIS procedures38 provide that "Dead cattle that are off-loaded to facilitate the off-loading of live animals, but that will be re-loaded onto the transport vehicle, are not subject to sampling by FSIS.

While performing our review in one State, we reviewed the circumstances at two slaughter facilities in the State that inspected and rejected unsuitable cattle before the animals entered the official receiving areas of the plants. This pre-screening activity was conducted in areas not designated by the facility as official premises of the establishment and not under the review or supervision of FSIS inspectors. The plant rejected all nonambulatory and dead/dying/sick animals delivered to the establishment. Plant personnel refused to offload any dead or downer animals to facilitate the offloading of ambulatory animals. Plant personnel said that the driver was responsible for ensuring nonambulatory animals were humanely euthanized and disposing of the carcasses of the dead animals. Plant personnel informed us that they did not want to jeopardize contracts with business partners by allowing unsuitable animals on their slaughter premises.

In the second case, one family member owned a slaughter facility while another operated a livestock sale barn adjacent to the slaughter facility. The slaughter facility was under FSIS’ supervision while the sale barn was not. Cattle sometimes arrived at the sale barn that were sick/down/dead or would die or go down while at the sale barn. According to personnel at the sale barn, these animals were left for the renderer to collect. The healthy ambulatory animals that remained were marketed to many buyers including the adjacent slaughter facility. When the slaughter facility was ready to accept the ambulatory animals for processing, the cattle would be moved from the sale barn to the slaughter facility where they were subject to FSIS’ inspection.

We requested the slaughter facilities to estimate the number of cattle rejected on a daily basis (there were no records to confirm the estimates). We visited a renderer in the area and found that the renderer had a contract with APHIS to collect samples for BSE testing. In this case, although we could not obtain assurance that all rejected cattle were sampled, the renderer processed a significant number of animals, as compared to the slaughter plants’ estimates of those rejected. Due to the close proximity (less than 5 miles) of the renderer to the slaughter facilities, and the premium it paid for dead cattle that were in good condition, there was a financial incentive for transport drivers to dispose of their dead animals at this renderer.

USDA/OIG-A/50601-10-KC Page 25

In our discussions with APHIS officials in Wisconsin and Iowa, they confirmed that there were plants in their States that also used pre-screening practices. On May 27, 2005, we requested APHIS and FSIS to provide a list of all slaughter facilities that pre-screened cattle for slaughter in locations away from the area designated as the official slaughter facility. Along with this request, we asked for information to demonstrate that either APHIS or FSIS confirmed there was a high likelihood that high-risk animals were sampled at other collection sites.

In response to our request, the APHIS BSE Program Manager stated that APHIS did not have information on slaughter plants that pre-screen or screen their animals for slaughter suitability off their official plant premises. To their knowledge, every company or producer that submits animals for slaughter pre-sorts or screens them for suitability at various locations away from the slaughter facility. For this reason, USDA focused its BSE sample collection efforts at other types of facilities such as renderers, pet food companies, landfills, and dead stock haulers. Further, in a letter to OIG on June 14, 2005, the administrators of APHIS and FSIS noted the following:

"…we believe that no specific actions are necessary or appropriate to obtain reasonable assurance that animals not presented for slaughter are being tested for BSE. There are several reasons for our position. First, we do not believe that the practice is in fact causing us to not test a significant enough number of animals in our enhanced surveillance program to invalidate the overall results. Second, OIG has concluded that because of the geographical proximity and business relationships of the various entities involved in the case investigated, there is reasonable assurance that a majority of the rejected cattle had been sampled. Third, it is also important to remember that the goal of the enhanced surveillance program is to test a sufficient number of animals to allow us to draw conclusions about the level of BSE (if any) in the American herd…We believe that the number we may be not testing because of the "pre-sorting" practice does not rise to a significant level. The number of animals tested to date has far exceeded expectations, so it is reasonable to infer that there are few of the animals in question, or that we are testing them at some other point in the process…APHIS estimated…there were approximately 446,000 high risk cattle…[and APHIS has]…tested over 375,000 animals in less than 1 year. This indicated that we are missing few animals in the high-risk population, including those that might be pre-sorted before entering a slaughter facility’s property."

We obtained 123 APHIS sampling agreements and contracts with firms and plotted their locations within the United States (see exhibit F). We also analyzed the samples tested to the BSE sampling goals allocated to each State under the prior surveillance program. This analysis showed that there are

USDA/OIG-A/50601-10-KC Page 26

39APHIS noted that sites with agreements do not necessarily reflect the entire universe of collection sites and at some sites APHIS collects samples with no payment involved and no agreement in place. OIG agrees that not all collection sites are reflected in our presentation of the 123 sites with reimbursable agreements. OIG believes obtaining sampling agreements is one of the primary methods available to increase sample numbers in areas with sampling gaps.

sampling gaps in two large areas of the United States where APHIS did not have contracts with collection sites. These two areas are shown in the following chart (Montana, South Dakota, North Dakota and Wyoming – Group 1 and Louisiana, Oklahoma, Arkansas, and Tennessee – Group 2):
State

Original Sampling Goal Based on (268,500 sampling goal)

Samples collected as of May 31, 2005

No. of BSE Sampling Agreements/
Contracts39
MT
5,076

4,894
2
SD
6,938

4,146
1
ND
3,616

3,442
0
WY
2,513

2,452
0
AREA TOTAL

14,934
OK
7,792

5,385
1
AR
3,672

3,319
0
TN
4,938

1,888
1
LA
2,312

1,860
1
AREA TOTAL

Deficit

182

2,792

174

61

2,407

353

3,050

452

12,452

APHIS notes that for the current surveillance program, it had established regional goals and APHIS was not trying to meet particular sampling levels in particular States. However, we believe that it would be advantageous for APHIS to monitor collection data and increase outreach when large geographical areas such as the above States do not provide samples in proportion to the numbers and types of cattle in the population.

We also disagree with APHIS/FSIS’ contention that because they have tested over 375,000 of their 446,000 estimate of high risk cattle, few in the high-risk population are being missed, including those that might be pre-screened before entering a slaughter facility’s property. In our prior audit, we reported that APHIS underestimated the high-risk population; we found that this estimate should have been closer to 1 million animals (see Finding 1). We recognize that BSE samples are provided on a voluntary basis; however, APHIS should consider industry practice in any further maintenance surveillance effort. Animals unsuitable for slaughter exhibiting symptoms not inconsistent with BSE should be sampled and their clinical signs recorded. However, this cited industry practice results in rejected animals not being made available to either APHIS or FSIS veterinarians for their observation and identification of clinical signs exhibited ante mortem. Although these animals may be sampled later at other collection sites, the animals are provided post mortem without information as to relevant clinical signs exhibited ante mortem. For these reasons, we believe APHIS needs to

USDA/OIG-A/50601-10-KC Page 27

observe these animals ante mortem when possible to assure the animals from the target population are ultimately sampled and the clinical signs evaluated.

snip...

http://www.usda.gov/oig/webdocs/50601-10-KC.pdf

USDA Testing Protocols and Quality Assurance Procedures

In November 2004, USDA announced that its rapid screening test produced an inconclusive BSE test result. A contract laboratory ran its rapid screening test on a brain sample collected for testing and produced three high positive reactive results. As required, the contract laboratory forwarded the inconclusive sample to APHIS’ National Veterinary Services Laboratories (NVSL) for confirmation. NVSL repeated the rapid screening test, which again produced three high positive reactive results. Following established protocol, NVSL ran its confirmatory test, an immunohistochemistry (IHC) test, which was interpreted as negative for BSE.

Faced with conflicting results between the rapid screening and IHC tests, NVSL scientists recommended additional testing to resolve the discrepancy but APHIS headquarters officials concluded that no further testing was necessary since testing protocols were followed and the confirmatory test was negative. In our discussions with APHIS officials, they justified their decision to not do additional testing because the IHC test is internationally recognized as the "gold standard" of testing. Also, they believed that

USDA/OIG-A/50601-10-KC/ Page iv

conducting additional tests would undermine confidence in USDA’s testing protocols.

OIG obtained evidence that indicated additional testing was prudent. We came to this conclusion because the rapid screening tests produced six high positive reactive results, the IHC tests conflicted, and various standard operating procedures were not followed. Also, our review of the relevant scientific literature, other countries’ protocols, and discussions with experts led us to conclude that additional confirmatory testing should be considered in the event of conflicting test results.

To maintain objectivity and independence, we requested that USDA’s Agricultural Research Service (ARS) perform the Office International des Epizooties (OIE) Scrapie-Associated Fibrils (SAF) immunoblot test. The additional testing produced positive results. To confirm, the Secretary of Agriculture requested that an internationally recognized BSE laboratory in Weybridge, England (Weybridge) perform additional testing. Weybridge conducted various tests, including their own IHC tests and three Western blot tests. The tests confirmed that the cow was infected with BSE. The Secretary immediately directed USDA scientists to work with international experts to develop new protocols that include performing dual confirmatory tests in the event of an inconclusive BSE screening test.

We attribute the failure to identify the BSE positive sample to rigid protocols, as well as the lack of adequate quality assurance controls over its testing program. Details of our concerns are discussed in Findings 3 and 4.

snip...

Section 2. Testing Protocols and Quality Assurance Controls In November 2004, USDA announced that its rapid screening test, Bio-Rad Enzyme Linked Immunosorbent Assay (ELISA), produced an inconclusive BSE test result as part of its enhanced BSE surveillance program. The ELISA rapid screening test performed at a BSE contract laboratory produced three high positive reactive results.40 As required,41 the contract laboratory forwarded the inconclusive sample to the APHIS National Veterinary Services Laboratories (NVSL) for confirmatory testing. NVSL repeated the ELISA testing and again produced three high positive reactive results.42 In accordance with its established protocol, NVSL ran its confirmatory test, an immunohistochemistry (IHC) test, which was interpreted as negative for BSE. In addition, NVSL performed a histological43 examination of the tissue and did not detect lesions44 consistent with BSE. Faced with conflicting results, NVSL scientists recommended additional testing to resolve the discrepancy but APHIS headquarters officials concluded no further testing was necessary because testing protocols were followed. In our discussions with APHIS officials, they justified their decision not to do additional testing because the IHC is internationally recognized as the “gold standard.” Also, they believed that conducting additional tests would undermine confidence in USDA’s established testing protocols. However, OIG obtained evidence that indicated additional testing was prudent to ensure that USDA’s testing protocols were effective in detecting BSE and that confidence in USDA’s testing procedures was maintained. OIG came to this conclusion because the rapid tests produced six high positive reactive results, confirmatory testing conflicted with the rapid test results, and various standard operating procedures were not followed. Also, our review of scientific literature, other country protocols, as well as discussions with internationally recognized experts led us to conclude that confirmatory testing should not be limited when conflicting test results are obtained. To maintain objectivity and independence in our assessment, we requested the USDA Agricultural Research Service (ARS) perform the Office International des Epizooties (OIE) Scrapie-Associated Fibrils (SAF) 40 ELISA test procedures require two additional (duplicate) tests if the initial test is reactive, before final interpretation. If either of the duplicate tests is reactive, the test is deemed inconclusive. 41 Protocol for BSE Contract Laboratories to Receive and Test Bovine Brain Samples and Report Results for BSE Surveillance Standard Operating Procedure (SOP), dated October 26, 2004. 42 The NVSL conducted an ELISA test on the original material tested at the contract laboratory and on two new cuts from the sample tissue. 43 A visual examination of brain tissue by a microscope. 44 A localized pathological change in a bodily organ or tissue.

immunoblot.45 ARS performed the test at the National Animal Disease Center because NVSL did not have the necessary equipment46 (ultracentrifuge) to do the test. APHIS scientists observed and participated, as appropriate, in this effort. The additional tests conducted by ARS produced positive results. To confirm this finding, the Secretary requested the internationally recognized BSE reference laboratory in Weybridge, England, (Weybridge) to perform additional confirmatory testing. Weybridge conducted various tests, including their own IHC methods, as well as three Western blot methods. The tests confirmed that the suspect cow was infected with BSE. Also, Weybridge confirmed this case as an unequivocal positive case of BSE on the basis of IHC. As a result of this finding, the Secretary immediately directed USDA scientists to work with international experts to develop a new protocol that includes performing dual confirmatory tests in the event of another inconclusive BSE screening test. Finding 3 Rigid Protocols Reduced the Likelihood BSE Could be Detected APHIS relied on a single test method, as well as a histological examination of tissue for lesions consistent with BSE, to confirm the presence of BSE even though discrepant test results indicated further testing may be prudent. When IHC test results were interpreted as negative, APHIS concluded the sample tested negative for BSE. Subsequent independent tests initiated by OIG using a different testing method, as well as confirmatory testing by Weybridge, determined that the suspect sample was a positive case of BSE. APHIS Declares BSE Sample Negative Despite Conflicting Results When the tissue sample originally arrived at NVSL in November 2004 from the contract lab, NVSL scientists repeated the ELISA screening test and again produced three high positive reactive results. NVSL scientists cut out two sections of the brain sample for IHC testing. One section was used for an experimental procedure that was not part of the confirmatory testing protocol, and the other cut was for normal IHC testing using scrapie for a positive control.47 According to NVSL scientists, the experimental test results were inconclusive but the IHC test was interpreted as negative. The NVSL scientists were concerned with the inconsistencies and conducted 45 The OIE SAF immunoblot is an internationally recognized confirmatory test, often referred to as a Western blot test. There are different types of Western blots; the OIE SAF immunoblot includes enrichment steps taken with the sample prior to the standard Western blot steps. 46 APHIS has now ordered the necessary equipment for NVSL. USDA/OIG-A/50601-10-KC Page 32

47 A positive control is a sample that is known to contain a given disease or react in the test. The sample then can be used to make sure that the test for that disease works properly. In the case of BSE, tissue infected with either scrapie or BSE can serve as a positive control for an IHC test for BSE since both are different forms of the same disease (transmissible spongiform encephalopathy or TSE).

another IHC test using BSE as a positive control.48 The test result was also interpreted as negative. Also, according to the NVSL scientists, the histological examination of the tissue did not detect lesions consistent with BSE. After the second negative IHC test, NVSL scientists supported doing additional testing. They prepared a plan for additional tests; if those tests had been conducted, BSE may have been detected in the sample. The additional tests recommended by NVSL scientists, but not approved by APHIS Headquarters officials, were the IHC using other antibodies (IHC testing using different antibodies ultimately produced positive results); IHC testing of additional regions of the brain (the cerebellum tested positive); regular and enriched (OIE-like) Western blots (the obex and cerebellum tested positive); and variable rapid tests (the obex and cerebellum tested positive with two different rapid tests). NVSL officials also recommended that the sample be sent to Weybridge for confirmatory testing (to conduct IHC and OIE Western blot tests). In June 2005, Weybridge conducted IHC testing with three different antibodies, including the antibody used in the United States (tested positive), the OIE Western blot (tested positive), a modified commercial kit Western blot (negative) and the NaPTA49 Western blot (tested positive). We obtained information as to the differing protocols used by other countries. We found that while APHIS determined that additional testing was unnecessary after the IHC test, other countries have used multiple tests to confirm positives. In Japan, for example, all reactive screening test samples are examined by both IHC and a Western blot (different from the OIE SAF immunoblot). In the United Kingdom (U.K.), IHC and Western blot (different from the OIE SAF immunoblot) tests are used for all animals that test positive with a screening test. When IHC and the Western blot fail to confirm a positive rapid test, the U.K. resorts to a third test, the OIE SAF immunoblot. With these procedures in place, both Japan and the U.K. have found BSE cases that were rapid test reactive, IHC negative, and finally confirmed positive with a Western blot. Evidence Indicated Additional Testing Would Be Prudent We also spoke with an internationally recognized BSE expert regarding the advisability of limiting confirmatory testing when conflicting results are obtained. This official expressed concern about limiting confirmatory tests to the IHC despite its status as one of the “gold standard” tests. He advised that the IHC is not one test; it is a test method that can vary significantly in sensitivity from laboratory to laboratory. New antibodies can improve or

USDA/OIG-A/50601-10-KC Page 33

48 The NVSL uses scrapie as the positive control as part of its normal IHC testing procedures. Due to the conflicting results between the ELISA and IHC tests, the NVSL conducted another IHC test with BSE as the positive control. Subsequently, the NVSL modified the Confirming Inconclusive Results from BSE Testing Laboratories at the NVSL SOP to show that all IHC tested BSE inconclusive samples from contract laboratories will use BSE as the positive control. 49 Sodium phosphotungstic acid.

USDA/OIG-A/50601-10-KC Page 34

reduce sensitivity, as can variations in many of the reagents50 used. He explained that his laboratory had experienced cases where an initial confirmatory IHC test was challenged by either a more extensive IHC test or “…applying a more sensitive immunoblot.” He emphasized the importance of having additional confirmatory testing to resolve discrepant results since there are many variables, and most of the variability appears to be due to test performance of the laboratory. OIG became concerned that APHIS relied on its confirmatory test methods when rapid screening tests produced high positive reactive results six times.51 Also, we found that APHIS did not pursue and/or investigate why the ELISA produced high reactive positives. An official from the manufacturer of the ELISA test kit told us that they requested, but did not receive, information on the inconclusive reported by USDA in November 2004. These officials requested this information in order to understand the reasons for the discrepant results. The Bio-Rad ELISA rapid screening test is internationally recognized as a highly reliable test and is the rapid screening test used for USDA’s surveillance effort. According to APHIS officials, they felt it would be inappropriate to collaborate on the one sample because Bio-Rad is a USDA-APHIS regulated biologics company and only one of several competing manufacturers. To maintain confidence in USDA’s test protocols, it would have been a prudent course of action for USDA to determine why such significant differing results were obtained. The fact that they did not pursue this matter caused concerns relating to testing quality assurance procedures. In this regard, we found lack of compliance with SOPs relating to laboratory proficiency and quality assurance (see Finding 4), and, in this case, the storage of sampled material and reporting of test results. We found that the NVSL did not prepare a report to document its confirmatory testing of the November 2004 sample. The SOP52 states that the BSE network laboratory initiating the inconclusive will receive a report of the case. NVSL officials could not explain why a final report had not been prepared. We also found that the inconclusive sample was frozen prior to IHC confirmatory testing. APHIS protocols state that samples are not to be frozen prior to laboratory submission. The OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals states that the tissues for histological or IHC examination are not to be frozen as this will provide artefactual53 lesions that may compromise the identification of vacuolation,54 and/or target site location. Although the sample was frozen, APHIS did not conduct a Western 50 A substance used in a chemical reaction to detect, measure, examine, or produce other substances. 51 The six high positive reactive results were from three tests of the submitted sample (multiple runs of the same test). 52 Confirming Inconclusive Results from Bovine Spongiform Encephalopathy Testing Laboratories at the NVSL SOP, dated August 13, 2004. 53 A structure or feature not normally present but visible as a result of an external agent or action, such as one seen in a microscopic specimen after fixation. 54 A small space or cavity in a tissue.

USDA/OIG-A/50601-10-KC Page 35

blot test on the sample. An NVSL official said freezing the sample does not make it unsuitable for IHC. APHIS determined that the sample was suitable for IHC and therefore, in accordance with its SOP, did not conduct a Western blot test. APHIS also handled the December 2003 BSE positive differently than the November 2004 sample. For the December 2003 BSE positive sample, APHIS conducted several confirmatory tests in addition to the IHC testing and histological examination (unlike the November 2004 sample tests, both of these were interpreted as positive). ARS performed two Western blots (Prionics Check Western blot and an ARS developed Western blot). When we questioned why the samples were handled differently, APHIS officials stated that the Western blots were done because the IHC in December 2003 was positive. The additional testing was done to further characterize the case, because it was the first U.S. case; the additional testing was not done to decide whether the case was positive or negative. We discussed our concerns with limiting confirmatory testing, particularly given conflicting results, with the APHIS Administrator and staff in May 2005. He explained that international standards recognized more than one “gold standard” test. In setting up its testing protocols, USDA had chosen one as the confirming test, the IHC test, and stayed with it. APHIS protocols only allow a Western blot in cases where the sample has become unsuitable for IHC tests (e.g., in cases where the brainstem architecture is not evident). International standards, he continued, accept a tissue sample as negative for BSE if its IHC test is negative. Once the test is run in accordance with protocols, additional tests undermine the USDA testing protocol and the surveillance program. He concluded that since APHIS’ protocols accepted the IHC test as confirming the presence or absence of BSE, no further testing was necessary. According to protocol, the tissue sample was determined to have tested negative for BSE. On June 24, 2005, USDA announced that the additional testing by the BSE reference laboratory in England confirmed the presence of BSE in the tissue sample. To obviate the possibility that a future sample would be declared negative and then found positive, the Secretary of Agriculture announced a change to APHIS’ testing protocols that same day. He called for “dual confirmatory tests in the event of another ‘inconclusive’ [reactive] BSE screening test.” He also indicated that he would reinforce proper procedures so that samples will not be frozen, and to spot-check the laboratories to see that they complete reports as required. APHIS issued a SOP on the new confirmatory testing protocols on November 30, 2005.

http://www.usda.gov/oig/webdocs/50601-10-KC.pdf

FDA has determined that each animal could have consumed, at most and in total, five-and-one-half grams - approximately a quarter ounce -- of prohibited material. These animals weigh approximately 600 pounds.

http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html

http://www.fda.gov/ora/about/enf_story/archive/2001/ch5/default.htm

====================================

Subject: MAD COW FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL,
TN, AND WV
Date: September 6, 2006 at 7:58 am PST

PRODUCT
a) EVSRC Custom dairy feed, Recall # V-130-6;
b) Performance Chick Starter, Recall # V-131-6;
c) Performance Quail Grower, Recall # V-132-6;
d) Performance Pheasant Finisher, Recall # V-133-6.
CODE
None
RECALLING FIRM/MANUFACTURER
Donaldson & Hasenbein/dba J&R Feed Service, Inc., Cullman, AL, by telephone
on June 23, 2006 and by letter dated July 19, 2006. Firm initiated recall is
complete.
REASON
Dairy and poultry feeds were possibly contaminated with ruminant based
protein.
VOLUME OF PRODUCT IN COMMERCE
477.72 tons
DISTRIBUTION
AL
______________________________
PRODUCT
a) Dairy feed, custom, Recall # V-134-6;
b) Custom Dairy Feed with Monensin, Recall # V-135-6.
CODE
None. Bulk product
RECALLING FIRM/MANUFACTURER
Recalling Firm: Burkmann Feed, Greeneville, TN, by Telephone beginning on
June 28, 2006.
Manufacturer: H. J. Baker & Bro., Inc., Albertville, AL. Firm initiated
recall is complete.
REASON
Possible contamination of dairy feeds with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
1,484 tons
DISTRIBUTION
TN and WV

http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html

Subject: MAD COW FEED RECALLS ENFORCEMENT REPORT FOR AUGUST 9, 2006 KY, LA,
MS, AL, GA, AND TN 11,000+ TONS
Date: August 16, 2006 at 9:19 am PST

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-115-6
CODE
None
RECALLING FIRM/MANUFACTURER
Hiseville Feed & Seed Co., Hiseville, KY, by telephone and letter on or
about July 14, 2006. FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
Approximately 2,223 tons
DISTRIBUTION
KY

______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-116-6
CODE
None
RECALLING FIRM/MANUFACTURER
Rips Farm Center, Tollesboro, KY, by telephone and letter on July 14, 2006.
FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
1,220 tons
DISTRIBUTION
KY

______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-117-6
CODE
None
RECALLING FIRM/MANUFACTURER
Kentwood Co-op, Kentwood, LA, by telephone on June 27, 2006. FDA initiated
recall is completed.
REASON
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
40 tons
DISTRIBUTION
LA and MS

______________________________
PRODUCT
Bulk Dairy Feed, Recall V-118-6
CODE
None
RECALLING FIRM/MANUFACTURER
Cal Maine Foods, Inc., Edwards, MS, by telephone on June 26, 2006. FDA
initiated recall is complete.
REASON
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
7,150 tons
DISTRIBUTION
MS

______________________________
PRODUCT
Bulk custom dairy pre-mixes, Recall # V-119-6
CODE
None
RECALLING FIRM/MANUFACTURER
Walthall County Co-op, Tylertown, MS, by telephone on June 26, 2006. Firm
initiated recall is complete.
REASON
Possible contamination of dairy animal feeds with ruminant derived meat and
bone meal.
VOLUME OF PRODUCT IN COMMERCE
87 tons
DISTRIBUTION
MS

______________________________
PRODUCT
Bulk custom dairy pre-mixes, Recall # V-120-6
CODE
None
RECALLING FIRM/MANUFACTURER
Ware Milling Inc., Houston, MS, by telephone on June 23, 2006. Firm
initiated recall is complete.
REASON
Possible contamination of dairy animal feeds with ruminant derived meat and
bone meal.
VOLUME OF PRODUCT IN COMMERCE
350 tons
DISTRIBUTION
AL and MS

______________________________
PRODUCT
a) Tucker Milling, LLC Tm 32% Sinking Fish Grower, #2680-Pellet,
50 lb. bags, Recall # V-121-6;
b) Tucker Milling, LLC #31120, Game Bird Breeder Pellet,
50 lb. bags, Recall # V-122-6;
c) Tucker Milling, LLC #31232 Game Bird Grower,
50 lb. bags, Recall # V-123-6;
d) Tucker Milling, LLC 31227-Crumble, Game Bird Starter, BMD
Medicated, 50 lb bags, Recall # V-124-6;
e) Tucker Milling, LLC #31120, Game Bird Breeder, 50 lb bags,
Recall # V-125-6;
f) Tucker Milling, LLC #30230, 30 % Turkey Starter, 50 lb bags,
Recall # V-126-6;
g) Tucker Milling, LLC #30116, TM Broiler Finisher,
50 lb bags, Recall # V-127-6
CODE
All products manufactured from 02/01/2005 until 06/20/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tucker Milling LLC, Guntersville, AL, by telephone and visit
on June 20, 2006, and by letter on June 23, 2006.
Manufacturer: H. J. Baker and Brothers Inc., Stamford, CT. Firm initiated
recall is ongoing.
REASON
Poultry and fish feeds which were possibly contaminated with ruminant based
protein were not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE
7,541-50 lb bags
DISTRIBUTION
AL, GA, MS, and TN

END OF ENFORCEMENT REPORT FOR AUGUST 9, 2006

###

http://www.fda.gov/bbs/topics/ENFORCE/2006/ENF00964.html

Subject: MAD COW FEED RECALL MI MAMMALIAN PROTEIN VOLUME OF PRODUCT IN
COMMERCE 27,694,240 lbs
Date: August 6, 2006 at 6:14 pm PST
PRODUCT
Bulk custom dairy feds manufactured from concentrates, Recall # V-113-6
CODE
All dairy feeds produced between 2/1/05 and 6/16/06 and containing H. J.
Baker recalled feed products.
RECALLING FIRM/MANUFACTURER
Vita Plus Corp., Gagetown, MI, by visit beginning on June 21, 2006. Firm
initiated recall is complete.
REASON
The feed was manufactured from materials that may have been contaminated
with mammalian protein.
VOLUME OF PRODUCT IN COMMERCE
27,694,240 lbs
DISTRIBUTION
MI

END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html

Subject: MAD COW FEED RECALL AL AND FL VOLUME OF PRODUCT IN COMMERCE 125
TONS Products manufactured from 02/01/2005 until 06/06/2006
Date: August 6, 2006 at 6:16 pm PST
PRODUCT
a) CO-OP 32% Sinking Catfish, Recall # V-100-6;
b) Performance Sheep Pell W/Decox/A/N, medicated,
net wt. 50 lbs, Recall # V-101-6;
c) Pro 40% Swine Conc Meal -- 50 lb, Recall # V-102-6;
d) CO-OP 32% Sinking Catfish Food Medicated,
Recall # V-103-6;
e) "Big Jim's" BBB Deer Ration, Big Buck Blend,
Recall # V-104-6;
f) CO-OP 40% Hog Supplement Medicated Pelleted,
Tylosin 100 grams/ton, 50 lb. bag, Recall # V-105-6;
g) Pig Starter Pell II, 18% W/MCDX Medicated 282020,
Carbadox -- 0.0055%, Recall # V-106-6;
h) CO-OP STARTER-GROWER CRUMBLES, Complete
Feed for Chickens from Hatch to 20 Weeks, Medicated,
Bacitracin Methylene Disalicylate, 25 and 50 Lbs,
Recall # V-107-6;
i) CO-OP LAYING PELLETS, Complete Feed for Laying
Chickens, Recall # 108-6;
j) CO-OP LAYING CRUMBLES, Recall # V-109-6;
k) CO-OP QUAIL FLIGHT CONDITIONER MEDICATED,
net wt 50 Lbs, Recall # V-110-6;
l) CO-OP QUAIL STARTER MEDICATED, Net Wt. 50 Lbs,
Recall # V-111-6;
m) CO-OP QUAIL GROWER MEDICATED, 50 Lbs,
Recall # V-112-6
CODE
Product manufactured from 02/01/2005 until 06/06/2006
RECALLING FIRM/MANUFACTURER
Alabama Farmers Cooperative, Inc., Decatur, AL, by telephone, fax, email and
visit on June 9, 2006. FDA initiated recall is complete.
REASON
Animal and fish feeds which were possibly contaminated with ruminant based
protein not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE
125 tons
DISTRIBUTION
AL and FL

END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html

Subject: MAD COW FEED RECALL KY VOLUME OF PRODUCT IN COMMERCE ?????
Date: August 6, 2006 at 6:19 pm PST
PRODUCT
Bulk custom made dairy feed, Recall # V-114-6
CODE
None
RECALLING FIRM/MANUFACTURER
Burkmann Feeds LLC, Glasgow, KY, by letter on July 14, 2006. Firm initiated
recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak, which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
?????
DISTRIBUTION
KY
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html

CJD WATCH MESSAGE BOARD
TSS
MAD COW FEED RECALL USA EQUALS 10,878.06 TONS NATIONWIDE
Sun Jul 16, 2006 09:22
71.248.128.67

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
______________________________
PRODUCT
a) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals,
Recall # V-079-6;
b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg),
Recall # V-080-6;
c) PRO-PAK, MARINE & ANIMAL PROTEIN CONCENTRATE FOR USE IN ANIMAL
FEED, Recall # V-081-6;
d) Feather Meal, Recall # V-082-6
CODE
a) Bulk
b) None
c) Bulk
d) Bulk
RECALLING FIRM/MANUFACTURER
H. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 and
by press release on June 16, 2006. Firm initiated recall is ongoing.
REASON
Possible contamination of animal feeds with ruminent derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
10,878.06 tons
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR July 12, 2006

###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html

Subject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006
Date: June 27, 2006 at 7:42 am PST
Public Health Service
Food and Drug Administration

New Orleans District
297 Plus Park Blvd.
Nashville, TN 37217

Telephone: 615-781-5380
Fax: 615-781-5391

May 17, 2006

WARNING LETTER NO. 2006-NOL-06

FEDERAL EXPRESS
OVERNIGHT DELIVERY

Mr. William Shirley, Jr., Owner
Louisiana.DBA Riegel By-Products
2621 State Street
Dallas, Texas 75204

Dear Mr. Shirley:

On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration
(FDA) investigator inspected your rendering plant, located at 509 Fortson
Street, Shreveport, Louisiana. The inspection 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). You failed to
follow the requirements of this regulation; products being manufactured and
distributed by your facility are misbranded within the meaning of Section
403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act
(the Act).

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

You failed to use clean-out procedures or other means adequate to prevent
carryover of protein derived from mammalian tissues into animal protein or
feeds which may be used for ruminants. For example, your facility uses the
same equipment to process mammalian and poultry tissues. However, you use
only hot water to clean the cookers between processing tissues from each
species. You do not clean the auger, hammer mill, grinder, and spouts after
processing mammalian tissues.

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 which may be used for ruminants.

As a result . the poultry meal you manufacture may contain protein derived
from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR
589.2000(e)(1)(i), any products containing or may contain protein derived
from mammalian tissues must be labeled, "Do not feed to cattle or other
ruminants." Since you failed to label a product which may contain protein
derived from mammalian tissues with the required cautionary statement. the
poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the
Act.

This letter is not intended as an all-inclusive list of violations at your
facility. As a manufacturer of materials intended for animal feed use, you
are responsible for ensuring your overall operation and the products you
manufacture and distribute are in compliance with the law. You should take
prompt action to correct these violations, and you should establish a system
whereby violations do not recur. Failure to promptly correct these
violations may result in regulatory action, such as seizure and/or
injunction, without further notice.

You should notify this office in writing within 15 working days of receiving
this letter, outlining the specific steps you have taken to bring your firm
into compliance with the law. Your response should include an explanation of
each step taken to correct the violations and prevent their recurrence. If
corrective action cannot be completed within 15 working days, state the
reason for the delay and the date by which the corrections will be
completed. Include copies of any available documentation demonstrating
corrections have been made.

Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S.
Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie,
Louisiana 70001. If you have questions regarding any issue in this letter,
please contact Mr. Rivero at (504) 219-8818, extension 103.

Sincerely,

/S

Carol S. Sanchez
Acting District Director
New Orleans District

http://www.fda.gov/foi/warning_letters/g5883d.htm

look at the table and you'll see that as little as 1 mg (or 0.001 gm) caused
7% (1 of 14) of the cows to come down with BSE;

Risk of oral infection with bovine spongiform encephalopathy agent in
primates

Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog,
Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie
Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe
Deslys
Summary The uncertain extent of human exposure to bovine spongiform
encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease
(vCJD)--is compounded by incomplete knowledge about the efficiency of oral
infection and the magnitude of any bovine-to-human biological barrier to
transmission. We therefore investigated oral transmission of BSE to
non-human primates. We gave two macaques a 5 g oral dose of brain homogenate
from a BSE-infected cow. One macaque developed vCJD-like neurological
disease 60 months after exposure, whereas the other remained free of disease
at 76 months. On the basis of these findings and data from other studies, we
made a preliminary estimate of the food exposure risk for man, which
provides additional assurance that existing public health measures can
prevent transmission of BSE to man.

snip...

BSE bovine brain inoculum

100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg

Primate (oral route)* 1/2 (50%)

Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%)
1/15 (7%)

RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)

PrPres biochemical detection

The comparison is made on the basis of calibration of the bovine inoculum
used in our study with primates against a bovine brain inoculum with a
similar PrPres concentration that was

inoculated into mice and cattle.8 *Data are number of animals
positive/number of animals surviving at the time of clinical onset of
disease in the first positive animal (%). The accuracy of

bioassays is generally judged to be about plus or minus 1 log. ic
ip=intracerebral and intraperitoneal.

Table 1: Comparison of transmission rates in primates and cattle infected
orally with similar BSE brain inocula

Published online January 27, 2005

http://www.thelancet.com/journal/journal.isa

It is clear that the designing scientists must

also have shared Mr Bradley's surprise at the results because all the dose

levels right down to 1 gram triggered infection.

http://www.bseinquiry.gov.uk/files/ws/s145d.pdf

[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)

http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf

[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk
Materials for Human Food and Requirement for the Disposition of
Non-Ambulatory Disabled Cattle

03-025IFA
03-025IFA-2

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

THE SEVEN SCIENTIST REPORT ***SRMs

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

PAUL BROWN M.D.

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

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

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

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

Embassy of Japan

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

03-025IF 03-025IF-631 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-631 Linda A. Detwiler Page 2. Page 3. Page 4.
Page 5. Page 6. Page 7. Page 8. Page 9. Page 10. Page 11. Page 12.

http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-631.pdf

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

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

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

http://www.fsis.usda.gov/Search/Search_Results/Index.asp?q=03-025IF&mode=simple&num=10&as_occt=any&restrict=FSIS_DOCKET_COMMENTS

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

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

Page 1 of 17 9/13/2005 [PDF]
... Page 1 of 17 From: Terry S. Singeltary Sr. [flounder9@verizon.net] Sent: Thursday,
September 08, 2005 6:17 PM To: fsis.regulationscomments@fsis.usda.gov Subject ...
www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf

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

Working Group Report on

the Assessment of the Geographical BSE-Risk (GBR) of

CANADA

2004

snip...

- 2 -

2. EXTERNAL CHALLENGES

2.1 Import of cattle from BSE-Risk2 countries

An overview of the data on live cattle imports is presented in table 1 and is based on

data as provided in the country dossier (CD) and corresponding data on relevant exports

as available from BSE risk countries that exported to Canada. Only data from risk

periods are indicated, i.e. those periods when exports from a BSE risk country already

represented an external challenge, according to the SSC opinion on the GBR (SSC July

2000 and updated January 2002).

• According to the CD, 231 cattle were imported from UK during the years 1980 to

1990 and no cattle imports from UK were recorded after 1990.

• According to Eurostat, altogether 198 cattle have been imported from the UK during

the years 1980 to 1990, Additionally 500 were recorded in 1993; this import is

1 For the purpose of the GBR assessment the abbreviation "MBM" refers to rendering products, in particular

the commodities Meat and Bone Meal as such; Meat Meal; Bone Meal; and Greaves. With regard to imports

it refers to the customs code 230110 "flours, meals and pellets, made from meat or offal, not fit for human

2 BSE-Risk countries are all countries already assessed as GBR III or IV or with at least one confirmed

Annex to the EFSA Scientific Report (2004) 2, 1-14 on the Assessment of the

Geographical BSE Risk of Canada

- 3 -

mentioned in Eurostat and the updated UK export statistic as male calves, but not

mentioned in the original UK export statistics. According to the CD, detailed

investigations were carried out and it is very unlikely that the 500 calves have been

imported. Therefore, they were not taken into account.

• According to the CD, in 1990 all cattle imported from UK and Ireland since 1982

were placed in a monitoring program.

• Following the occurrence of the BSE index case in 1993 (imported from UK in 1987

at the age of 6 months), an attempt was made to trace all other cattle imported from

UK between 1982 and 1990.

• Of the 231 cattle imported from the UK between 1980 and 1990, 108 animals had

been slaughtered and 9 had died. From the remaining, 37 were exported, 76 were

sent to incineration and one was buried; these were not entering the rendering system

and therefore not taken into account.

• According to the CD, 16 cattle were imported from Ireland (according to Eurostat

20), of which 9 were slaughtered, 3 died. The remaining 4 were incinerated and did

therefore not enter the rendering system. According to the CD, the 6 animals which

were imported in 1990 according to Eurostat, were never imported.

• Moreover 22 cattle have been imported from Japan (through USA), of which 4 were

exported (excluded from the table) and 14 were destroyed and therefore not entering

the rendering system, 4 were slaughtered.

• Of 28 imported bovines from Denmark, 1 was destroyed and 1 was exported. Of the

19 buffalos imported in 2000, 1 was incinerated and the others were ordered to be

destroyed.

• Additionally in total 264 cattle according to the CD (276 according to other sources)

were imported from Austria, France, Germany, Hungary, Italy, The Netherlands and

Switzerland.

• The numbers imported according to the CD and Eurostat are very similar. Some

discrepancies in the year of import can be explained by an extended quarantine;

therefore it is likely that imports according to Eurostat in 1980 and imports

according to the CD in 1981 are referring to the same animals.

• Additionally, between 16.000 and 340.000 bovines have annually been imported

from US, almost all are steers and heifers. In total, between 1981 and 2003,

according to the CD more than 2.3 million, according to other sources 1.5 million

cattle have been imported.

• According to the CD, feeder/slaughter cattle represent typically more than 90% of

the imported cattle from the USA; therefore, only 10% of the imported cattle have

been taken into account.

snip...

Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the

Geographical BSE Risk of Canada

2.2 Import of MBM or MBM-containing feedstuffs from BSE-Risk

countries

An overview of the data on MBM imports is presented in table 2 and is based on data

provided in the country dossier (CD) and corresponding data on relevant exports as

available from BSE risk countries that exported to Canada. Only data from risk periods

are indicated, i.e. those periods when exports from a BSE risk country already

represented an external challenge, according to the SSC opinion on the GBR (SSC, July

2000 and updated January 2002).

According to the CD, no imports of MBM took place from UK since 1978 (initially

because of FMD regulations).

• According to Eurostat data, Canada imported 149 tons MBM from the UK in the

period of 1993 to 2001. According to up-dated MBM statistics from UK (August

2001) no mammalian MBM was exported to Canada from 1993 – 1996. As it was

illegal to export mammalian meat meal, bone meal and MBM from UK since

27/03/1996, exports indicated after that date should only have included nonmammalian

MBM. Therefore, these imports were not taken into account.

• According to the CD, imports of MBM have taken place from Denmark, Germany,

France, Japan and US.

• According to Eurostat Canada imported MBM from Denmark, Belgium, France and

Ireland.

• According to the CD further investigations concluded that all imported MBM from

Denmark consisted of pork and poultry origin and was directly imported for

aquaculture, the imported MBM from France was feather meal, the imported MBM

from Germany was poultry meal for aquaculture and the imported MBM from

Belgium was haemoglobin; therefore these imports were not taken into account.

• The main imports of MBM were of US origin, according to the CD around 250.000

tons, according to other sources around 310.000 tons between 1988 and 2003.

snip...

2.3 Overall assessment of the external challenge

The level of the external challenge that has to be met by the BSE/cattle system is

estimated according to the guidance given by the SSC in its final opinion on the GBR of

July 2000 (as updated in January 2002).

Live cattle imports:

In total the country imported according to the CD more than 2.3 million, according to

other data 1.5 million live cattle from BSE risk countries, of which 231 (CD)

respectively 698 (other sources) came from the UK. The numbers shown in table 1 are

the raw import figures and are not reflecting the adjusted imports for the assessment of

the external challenge. Broken down to 5 year periods the resulting external challenge is

as given in table 3. This assessment takes into account the different aspects discussed

above that allow to assume that certain imported cattle did not enter the domestic

BSE/cattle system, i.e. were not rendered into feed. In the case of Canada, the 500 cattle

imported from UK according to Eurostat were not taken into account and it is assumed

that all incinerated, buried, exported animals and the animals still alive did not enter the

rendering system and were therefore excluded from the external challenge.

MBM imports:

In total the country imported according to the CD around 300.000 tons, according to

other sources nearly 360.000 tons of MBM from BSE risk countries, of which 149 tons

came from the UK. The majority consisted of MBM imported from the US. The

numbers shown in table 2 are the raw import figures and are not reflecting the adjusted

imports for the assessment of the external challenge. Broken down to 5 year periods the

resulting external challenge is as given in table 3. This assessment takes into account

the different aspects discussed above that allow to assume that certain imported MBM

did not enter the domestic BSE/cattle system or did not represent an external challenge

for other reasons. As it was illegal to export mammalian meat meal, bone meal and

MBM from UK since 27/03/1996, exports indicated after that date should only have

included non-mammalian MBM. In the case of Canada all imported MBM from UK,

Germany, Belgium, Denmark and France was not taken into account.

snip...

3. STABILITY

3.1 Overall appreciation of the ability to avoid recycling of BSE

infectivity, should it enter processing

Feeding

The annual Canadian production of MBM is approximately 575,000 tons of which

approx. 40,000 tons are exported each year, mainly to USA.

Use of MBM in cattle feed

• Before the feed ban, dairy cattle received supplementary feed containing MBM

during their productive life (maximum 200-400 g MBM per day). Beef cattle in the

western part of the country do not usually receive complementary feed. Beef cattle

in the eastern part receive normally no supplement protein but the calves could have

access to creep feeds containing MBM, after weaning the ratios may have contained

supplemental protein containing MBM (100-400 g per day).

• According to the CD, MBM is mainly fed to pigs and poultry and included in pet

food.

• According to the CD, only a proportion of dairy cattle may have received MBM.

Feed bans

• Before 1997, there was no legal restriction to include MBM into cattle feed.

• An MBM-ban was introduced in August 1997; it is forbidden since to feed

mammalian MBM to ruminants except if of pure porcine, equine and non

mammalian origin, i.e. in practice a ruminant-to-ruminant ban (RMBM-ban).

Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the

Geographical BSE Risk of Canada

- 9 -

Potential for cross-contamination and measures taken against

• Cross-contamination in the about 600 feed mills is assumed to be possible as long as

cattle and pig feed is produced in the same production lines, and premises.

• Cross-contamination during transport is possible, particularly if the same trucks are

used for transporting ruminant MBM (RMBM) and non-ruminant MBM (porcine or

poultry MBM which still might be included into cattle feed) or for transporting

pig/poultry feed and cattle feed.

• On-farm cross-contamination is regarded to be possible.

• Cross-contamination of cattle feed with RMBM can not be excluded. Hence, as

reasonable worst case scenario, it has to be assumed that cattle, in particular dairy

cattle, can still be exposed to RMBM and hence to BSE-infectivity, should it enter

the feed chain.

Control of Feed bans and cross-contamination

• With the introduction of the RMBM ban (1997) the feed mills (approximately 600)

were checked for compliance with the ban, including good manufacturing practices

(GMP) and record keeping, i.e. the separation in production of MBM containing

ruminant material (RMBM) from non-ruminant MBM.

• The feed mills had previously – since 1983 – been regularly checked in relation to

production of medicated feed.

• No examinations are performed to assess cross-contamination with RMBM of the

protein (e.g. non ruminant MBM) that enters cattle feed. Differentiation would

anyway be difficult.

Rendering

Raw material used for rendering

• Ruminant material is rendered together with material from other species, but

according to the CD only in the production of MBM prohibited for use in ruminant

feeds.

• Slaughter by-products, including specified risk material (SRM) and fallen stock are

rendered.

• The country expert estimated that 20% of the rendering plants, processing 20% of

the total amount of raw material, are connected to slaughterhouses. Their raw

material is more than 98 % animal waste from these slaughterhouses while less than

2 % is fallen stock. No estimation was given for the remaining 80% of the rendering

capacity.

• There are 32 rendering plants of which 3 are processing blood exclusively.

Rendering processes

• The rendering systems (parameters) were specified for 6 plants producing mixed

MBM, none of these fulfilled the 133/20/3 standard. Of these, 5 have dedicated

facilities to produce products for use in ruminant feed and products not permitted for

use in ruminant feed.

• The remaining plants process porcine or poultry material exclusively.

SRM and fallen stock

• There is an SRM ban for human food in place since 2003.

Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the

Geographical BSE Risk of Canada

- 10 -

• However, SRM are rendered together with other slaughter waste and fallen stock.

However, according to the CD, MBM with SRM is not permitted to be fed to

ruminants.

Conclusion on the ability to avoid recycling

• Between 1980 and 1997 the Canadian system would not have been able to avoid

recycling of the BSE-agent to any measurable extent. If the BSE-agent was

introduced into the feed chain, it could have reached cattle.

• Since 1997 this ability gradually improved with the introduction of the ruminant

MBM ban and its implementation.

• Since cross-contamination cannot be excluded, and as SRM is still rendered by

processes unable to significantly reduce BSE-infectivity, the system is still unable to

avoid recycling of BSE-infectivity already present in the system or incoming.

3.2 Overall appreciation of the ability to identify BSE-cases and to

eliminate animals at risk of being infected before they are processed

Cattle population structure

• Cattle population: 12.15 Million in 1988 increasing to 14.6 Million in 2001;

• Of the total cattle population, 2.2 million are dairy cattle and 12.4 million are beef.

• The cattle population above 24 months of age: approx. 6.0 Million.

• Of the approximately 2.2 Million dairy cattle 2 Million are located in the two eastern

provinces Ontario and Quebec.

• Mixed farming (cattle and mono-gastric species) is usually not practiced; the

country expert estimated the proportion of mixed farming to be less than 1%.

• Individual regions traditionally have ID systems under provincial authorities. Brand

inspectors are present when cattle are assembled. It is estimated by the Canadians

that the level of a national, uniform ID for cattle is less than 10%; most of those

individual pedigree animals. Mandatory ID for the milk-fed veal sector was

implemented in Quebec in 1996, but does not contain information on the herd of

origin. An agreement of the relevant industries to develop a national cattle ID and

trace back strategy was reached on 1 May 1998 (starting in 2001).Since 2002, a

national identification program is existing. Al cattle leaving any farm premises must

be uniquely identified by ear tag.

BSE surveillance

• BSE was made notifiable in 1990.

• Every cow over one year of age exhibiting central nervous system signs suggestive

of BSE submitted to a laboratory or presented at an abattoir is subjected to a BSE

laboratory diagnostic test (histology and over the past years also PrPSc-based

laboratory tests).

• In addition, cattle submitted for rabies examination and found rabies negative are

examined for BSE. Samples are prepared immediately upon arrival to the federal

laboratory responsible for the rabies diagnostic for possible later BSE examination,

i.e. formalin fixation.

• Since the 1940’s, a rabies control program has been in place, where farmers,

veterinarians and the general public are well educated about this neurological

Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the

Geographical BSE Risk of Canada

- 11 -

disease. In 1990, when BSE was made notifiable, this awareness was extended to

suspicions of BSE.

• Since 1993 the number of brains examined per year did exceed the number

recommended by OIE (300 - 336 for countries with a cattle population over 24

months of age of 5.0 to 7.0 Million) in all years, except in 1995 (table 4).

year 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003

samples 225 645 426 269 454 759 940 895 1´020 1´581 3´377 3´361

Table 4: Number of bovine brains annually examined for CNS diseases, including BSE.

• According to the CD approx. 98% of the examined cattle were older than 24 months

and approx. 90% exhibited neurological symptoms. Although the identification

system of Canada does not document the birth date or age of the animals, according

to the CD, examination of the dentition is used to ascertain the maturity of the

animals.

• The list of neurological differential diagnoses for the 754 brains examined in 1997

included encephalitis (70 cases), encephalomalacia (19), hemophilus (7),

hemorrhage (2), listeriosis (38), meningoencephalitis (36), rabies (22), tumors (2),

other conditions (135) and no significant findings (423).

• Compensation is paid for suspect BSE cases as well as for animals ordered to be

destroyed (90-95% of market value with a maximum of 2,500 Can$ per cow).

• Diagnostic criteria developed in the United Kingdom are followed at ADRI,

Nepean. According to the very detailed protocol for the collection, fixation and

submission of Bovine Spongiform Encephalopathy (BSE) specimens at abattoirs

under inspection by the Canadian Food Inspection Agency, the specimen shall be

shipped to National Center for Foreign Animal Disease, Winnipeg, Manitoba.

• In 2003, around 3000 animals from risk populations have been tested.

• According to the CD, it is aimed to test a minimum of 8000 risk animals (animals

with clinical signs consistent with BSE, downer cows, animals died on farm animals

diseased or euthanized because of serious illness) in 2004 and then continue to

progressively increase the level of testing to 30,000.

• In May 2003, Canada reported its first case of domestic BSE. A second case was

detected in the US on 23 December 2003 and traced back to Canadian origin. Both

were born before the feed ban and originated from Western Canada.

3.3 Overall assessment of the stability

For the overall assessment of the stability, the impact of the three main stability factors

(i.e. feeding, rendering and SRM-removal) and of the additional stability factor,

surveillance, has to be estimated. Again, the guidance provided by the SSC in its

opinion on the GBR of July 2000 (as updated January 2002) is applied.

Feeding

Until 1997, it was legally possible to feed ruminant MBM to cattle and a certain fraction of

cattle feed (for calves and dairy cattle) is assumed to have contained MBM. Therefore

feeding was "Not OK". In August 1997 a ruminant MBM ban was introduced but feeding

of non-ruminant MBM to cattle remained legal as well as feeding of ruminant MBM to

non-ruminant animals. This makes control of the feed ban very difficult because laboratory

differentiation between ruminant and non ruminant MBM is difficult if not impossible.

Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the

Geographical BSE Risk of Canada

Due to the highly specialised production system in Canada, various mammalian MBM

streams can be separated. Such a feed ban would therefore be assessed as "reasonably

OK", for all regions where this highly specialised system exists. However, several areas

in Canada do have mixed farming and mixed feed mills, and in such regions, an RMBM

ban would not suffice. Additionally, official controls for cattle feeds to control for the

compliance with the ban were not started until the end of 2003. Thus, for the whole

country, the assessment of the feeding after 1997 remains "Not OK".

Rendering

The rendering industry is operating with processes that are not known to reduce infectivity.

It is therefore concluded that the rendering was and is "Not OK".

SRM-removal

SRM and fallen stock were and are rendered for feed. Therefore SRM-removal is assessed

as "Not OK"

snip...

4.2 Risk that BSE infectivity entered processing

A certain risk that BSE-infected cattle entered processing in Canada, and were at least

partly rendered for feed, occurred in the early 1990s when cattle imported from UK in

the mid 80s could have been slaughtered. 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.

4.3 Risk that BSE infectivity was recycled and propagated

A risk that BSE-infectivity was recycled and propagated exists since a processing risk

first appeared; i.e. in the early 90s. Until today this risk persists and increases fast

because of the extremely unstable BSE/cattle system in Canada.

5. CONCLUSION ON THE GEOGRAPHICAL BSE-RISK

5.1 The current GBR as function of the past stability and challenge

The current geographical BSE-risk (GBR) level is III, i.e. it is confirmed at a lower level

that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent.

This assessment deviates from the previous assessment (SSC opinion, 2000) because at

that time several exporting countries were not considered a potential risk.

snip...

full text;

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

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)

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.

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

SUMMARY

Summary of Scientific Report
http://www.efsa.eu.int
1 of 1
Scientific Report of the European Food Safety Authority
on the Assessment of the Geographical BSE-Risk (GBR) of
United States of America (USA)
Question N° EFSA-Q-2003-083
Adopted July 2004
Summary of 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.
Key words: BSE, geographical risk assessment, GBR, USA, third countries

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573/sr03_biohaz02_usa_report_summary_en1.pdf

REPORT (6 PAGES)

snip...

EFSA Scientific Report (2004) 3, 1-6 on the Assessment of the Geographical BSE Risk of
Conclusions
The European Food Safety Authority concludes:
1. The BSE agent was probably imported into USA and could have reached domestic
cattle in the middle of the eighties. This 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 meat and bone meal (MBM) imported into the USA
reached domestic cattle and lead to an internal challenge in the early nineties.
2. 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.
3. The current geographical BSE risk (GBR) level is III, i.e. it is likely but not confirmed
that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent.
4. This assessment deviates from the previous assessment (SSC opinion, 2000) because
at that time several exporting countries were not considered a potential risk.
5. It is also worth noting that the current GBR conclusions are not dependent on the large
exchange of imports between USA and Canada. External challenge due to exports to
the USA from European countries varied from moderate to high. These challenges
indicate that it was likely that BSE infectivity was introduced into the North American
continent.
6. EFSA and its Scientific Expert Working group on GBR are concerned that the
available information was not confirmed by inspection missions as performed by the
Food and Veterinary office (FVO – DG SANCO) in Member States and other third
countries. They recommend including, as far as feasible, BSE-related aspects in
future inspection missions.
Expected development of the GBR
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.
A table summarising the reasons for the current assessment is given in the table below

snip...

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573/sr03_biohaz02_usa_report_v2_en1.pdf

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of Mexico
Last updated: 08 September 2004
Adopted July 2004 (Question N° EFSA-Q-2003-083)

Report

http://www.efsa.eu.int
3 of 6
Conclusions
The European Food Safety Authority concludes:
1. The BSE agent was probably imported into Mexico and could have reached domestic
cattle. These cattle imported could have been rendered and therefore led to an internal
EFSA Scientific Report (2004) 4, 1-6 on the Assessment of the Geographical BSE Risk of
challenge in the mid to late 1990’s. It is possible that imported MBM into Mexico
reached domestic cattle and leads to an internal challenge around 1993.
2. It is likely that BSE infectivity entered processing at the time of imported ‘at - risk’
MBM (1993) and at the time of slaughter of imported live ‘at - risk’ cattle (mid to late
1990s). The high level of external challenge is maintained throughout the reference
period, and the system has not been made stable. Thus it is likely that BSE infectivity
was recycled and propagated from approximately 1993. The risk has since grown
consistently due to a maintained internal and external challenge and lack of a stable
system.
3. The current geographical BSE risk (GBR) level is III, i.e. it is likely but not confirmed
that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent.
4. EFSA and its Scientific Expert Working group on GBR are concerned that the
available information was not confirmed by inspection missions as performed by the
Food and Veterinary office (FVO – DG SANCO) in Member States and other third
countries. They recommend including, as far as feasible, BSE-related aspects in
future inspection missions.

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/565/sr04_biohaz02_mexico_report_v2_en1.pdf

Summary

Summary of Scientific Report
http://www.efsa.eu.int
1 of 2
Scientific Report of the European Food Safety Authority
on the Assessment of the Geographical BSE-Risk (GBR) of
MEXICO
Question N° EFSA-Q-2003-083
Adopted July 2004
SUMMARY OF 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 Mexico, i.e. the likelihood of the presence of one or more cattle being infected
with BSE, pre-clinically as well as clinically, in Mexico. This scientific report addresses the
GBR of Mexico as assessed in 2004 based on data covering the period 1980-2003.
The BSE agent was probably imported into Mexico and could have reached domestic cattle.
These cattle imported could have been rendered and therefore led to an internal challenge in
the mid to late 1990s. It is possible that imported meat and bone meal (MBM) into Mexico
reached domestic cattle and leads to an internal challenge around 1993.
It is likely that BSE infectivity entered processing at the time of imported ‘at - risk’ MBM
(1993) and at the time of slaughter of imported live ‘at - risk’ cattle (mid to late 1990s). The
high level of external challenge is maintained throughout the reference period, and the system
has not been made stable. Thus it is likely that BSE infectivity was recycled and propagated
from approximately 1993. The risk has since grown consistently due to a maintained internal
and external challenge and lack of a stable system.
EFSA concludes that the current geographical BSE risk (GBR) level is III, i.e. it is likely
but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSEagent.
The GBR is likely to increase due to continued internal and external challenge, coupled
with a very unstable system.
Key words: BSE, geographical risk assessment, GBR, Mexico, third countries
Summary of Scientific Report
http://www.efsa.eu.int
2 of 2

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/565/sr04_biohaz02_mexico_report_summary_en1.pdf

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 Mexico, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in Mexico. This scientific report addresses the GBR of Mexico as assessed in 2004 based on data covering the period 1980-2003.

The BSE agent was probably imported into Mexico and could have reached domestic cattle. These cattle imported could have been rendered and therefore led to an internal challenge in the mid to late 1990s. It is possible that imported meat and bone meal (MBM) into Mexico reached domestic cattle and leads to an internal challenge around 1993.

It is likely that BSE infectivity entered processing at the time of imported ‘at - risk’ MBM (1993) and at the time of slaughter of imported live ‘at - risk’ cattle (mid to late 1990s). The high level of external challenge is maintained throughout the reference period, and the system has not been made stable. Thus it is likely that BSE infectivity was recycled and propagated from approximately 1993. The risk has since grown consistently due to a maintained internal and external challenge and lack of a stable system.

EFSA concludes that the current geographical BSE risk (GBR) level is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. The GBR is likely to increase due to continued internal and external challenge, coupled with a very unstable system.

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/565_en.html

ONE YEAR PREVIOUSLY ;

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

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