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From: TSS ()
Subject: Dr. Barbara Masters Food Safety and Inspection Service USDA BSE Roundtable The University of Minnesota St. Paul, Minnesota June 9, 2005
Date: June 9, 2005 at 1:42 pm PST

Release No. 0203.05
Office of Communications (202) 720-4623

REMARKS AS PREPARED FOR DELIVERY By Acting Administrator, Dr. Barbara Masters The Food Safety and Inspection Service U.S. Department of Agriculture BSE Roundtable The University of Minnesota St. Paul, Minnesota June 9, 2005

Good morning everyone. Today, I will focus my remarks on the public health aspects of BSE.

The Food Safety and Inspection Service (FSIS) uses science-based policies to effectively protect the health and well being of consumers worldwide against the threat of BSE and other food safety threats. Science-based policies are built on the public health model, which includes: assessment, policy development and assurance, or verification of effectiveness.

Historical Perspective

For more than a decade, the U.S. Department of Agriculture has had an aggressive program in place for surveillance, detection, and response to BSE. This program is led by APHIS, which has the responsibility for the health of live animals.

FSIS plays a strong role in the identification of samples from high-risk animals for this program. FSIS has over 7,500 inspection personnel in approximately 6,300 slaughter or processing establishments each and every day verifying the safety of meat, poultry and egg products. This includes identification and condemnation of cattle showing central nervous system symptoms on ante-mortem inspection.

The authority to monitor and enforce the animal feed ban rests with the Food and Drug Administration.

Our actions involved extensive collaboration among our agencies. Together we implemented regulatory actions and policy changes to create multiple firewalls to strengthen and protect against the introduction and spread of BSE in U.S. cattle and against human exposure to the BSE agent.

The detection of a single case of BSE in a cow imported from Canada on December 23, 2003 led us to further strengthen our BSE safeguards to protect human health.

I will now focus on FSIS' BSE measures that were taken following that finding.

On December 30, 2003, one week after the announcement of the positive BSE animal, then Secretary of Agriculture Ann Veneman, made a major policy announcement--the prohibition of the slaughter of non-ambulatory disabled cattle from the food supply, the removal of Specified Risk Materials from the food supply, as well as other actions to protect human and animal health.

Ban on Non-Ambulatory Disabled Cattle

USDA immediately put the ban on non-ambulatory disabled cattle into effect. These animals were considered unfit for human food.

FSIS' public health veterinarians are responsible for enforcing this ban, and we have provided them with training on when cattle are to be condemned at slaughter.

Following USDA's ban on non-ambulatory disabled cattle, FSIS issued four Federal Register documents, three rules and one notice.

These regulations were published within 20 days after the positive finding in Washington State. The process for publishing such rules normally would have taken several months to years.

FSIS had already done considerable work that laid the groundwork for these interim final rules. Several proactive measures had already been implemented to safeguard our beef supply not only for U.S. consumers but for our trading partners around the world.

Using science as a foundation, based in part on the Harvard-BSE risk assessment, we were able to take immediate action. This risk assessment reviewed available scientific information related to BSE and other TSEs; assessed pathways by which BSE could potentially occur in the United States and identified measures that could be taken to protect human and animal health in the United States.

The key findings of the Harvard BSE risk assessment were used in conjunction with the most current scientific literature and information from the BSE epidemic in the United Kingdom and elsewhere in Europe. This information was used to develop the interim final rules to address the food safety concerns arising from the finding of BSE in the United States.

I will now briefly summarize the interim final rules.

Test and Hold

First, FSIS issued a notice providing that any animals that are tested for BSE will not be marked as "inspected and passed" until our public health veterinarian receives confirmation that the cattle have, in fact, tested negative for BSE. We are referring to this as the "test-and-hold" policy.

Specified Risk Materials

FSIS published a second document, an interim final rule, to require that "specified risk materials" or SRMs from cattle do not enter the food supply.

We identified the brain, skull, eyes, trigeminal ganglia, spinal cord, central portions of the vertebral column and dorsal root ganglia of cattle 30 months of age and older as SRMs. Additionally we declared the tonsils and distal ileum of all cattle as SRMs. All SRMs are prohibited for use as human food.

This list of SRMs is consistent with international guidelines and actions taken by Canada. FDA took a similar action with the foods they regulate.

Banning SRMs from the food supply represents the most effective firewall for protecting public health.

Advanced Meat Recovery

The second rule involved product produced using advanced meat recovery (AMR). FSIS had previously established and enforced regulations that prohibit spinal cord from being included in AMR products labeled as "meat."

This rule expanded that prohibition to include dorsal root ganglia, or DRG. DRG are clusters of nerve cells along the vertebral column, in addition to the spinal cord tissue. Also, because the vertebral column and skull in cattle 30 months and older are considered inedible, we do not allow them to be used in processing Advance Meat Recovery products.

Banning Air-Injection Stunning

Finally, the third rule banned air-injection stunning equipment. This was done to ensure that portions of the brain are not dislocated into the tissues of the carcass as a consequence of stunning cattle during the slaughter process.

While the use of this type of stunning device is not common, officially banning its use not only ensures that it will be prohibited domestically, but will also make it a requirement for equivalency in establishments outside the United States when slaughtering for export to the U.S.

Summary of Actions

The actions I just reviewed are all science-based measures, designed to further minimize potential human exposure to the BSE agent through the consumption of beef and beef food products.

In addition to these actions, FSIS began collecting and submitting samples from ante-mortem condemned cattle to the APHIS enhanced surveillance program.

Stakeholder Feedback

To allow interested parties and stakeholders the opportunity to comment on the additional regulatory and policy measures under consideration FSIS, APHIS, and FDA published a joint advance notice of proposed rulemaking, or ANPR, to inform the public about what these agencies plan for keeping BSE out of the U.S.

Each agency laid out questions to solicit feedback. FSIS specifically sought comments on whether a country's BSE status should be taken into account when determining whether a country's meat inspection system is equivalent to the U.S. regulations including the provisions in the FSIS interim final rules.

In addition to the more than 22,000 comments we received, to help finalize our BSE rules, we will be reviewing data from APHIS' enhanced BSE surveillance program once it is completed. Additionally, we will review data from the updated Harvard BSE Risk Assessment that is being revised to evaluate the impacts of the FSIS interim final rules.

In the interim, through these rules-Banning Non-Ambulatory Disabled Cattle; Removing Specified Risk Materials; and Banning Air-Injection Stunning- in concert with FDA's feed ban and APHIS' surveillance program, FSIS is confident that we have an effective system, which protects public health.


The single BSE case in the United States led to changes and reevaluations of food safety system across our country.

It also led to an opportunity to build upon the strong partnerships we have with our sister agencies, APHIS, FDA, and other organizations.

Together, we must continue to rely on science-based solutions to prevent BSE from affecting animal and public health.

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