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[Federal Register: April 25, 2008 (Volume 73, Number 81)] [Rules and
Regulations] [Page 22719-22758] From the Federal Register Online via GPO
Access [wais.access.gpo.gov] [DOCID:fr25ap08-8]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 589

[Docket No. 2002N-0273] (Formerly Docket No. 02N-0273) RIN 0910-AF46

Substances Prohibited From Use in Animal Food or Feed

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the agency's
regulations to prohibit the use of certain cattle origin materials in the
food or feed of all animals. These materials include the following: The
entire carcass of bovine spongiform encephalopathy (BSE)-positive cattle;
the brains and spinal cords from cattle 30 months of age and older; the
entire carcass of cattle not inspected and passed for human consumption that
are 30 months of age or older from which brains and spinal cords were not
removed; tallow that is derived from BSE-positive cattle; tallow that is
derived from other materials prohibited by this rule that contains more than
0.15 percent insoluble impurities; and mechanically separated beef that is
derived from the materials prohibited by this rule. These measures will
further strengthen existing safeguards against BSE.

DATES: This final rule is effective April 27, 2009. The Director of the
Office of the Federal Register approves the incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of a certain publication
in new 21 CFR 589.2001 effective April 27, 2009.

FOR FURTHER INFORMATION CONTACT: Burt Pritchett, Center for Veterinary
Medicine (HFV-222), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-453-6860, e-mail: [email protected]

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction II. Comments on the Proposed Rule A. General Comments B.
Comments on Proposed New Sec. 589.2001--Cattle Materials Prohibited in
Animal Food or Feed C. Comments on Proposed Amendments to Sec.
589.2000--Animal Proteins Prohibited in Ruminant Feed III. Description of
the Final Rule A. Definitions B. Requirements C. Recordkeeping and Access
Requirements D. Changes to Sec. 589.2000--Animal Proteins Prohibited in
Ruminant Feed IV. Analysis of Economic Impacts A. Summary of Final
Regulatory Impact Analysis B. Cost Effectiveness of Final Rule and
Alternatives C. Need for Regulation D. Benefits E. Costs F. Government Costs
G. Sensitivity Analysis H. Regulatory Flexibility Analysis V. The Small
Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) VI. Paperwork
Reduction Act of 1995 VII. Environmental Impact VIII. Federalism IX.
References

I. Introduction

snip...see different commentors and replies back ;

(Comment 6) A few comments asked FDA to recognize that the USDA 18- month
surveillance snapshot may not be an accurate indication of BSE prevalence in
the United States. Specifically, because the BSE cases to date are likely
clustered in time and location, USDA's surveillance results may
underestimate the true risk.

(Response) FDA stated in the preamble to the proposed rule that the
detection of one BSE case in over 418,000 samples analyzed under USDA's
enhanced surveillance program at the time of the publication of the proposed
rule indicates that the prevalence of BSE is very low in the U.S. cattle
population. FDA notes that USDA has conducted surveillance for BSE since
1990. A July 20, 2006, USDA report entitled ``An Estimate of the Prevalence
of BSE in the United States'' supports FDA's qualitative statement of a very
low prevalence of BSE in the United States (Ref. 3). According to the
report, a model developed in Europe was used to calculate U.S. BSE
prevalence from two BSE cases detected in 735,213 samples collected over a
7-year period ending in March 2006. Results of this analysis support a
conclusion that the prevalence of BSE in the U.S. cattle population is less
than one infected animal per million adult cattle. FDA remains confident in
the two models used by USDA. The most likely values calculated by these
models for the estimated number of cases were 4 or 7 infected animals out of
42 million adult cattle. USDA's analysis was submitted to the scrutiny of a
peer review process, and the expert panel agreed with the appropriateness of
USDA's assumptions and the factors it considered, as well as with the
estimate of BSE prevalence.

(Comment 7) One comment noted that the effectiveness of the feed ban,
especially at the farm level, is not known.

(Response) Inspection results indicate that compliance by U.S. animal feed
industry is high. However, FDA agrees that it is very difficult to assess
compliance with the ruminant feed rule at the farm level. FDA believes
excluding certain cattle-derived risk materials from all animal feed
channels will minimize any residual risks from on- farm misfeeding.

(Comment 8) Two comments indicated that the agency's feed control measures
for ensuring compliance with the 1997 ruminant feed rule have been
inadequate, citing a Government Accountability Office (GAO) study as
evidence.

(Response) FDA disagrees with these comments. FDA believes its enforcement
activities are adequate for ensuring industry compliance with the 1997
ruminant feed rule. The agency's response to the GAO's study can be found in
Appendix VI of the GAO's report (Ref. 4).

(Comment 9) One comment speculated that, in some species, atypical BSE might
be more pathogenic than typical BSE.

(Response) FDA is not aware of any scientific evidence that atypical BSE is

[[Page 22724]]

more pathogenic than typical BSE. Therefore, the agency believes that the
controls in this final rule are appropriate.

full text ;

http://edocket.access.gpo.gov/2008/08-1180.htm

========================PLEASE NOTE TSS 2008=====================

***2008 Atypical forms of BSE have emerged which, although rare, appear to
be more virulent than the classical BSE that causes vCJD.

Pierluigi Gambetti, MD Director, National Prion Disease Pathology
Surveillance Center

Stephen M. Sergay, MB, BCh President, American Academy of Neurology

Progress Report from the National Prion Disease Pathology Surveillance
Center An Update from Stephen M. Sergay, MB, BCh & Pierluigi Gambetti, MD

April 3, 2008

http://www.aan.com/news/?event=read&article_id=4397&page=72.45.45


=======================PLEASE NOTE TSS 2008======================


April 25, 2008

Strengthening Beef Safety

The Food and Drug Administration (FDA) has issued a final regulation barring
certain cattle materials from all animal feed, including pet food. FDA
regulates animal feed and drugs. The U.S. Department of Agriculture (USDA)
regulates meat. Together the agencies enforce regulations that ensure that
specific risk materials are kept out of the human food supply.

http://www.fda.gov/consumer/updates/beefsafety042508.html


Greetings again,

IS this strengthening beef safety, or dangling another carrot out in front
of the consumer $$$

NOTHING but ink on paper. since the 8/4/97 partial and voluntary ruminant to
ruminant feed ban was put in place, the fda has failed time and time again,
with 100s of millions of pounds of banned mad cow feed going into commerce
and fed out. in just one fda letter in 2007, 10,000,000 plus pounds of
banned mad cow feed was fed out to commerce. REMEMBER, 1 GRAM could
EXPOSE/kill many cows. ...TSS

10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. MBM IN COMMERCE USA
2007

Date: March 21, 2007 at 2:27 pm PST REASON Blood meal used to make cattle
feed was recalled because it was cross-contaminated with prohibited bovine
meat and bone meal that had been manufactured on common equipment and
labeling did not bear cautionary BSE statement. VOLUME OF PRODUCT IN
COMMERCE 42,090 lbs. DISTRIBUTION WI

REASON Products manufactured from bulk feed containing blood meal that was
cross contaminated with prohibited meat and bone meal and the labeling did
not bear cautionary BSE statement. VOLUME OF PRODUCT IN COMMERCE 9,997,976
lbs. DISTRIBUTION ID and NV

END OF ENFORCEMENT REPORT FOR MARCH 21, 2007

http://www.fda.gov/bbs/topics/enforce/2007/ENF00996.html

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

REASON Dairy and poultry feeds were possibly contaminated with ruminant
based protein. VOLUME OF PRODUCT IN COMMERCE 477.72 tons DISTRIBUTION AL

VOLUME OF PRODUCT IN COMMERCE 1,484 tons DISTRIBUTION TN and WV

http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html

Wednesday, April 23, 2008

FDA Strengthens Safeguards for Consumers of Beef Issues Regulation on Animal
Feeds with Added Safeguards Against BSE

http://madcowfeed.blogspot.com/

2006 was a banner year too for mad cow protein. those were just one of many
;

Specified Risk Materials

http://madcowspontaneousnot.blogspot.com/2008/02/specified-risk-materials-srm.html

*** DO NOT forget what was originally promised years ago !!!

Press Release FOR IMMEDIATE RELEASE Monday, Jan. 26, 2004 FDA Press Office
301-827-6242

Expanded "Mad Cow" Safeguards Announced to Strengthen Existing Firewalls
Against BSE Transmission HHS Secretary Tommy G. Thompson today announced
several new public health measures, to be implemented by the Food and Drug
Administration (FDA), to strengthen significantly the multiple existing
firewalls that protect Americans from exposure to the agent thought to cause
bovine spongiform encephalopathy (BSE, also known as mad cow disease) and
that help prevent the spread of BSE in U.S. cattle.

The existing multiple firewalls, developed by both the U.S. Department of
Agriculture (USDA) and HHS, have been extremely effective in protecting the
American consumer from exposure to BSE. The first firewall is based on
import controls started in 1989. A second firewall is surveillance of the
U.S. cattle population for the presence of BSE, a USDA firewall that led to
the finding of the BSE cow in December. The third firewall is FDA's 1997
animal feed ban, which is the critical safeguard to help prevent the spread
of BSE through cattle herds by prohibiting the feeding of most mammalian
protein to ruminant animals, including cattle. The fourth firewall, recently
announced by USDA, makes sure that no bovine tissues known to be at high
risk for carrying the agent of BSE enter the human food supply regulated by
USDA. The fifth firewall is effective response planning to contain the
potential for any damage from a BSE positive animal, if one is discovered.
This contingency response plan, which had been developed over the past
several years, was initiated immediately upon the discovery of a BSE
positive cow in Washington State December 23.

The new safeguards being announced today are science-based and further
bolster these already effective safeguards.

Specifically, HHS intends to ban from human food (including dietary
supplements), and cosmetics a wide range of bovine-derived material so that
the same safeguards that protect Americans from exposure to the agent of BSE
through meat products regulated by USDA also apply to food products that FDA
regulates.

FDA will also prohibit certain currently allowed feeding and manufacturing
practices involving feed for cattle and other ruminant animals. These
additional measures will further strengthen FDA's 1997 "animal feed" rule.

"Today's actions will make strong public health protections against BSE even
stronger," Secretary Thompson said. "Although the current animal feed rule
provides a strong barrier against the further spread of BSE, we must never
be satisfied with the status quo where the health and safety of our animals
and our population is at stake. The science and our own experience and
knowledge in this area are constantly evolving. Small as the risk may
already be, this is the time to make sure the public is protected to the
greatest extent possible."

"Today we are bolstering our BSE firewalls to protect the public," said FDA
Commissioner Mark B. McClellan, M.D., Ph.D. "We are further strengthening
our animal feed rule, and we are taking additional steps to further protect
the public from being exposed to any potentially risky materials from
cattle. FDA's vigorous inspection and enforcement program has helped us
achieve a compliance rate of more than 99 percent with the feed ban rule,
and we intend to increase our enforcement efforts to assure compliance with
our enhanced regulations. Finally, we are continuing to assist in the
development of new technologies that will help us in the future improve even
further these BSE protections. With today's actions, FDA will be doing more
than ever before to protect the public against BSE by eliminating additional
potential sources of BSE exposure."

To implement these new protections, FDA will publish two interim final rules
that will take effect immediately upon publication, although there will be
an opportunity for public comment after publication.

The first interim final rule will ban the following materials from
FDA-regulated human food, (including dietary supplements) and cosmetics:

Any material from "downer" cattle. ("Downer" cattle are animals that cannot
walk.) Any material from "dead" cattle. ("Dead" cattle are cattle that die
on the farm (i.e. before reaching the slaughter plant); Specified Risk
Materials (SRMs) that are known to harbor the highest concentrations of the
infectious agent for BSE, such as the brain, skull, eyes, and spinal cord of
cattle 30 months or older, and a portion of the small intestine and tonsils
from all cattle, regardless of their age or health; and The product known as
mechanically separated beef, a product which may contain SRMs. Meat obtained
by Advanced Meat Recovery (an automated system for cutting meat from bones),
may be used since USDA regulations do not allow the presence of SRMs in this
product. The second interim final rule is designed to lower even further the
risk that cattle will be purposefully or inadvertently fed prohibited
protein. It was the feeding of such protein to cattle that was the route of
disease transmission that led to the BSE epidemic in United Kingdom cattle
in the 1980's and 1990's.

This interim final rule will implement four specific changes in FDA's
present animal feed rule. First, the rule will eliminate the present
exemption in the feed rule that allows mammalian blood and blood products to
be fed to other ruminants as a protein source. Recent scientific evidence
suggests that blood can carry some infectivity for BSE.

Second, the rule will also ban the use of "poultry litter" as a feed
ingredient for ruminant animals. Poultry litter consists of bedding, spilled
feed, feathers, and fecal matter that are collected from living quarters
where poultry is raised. This material is then used in cattle feed in some
areas of the country where cattle and large poultry raising operations are
located near each other. Poultry feed may legally contain protein that is
prohibited in ruminant feed, such as bovine meat and bone meal. The concern
is that spillage of poultry feed in the chicken house occurs and that
poultry feed (which may contain protein prohibited in ruminant feed) is then
collected as part of the "poultry litter" and added to ruminant feed.

Third, the rule will ban the use of "plate waste" as a feed ingredient for
ruminants. Plate waste consists of uneaten meat and other meat scraps that
are currently collected from some large restaurant operations and rendered
into meat and bone meal for animal feed. The use of "plate waste" confounds
FDA's ability to analyze ruminant feeds for the presence of prohibited
proteins, compromising the Agency's ability to fully enforce the animal feed
rule.

Fourth, the rule will further minimize the possibility of
cross-contamination of ruminant and non-ruminant animal feed by requiring
equipment, facilities or production lines to be dedicated to non-ruminant
animal feeds if they use protein that is prohibited in ruminant feed.
Currently, some equipment, facilities and production lines process or handle
prohibited and non-prohibited materials and make both ruminant and
non-ruminant feed -- a practice which could lead to cross-contamination.

To accompany these new measures designed to provide a further layer of
protection against BSE, FDA will in 2004 step up its inspections of feed
mills and renderers. FDA will itself conduct 2,800 inspections and will make
its resources go even further by continuing to work with state agencies to
fund 3,100 contract inspections of feed mill and renderers and other firms
that handle animal feed and feed ingredients. Through partnerships with
states, FDA will also receive data on 700 additional inspections, for a
total of 3,800 state contract and partnership inspections in 2004 alone,
including annual inspections of 100 percent of all known renderers and feed
mills that process products containing materials prohibited in ruminant
feed.

"We have worked hard with the rendering and animal feed production
industries to try and achieve full compliance with the animal feed rule,"
said Dr. McClellan, "and through strong education and a vigorous enforcement
campaign, backed by additional inspections and resources, we intend to
maintain a high level of compliance."

Dr. McClellan also noted that, in response to finding a BSE positive cow in
Washington state December 23, FDA inspected and traced products at 22
facilities related to that positive cow or products from the cow, including
feed mills, farms, dairy farms, calf feeder lots, slaughter houses, meat
processors, transfer stations, and shipping terminals. Moreover, FDA has
conducted inspections at the rendering facilities that handled materials
from the positive cow, and they were found to be fully in compliance with
FDA's feed rule.

To further strengthen protections for Americans, FDA/HHS intends to work
with Congress to consider proposals to assure that these important
protective measures will be implemented as effectively as possible.

FDA is also continuing its efforts to assist in the development of better
BSE science, to achieve the same or greater confidence in BSE protection at
a lower cost. For example, to enhance the ability of our public health
system to detect prohibited materials in animal feed, FDA will continue to
support the development and evaluation of diagnostic tests to identify
prohibited materials. These tests would offer a quick and reliable method of
testing animal feeds for prohibited materials and for testing other products
for contamination with the agent thought to cause BSE.

FDA has publicly discussed many of the measures being announced today with
stakeholders in workshops, videoconferences, and public meetings. In
addition, FDA published an Advance Notice of Proposed Rulemaking in November
2002 (available online at http://www.fda.gov/OHRMS/DOCKETS/98fr/110602c.htm
concerning possible changes to the animal feed rule.

Comprehensive information about FDA's work on BSE and links to other related
websites are available at http://www.fda.gov.

###

http://www.fda.gov/bbs/topics/news/2004/hhs_012604.html

For Immediate Release July 9, 2004 FSIS Press Office APHIS Press Office FDA
Media Relations

(202) 720-9113 (202) 734-7799 (301) 827-6242

USDA and HHS Strengthen Safeguards Against Bovine Spongiform Encephalopathy
WASHINGTON, July 9, 2004--HHS Secretary Tommy G. Thompson and Agriculture
Secretary Ann M. Veneman today announced three actions being taken to
further strengthen existing safeguards that protect consumers against the
agent that causes bovine spongiform encephalopathy (BSE, also known as "mad
cow disease").

The three documents on display today include:

A joint USDA Food Safety & Inspection Service (FSIS), USDA Animal and Plant
Health Inspection Service (APHIS) and Food and Drug Administration (FDA)
notice that asks for public comment on additional preventive actions that
are being considered concerning BSE; An interim final FDA rule that
prohibits the use of certain cattle-derived materials in human food
(including dietary supplements) and cosmetics; and A proposed FDA rule on
recordkeeping requirements for the interim final rule relating to this ban.
"Today's actions continue our strong commitment to public health protections
against BSE," Secretary Thompson said. "Although our current rules are
strong, when it comes to public health and safety we cannot be content with
the status quo. We must continue to make sure the public is protected to the
greatest extent possible."

"This Administration is committed to science-based measures to enhance and
protect public health," Veneman said. "The advance notice of proposed
rulemaking will allow the public the opportunity to provide their input."

"The series of firewalls already in place offer excellent protection against
BSE," said Acting Commissioner of the Food and Drug Administration, Dr.
Lester M. Crawford. "With these additional measures, we will make a strong
system even stronger by putting into effect the most comprehensive,
science-based improvements possible."

The steps already taken have been effective in protecting the American
consumer from exposure to BSE. Import controls on live cattle and certain
ruminant products were put in place more than 15 years ago. In 1997, FDA
finalized its animal feed ban, which has been the critical safeguard to stop
the spread of BSE through the U.S. cattle population by prohibiting the
feeding of most mammalian protein to cattle and other ruminant animals. USDA
implemented additional measures in January to ensure that no cattle tissues
known to be high risk for carrying the BSE agent are included in
USDA-regulated products. Finally, as became evident last December, there is
a contingency response plan, developed over the past several years, that is
launched immediately to contain any potential damage after a BSE positive
animal is found.

To allow interested parties and stakeholders the opportunity to comment on
the additional regulatory and policy measures under consideration, USDA's
APHIS and FSIS, along with the FDA, developed an advance notice of proposed
rulemaking that includes several additional actions the federal government
is considering regarding BSE.

The ANPR also provides the public a succinct report on the work of the
international review team (IRT) convened by Secretary Veneman to review the
U.S. response to the single case of BSE in the United States (in a cow
imported from Canada), along with a summary of the many actions already
taken by each agency on BSE.

USDA's FSIS continues to seek and address comments on actions taken in
relation to the BSE mitigation measures and put in place in January 2004.
FSIS is also specifically seeking 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.

USDA's APHIS is specifically seeking comments on the implementation of a
national animal identification system. In April, USDA announced the
availability of $18 million in Commodity Credit Corporation funding to
expedite development of a national animal identification system, which is
currently underway. APHIS is inviting comments on when and under what
circumstances the program should move from voluntary to mandatory, and which
species should be covered now and over the long term.

The ANPRM also requests comment on the following measures related to animal
feed, which is regulated by FDA:

removing specified risk materials (SRM's) from all animal feed, including
pet food, to control the risks of cross contamination throughout feed
manufacture and distribution and on the farm due to misfeeding; requiring
dedicated equipment or facilities for handling and storing feed and
ingredients during manufacturing and transportation, to prevent cross
contamination; prohibiting the use of all mammalian and poultry protein in
ruminant feed, to prevent cross contamination; and prohibiting materials
from non-ambulatory disabled cattle and dead stock from use in all animal
feed. FDA has reached a preliminary conclusion that it should propose to
remove SRM's from all animal feed and is currently working on a proposal to
accomplish this goal. Comments on these issues raised in the ANPRM are due
to FDA next month.

FDA today also issued an interim final rule that prohibits the use of
cattle-derived materials that can carry the BSE-infectious agent in human
foods, including certain meat-based products and dietary supplements, and in
cosmetics. These highÇrisk cattle-derived materials include SRM's that are
known to harbor concentrations of the infectious agent for BSE, such as the
brain, skull, eyes, and spinal cord of cattle 30 months of age or older, and
a portion of the small intestine and tonsils from all cattle, regardless of
their age. Prohibited high-risk bovine materials also include material from
non-ambulatory disabled cattle, the small intestine of all cattle, material
from cattle not inspected and passed for human consumption, and mechanically
separated beef.

This action is consistent with the recent interim final rule issued by USDA
declaring these materials to be inedible (unfit for human food) and
prohibiting their use as human food.

FDA's interim final rule, in conjunction with interim final rules issued by
FSIS in January 2004, will minimize human exposure to materials that
scientific studies have demonstrated are likely to contain the BSE agent
when derived from cattle that are infected with the disease. Consumption of
products contaminated with the agent that causes BSE is the likely cause of
a similar disease in people called variant Creutzfeldt-Jakob disease.

Although FDA's interim final rule has the full force and effect of law and
takes effect immediately upon publication in the Federal Register, FDA is
also asking for public comment on it.

In conjunction with the publication of the interim final rule, FDA is also
proposing to require that manufacturers and processors of FDA-regulated
human food and cosmetics containing cattle-derived material maintain records
showing that prohibited materials are not used in their products. FDA is
taking this action because records documenting the absence of such materials
are important to ensure compliance with requirements of the interim final
rule.

Publication of this USDA-FDA notice, as well as the two FDA documents, is
scheduled for mid-July in the Federal Register. Comments should be submitted
as directed in the addresses section of each document. Each document also
provides information about how and where comments received may be viewed.

####

Note to Reporters: USDA news releases, program announcements and media
advisories are available on the Internet. Go to the APHIS home page at
www.aphis.usda.gov and click on the "News" button.

HHS news releases are available online at www.hhs.gov; FDA news releases can
be found at www.fda.gov, which will also provide links to the documents
discussed in this release.

####

http://www.fda.gov/bbs/topics/news/2004/NEW01084.html

STATEMENT BY LESTER M. CRAWFORD, D.V.M., PH.D. DEPUTY COMMISSIONER OF FOOD
AND DRUGS DEPARTMENT OF HEALTH AND HUMAN SERVICES BEFORE THE COMMITTEE ON
AGRICULTURE, NUTRITION, AND FORESTRY UNITED STATES SENATE JANUARY 27, 2004

Introduction

Mr. Chairman, Members of the Committee, thank you for the opportunity to
participate in today’s hearing on measures taken by the Federal government
to safeguard human and animal health in the United States from Bovine
Spongiform Encephalopathy (BSE) and the response to the finding of a
BSE-positive cow in the State of Washington. I am Dr. Lester M. Crawford,
Deputy Commissioner, Food and Drug Administration (FDA or the Agency).

The mission of FDA is to protect the public health by assuring the safety
and efficacy of our nation’s human and veterinary drugs, human biological
products, medical devices, human and animal food supply, cosmetics, and
radiation emitting products. In fulfilling this mission, FDA is the Agency
responsible for assuring that all FDA-regulated products remain safe and
uncompromised from BSE and related diseases. Many FDA-regulated products
contain bovine ingredients, for example, heart valves, ophthalmic devices,
dental products, wound dressings, injectable drugs, vaccines, soups,
gravies, sausage casings, and animal feeds.

FDA has long been actively involved nationally and internationally in
efforts to understand and prevent the spread of BSE. FDA collaborates
extensively with the Centers for Disease Control and Prevention (CDC), the
National Institutes of Health (NIH), the Animal and Plant Health Inspection
Service (APHIS) and the Food Safety and Inspection Service (FSIS) within the
U.S. Department of Agriculture (USDA), Customs and Border Protection (CBP),
the Environmental Protection Agency (EPA), other Federal agencies, state and
local jurisdictions, and with affected industries and consumer groups. Many
of these activities fit within the framework of the Department of Health and
Human Service’s (HHS or the Department) Bovine Spongiform
Encephalopathy/Transmissible Spongiform Encephalopathy (BSE/TSE) Action
Plan, which was released in August 2001. This collaboration over many years
has enabled FDA to strengthen safeguards for FDA-regulated products and to
respond quickly and effectively to the first case of BSE within the U.S.

Executive Summary

The mission of the Agency is to protect the public health by assuring the
safety and efficacy of our nation’s human and veterinary drugs, human
biological products, medical devices, human and animal food supply,
cosmetics, and radiation emitting products. In fulfilling this mission, FDA
is the Agency responsible for assuring that all FDA-regulated products
remain safe and uncompromised from BSE and related diseases.

BSE is a progressive neurological disorder of cattle that results from
infection by an unconventional transmissible agent, and was first diagnosed
in the United Kingdom (U.K.) in 1986. Many FDA-regulated products contain
bovine ingredients, for example, heart valves, ophthalmic devices, dental
products, wound dressings, injectable drugs, vaccines, soups, gravies,
sausage casings, and animal feeds and thus must be taken into consideration
as part the effort to prevent infectivity by BSE.

FDA has a longstanding commitment to protecting consumers from BSE by
following multiple measures designed to safeguard FDA-regulated products
from possible contamination by the BSE agent. Under the Federal Food, Drug,
and Cosmetic (FD&C) Act, FDA has the authority to prevent the adulteration
and misbranding of FDA-regulated products. Further, for medical products
that require pre-market approval (e.g., drugs under Section 505 and medical
devices under Section 513 of the FD&C Act), FDA has addressed safety
concerns related to BSE through requirements of the application and approval
process.

The U.S. employs a robust multi-layered approach to preventing the
introduction and amplification of BSE. While the goal of this approach is to
achieve an extremely high level of compliance with each preventative
measure, this multi-layered approach is designed to protect the U.S.
consumer from exposure to the BSE infective material, and to date this
approach has been working. Since 1989, USDA has prohibited the importation
of live animals and animal products from BSE-positive countries. Since 1997,
FDA has prohibited the use of certain mammalian proteins in the manufacture
of ruminant feed. FDA continues to implement policies to keep safe all
FDA-regulated products, including food, food ingredients, dietary
supplements, drugs, vaccines, and cosmetics from risk of any
BSE-contaminated bovine material. As a result of these multiple regulatory
safeguards, the risk of exposure to BSE through products, FDA regulates
remains extremely low in the U.S.

FDA’s 1997 animal feed regulation forms the basis of the Agency’s efforts to
prevent the spread of BSE through animal feed. This rule prohibits the use
of most mammalian protein in the manufacture of animal feeds for ruminants.
FDA implemented this rule to establish in our country feeding practices
consistent with the best science and epidemiological knowledge known at the
time to prevent the spread of BSE throughout herds of U.S. cattle. A risk
assessment sponsored by USDA and conducted by the Harvard Center for Risk
Analysis, released in November 2001, identified FDA’s feed ban as one of the
primary safeguards against the spread of BSE in U.S. cattle.

To maximize protection afforded by the feed regulation, FDA has developed
and implemented a BSE/Ruminant Feed Ban Inspection compliance program and
established the goal of 100 percent compliance. FDA’s strategy for achieving
uniform compliance with the feed rule focuses on three areas: education,
inspection, and enforcement. FDA and its state counterparts conduct, at
least annually, targeted BSE inspections of 100 percent of known renderers,
protein blenders, and feed mills processing products containing material
prohibited from use in ruminant feed. Compliance by these establishments
with FDA’s feed rule is estimated to be at better than 99 percent. As of
December 20, 2003, FDA had received over 26,000 inspection reports (6,404
for Fiscal Year 2003). The majority of these inspections (around 70 percent)
were conducted by state officials for FDA, with the remainder conducted by
FDA officials. The total number of inspection reports represents 13,672
firms, 1,949 of which are active and handle materials prohibited from use in
ruminant feed. The 1,949 active firms that handle prohibited material have
been inspected by FDA and, as of December 31, 2003, only five were found to
have significant violations, resulting in official action indicated (OAI).
FDA is working with these firms to bring them into compliance.

On December 23, 2003, FDA was notified by USDA of a presumptive-positive
finding of BSE in a cow in Washington State. FDA immediately initiated its
BSE Emergency Response Plan. As part of the plan, FDA has been coordinately
closely with USDA so that we can effectively investigate this BSE case,
trace the various products involved, and take the appropriate steps to
protect the public. FDA investigators and inspectors located the high risk
material rendered from the infected cow, and the rendering plants placed a
hold on the rendered material, which is being disposed of appropriately. I
am happy to report that all of the establishments inspected by FDA during
the course of the investigation were in compliance with the feed ban. In
addition, to help address the concerns of foreign governments and restore
confidence in American products, FDA has participated, along with USDA, in
numerous meetings and consultations with foreign governments since USDA
surveillance found the BSE-positive cow.

In addition to new policies and regulations, new knowledge and tools gained
through applied research can greatly help us to be more effective in our
regulatory mission, such as protecting the country from BSE. Several of FDA’
s Centers, as well as many private laboratories, academic institutions, and
other Federal agencies (most notably NIH) are also involved in significant
research activities relating to TSEs. Basic areas requiring research
include: increasing our understanding of prions, learning how prions are
transmitted within a species and potentially between species, developing
diagnostic tests for humans and animals, developing detection methods for
use on regulated products, developing methods to increase or eliminate
infectivity, and designing new treatments. We are optimistic about the
promise of new technologies, such as better methods to quickly distinguish
the species of proteins and sensors to detect abnormal prions in food.
Development of these technologies can contribute significantly to the effort
to prevent the spread of BSE and must be considered carefully when
evaluating potential regulatory changes to address BSE.

At the time that FDA implemented the feed rule in 1997, the Agency also
recognized that evolving, complex scientific and public health issues,
particularly regarding BSE required the Agency to continue to assess and
scrutinize the rule to ensure its integrity as a firewall against the
potential for spread of BSE. To further explore ways the animal feed
regulation could be improved in November 2002, FDA published an advance
notice of proposed rulemaking (ANPR) soliciting information and views from
the affected industries and the public on some potential changes to its
current feed regulation, including ways that the animal feed regulation
could be strengthened. Although the risk of exposure to BSE in the U.S.
remains extremely low and the measures in place are working, as a result of
the recently discovered infected cow in the state of Washington, the Agency
is evaluating the appropriateness of additional science-based measures to
further strengthen our current protections.

Yesterday, Department Secretary Tommy Thompson and FDA Commissioner Mark
McClellan announced several additional public health measures to further
strengthen the current robust safeguards that help protect Americans from
exposure to the agent that causes BSE and help prevent the spread of BSE in
U.S. cattle. These measures relate to both protections for foods intended
for human consumption as well as additional measures to strengthen FDA’s
1997 final rule regulating animal feed. With respect to human foods, FDA
announced that it will extend to FDA-regulated foods, dietary supplements
and cosmetics, restrictions on using specified risk materials that would
complement the recent USDA announcements. Concerning animal feed, the Agency
announced a series of measures designed to lower even further the risk that
cattle will be purposefully or inadvertently fed “ruminant” proteins,
including, eliminating an exemption in the feed rule that allows mammalian
blood and blood products at slaughter to be fed to ruminants as a protein
source; banning the use of “poultry litter” as a feed ingredient for cattle
and other ruminants; prohibiting the use of “plate waste” as a feed
ingredient for ruminants, including cattle; and taking steps to further
minimize the possibility of cross-contamination of animal feed via
equipment, facilities or production lines.

Finally, FDA is increasing its inspections of feed mills and renderers in
2004. Our 2001 base funding for BSE-related activities was $3.8 million. We
shifted resources internally in 2001 and received a substantial increase
from Congress in 2002. Our funded level for 2004 is currently approximately
$21.5 million, almost a five-fold increase over the 2001 base. FDA will
itself conduct 2,800 inspections and will make its resources go even further
by working with state agencies to fund 3,100 contract inspections of feed
mills and renderers and other firms that handle animal feed and feed
ingredients. Through partnerships with states, FDA will also receive data on
700 additional inspections, for a total of 3,800 state contract and
partnership inspections in 2004. These inspections would include 100 percent
of all known renderers and feed mills that process products containing
prohibited materials.

The Agency looks forward to continuing to assist Congress as it evaluates
the risks associated with BSE, identifies opportunities to promote
technologies that will detect and prevent the spread of BSE, and considers
science-based approaches to further strengthen regulatory protections and
bolster the resources available to assist Federal, state, local and private
efforts to assure that BSE does not present a threat to human or animal
health in the U.S.

Background on Bovine Spongiform Encephalopathy (BSE)

BSE is a progressive neurological disorder of cattle that results from
infection by an unconventional transmissible agent, and was first diagnosed
in the U.K. in 1986. It belongs to a family of diseases, transmissible
spongiform encephalopathies (TSEs), a group of transmissible, slowly
progressive, degenerative diseases of the central nervous systems of several
species of animals.

The vast majority of BSE cases have been reported in the U.K., where more
than 183,000 cases in more than 35,000 herds have been reported through the
end of November 2003. The U.K.-BSE epidemic peaked in January 1993 at nearly
1,000 new cases per week. The original source of the BSE outbreak is
uncertain, but may have resulted from the feeding of scrapie-containing
sheep meat-and-bone meal to cattle. Scrapie is an endemic spongiform
encephalopathy and has been widespread in the U.K., where the rendered
carcasses of livestock (including sheep) were fed to ruminants and other
animals until 1988, as a protein-rich nutritional supplement. It appears
likely that changes in the rendering process in the U.K. that had taken
place around 1980 allowed the etiologic agent in infected carcasses to
survive, contaminate the protein supplement, and infect cattle. There is
strong evidence and widespread agreement that the outbreak was amplified by
feeding rendered bovine meat-and-bone meal to young calves. BSE has a
prolonged incubation period in cattle, ranging from two to eight years, with
a mean of five to six years.

Outside of the U.K., 22 other countries, mostly in Europe, have reported
cases of BSE in indigenous cattle to the World Organisation for Animal
Health (known as the O.I.E.). Other countries may be considered at risk
because of an inadequate surveillance program, a lack of information on
which to make a risk assessment, or the potential for exposure to BSE.

Related Diseases

TSEs also include “scrapie” in sheep and goats, “chronic wasting disease”
(CWD) in deer and elk, feline spongiform encephalopathy, transmissible mink
encephalopathy, and, in humans, kuru, Gerstmann-Straussler-Scheinker
syndrome, fatal familial insomnia, and Creutzfeldt-Jakob disease (CJD or
“classical” CJD) and variant CJD, which was first reported in the U.K. in
1996. TSEs are not known to infect non-mammalian species.

Classic CJD occurs throughout the world, including the U.S., at a rate of
about one case per million people. The median age at death in the U.S. of
patients with classic CJD is 68. Most cases of CJD are considered sporadic,
a small number are familial associated with a gene mutation, and a small
number are iatrogenic, resulting from the accidental transmission of the
causative agent via contaminated surgical equipment, or as a result of
cornea or dura mater transplants, or the administration of human-derived
pituitary growth hormones.

Variant CJD (vCJD) is a distinct variant from classic CJD and is strongly
believed to have been acquired from eating food products containing the BSE
agent. The absence of confirmed cases of vCJD in geographic areas free of
BSE supports this conclusion, and the interval between the period for
initial extended exposure of the population to potentially BSE-contaminated
food and the onset of initial vCJD cases, approximately ten years, is
consistent with known incubation periods for CJD. Experimental studies on
monkeys and mice, as well as additional laboratory studies of infecting
prions from vCJD patients and BSE-infected animals, also support such a
relationship. The incubation period for vCJD in humans is unknown, but is at
least five years and could extend up to 20 years or longer.

As of December 1, 2003, a total of 153 vCJD cases had been reported
worldwide, 143 of the cases occurring in the U.K. The low number of vCJD
cases relative to the number of cases of BSE in the U.K. indicates that a
substantial species barrier protects humans from widespread illness. There
are no cases of vCJD having been contracted in the U.S. The only person
diagnosed with vCJD while living in the U.S. is a U.K. citizen believed to
have acquired the disease while living in the U.K.

Legal and Regulatory Framework for FDA Protections

FDA has a longstanding commitment to protecting consumers from BSE by
following multiple measures designed to safeguard FDA-regulated products
from possible contamination by the BSE agent. Under the FD&C Act, FDA has
the authority to prevent the adulteration and misbranding of FDA-regulated
products. For example, FDA has used provisions in Section 402(a) (the food
adulteration provisions) and Section 403(a) (the food misbranding
provisions) of the FD&C Act to prohibit ruminant feed from containing
certain protein derived from mammalian tissues. These same adulteration and
misbranding provisions apply to human food. Further, for medical products
that require pre-market approval (e.g., drugs under Section 505 and medical
devices under Section 513 of the FD&C Act), FDA has addressed safety
concerns related to BSE through requirements of the application and approval
process. Additionally, when material from the one BSE-positive cow in the
U.S. was traced to renderers, FDA advised those firms that this material
could not be used as an animal feed because it was adulterated under Section
402(a)(5) of the FD&C Act because it was, in part, the product of a diseased
animal. Under section 801 of the FD&C Act, FDA may refuse admission of
imported food and certain other products that appear to be in violation of
the FD&C Act. Furthermore, under Section 701(a), FDA may promulgate
regulations for the efficient enforcement of the FD&C Act. For example,
under Section 701(a) and other sections, FDA promulgated its “animal feed”
rule (Title 21, Code of Federal Regulation (CFR) section 589.2000) to
prohibit ruminant feed from containing certain protein derived from
mammalian tissues. In addition, under the Public Health Service Act, FDA is
authorized to make and enforce regulations to prevent the introduction,
transmission, or spread of communicable diseases from foreign countries into
the U.S. or between states.

Preventing the Spread of BSE: FDA Protections

FDA and other Federal agencies have had preventive measures in place to
reduce the U.S. consumer’s risk of exposure to any BSE-contaminated meat and
food products for a considerable time. Since 1989, USDA has prohibited the
importation of live animals and animal products from BSE-at risk countries.
Since 1997, FDA has prohibited the use of certain mammalian proteins in the
manufacture of ruminant feed. FDA continues to implement policies to keep
safe all FDA-regulated products, including food, food ingredients, dietary
supplements, drugs, vaccines, and cosmetics from risk of any
BSE-contaminated bovine material. As a result of these multiple regulatory
safeguards, the risk of exposure to the BSE agent through products FDA
regulates remains extremely low in the U.S. In 1998, USDA commissioned the
Harvard Center for Risk Analysis to conduct an analysis and evaluation of
the U.S. regulatory measures to prevent the spread of BSE in the U.S. and to
reduce the potential exposure of U.S. consumers to BSE. The Harvard study
concluded, among other things, that even if introduced in the U.S., due to
the preventive measures currently in place in the U.S., BSE is extremely
unlikely to become established in the U.S.

The U.S. employs a robust approach to preventing the introduction and
amplification of BSE, and the prevention of introduction and amplification
of BSE has been described as consisting of five separate firewalls. Our
existing firewalls are based on a four-pronged regulatory strategy:

Our first firewall is formed through regulations and enforcement to protect
U.S. borders from potentially infective materials utilizing a regime of
import controls. USDA, beginning in 1989, enacted major restrictions on
imports, and more restrictive import controls have been introduced as we
have learned more about the science of BSE and as the worldwide epidemiology
has changed. FDA remains a committed partner with USDA and CBP in protecting
our borders. The second firewall is surveillance of the U.S. cattle
population for the presence of BSE. Surveillance of the cattle population is
the primary responsibility of USDA, and USDA has recently announced steps to
increase surveillance. The third firewall is prevention of the amplification
of BSE through feed provided to cattle and other ruminants, and this
responsibility falls primarily on FDA. FDA’s animal feed ban regulations
form the basis of this third firewall and have been cited as one of the most
significant elements needed to prevent the spread of BSE in the U.S. We have
taken intensive steps to get an extremely high level of compliance with this
feed ban. As a result, we have been able to work with the animal feed
industry to achieve more than a 99% compliance rate – and we intend to
continue to work for full compliance. The fourth firewall is making sure
that no bovine materials that can transmit BSE be consumed by people. So
even if a BSE-positive cow made it through all of the previous firewalls,
which is extremely unlikely, it would not pose any risk to people. USDA and
FDA have long had steps in place to help prevent any possible exposure to
BSE in bovine products, and recently USDA announced additional major steps
to prevent any of the tissues known to carry BSE from entering the beef
supply, as well as to restrict use of certain “downer” cows that might be at
higher risk of carrying BSE. FDA will be taking comparable measures to
prevent human exposure to the FDA-regulated bovine products that might
potentially harbor BSE. A fifth firewall is effective response planning to
contain the potential for any damage from a BSE positive animal, if one is
discovered at some point in the system. This urgent response plan went into
place immediately upon the discovery of a BSE-positive cow in Washington
State on December 23, 2003. We have inspected and traced products at 22
facilities, including feed mills, farms, dairy farms, calf feeder lots,
slaughterhouses, meat processors, transfer stations, and shipping terminals.
We have accounted for all the products related to the BSE-positive cow that
FDA regulates, and none have gone into human or animal consumption.
Moreover, FDA has conducted inspections at all the rendering facilities
involved, and found they were fully in compliance with our feed rule. The
goal of our firewall after firewall approach is to provide full protection
of the public against BSE without adding unnecessary costs or restricting
the consumption of safe beef products. FDA and USDA intend to maintain an
extremely high level of compliance with each firewall. In addition, our
multi-layered approach makes sure that even if each firewall doesn’t
function perfectly, the U.S. consumer is, nonetheless, protected from
exposure to the BSE infective material.

FDA’s Feed Rule: Substances Prohibited From Use in Animal Feed

Rendered feed ingredients contaminated with the BSE agent are believed to be
the principal means by which BSE is amplified in cattle populations. To help
prevent the establishment and spread of BSE through feed in the U.S., FDA
implemented a final rule that prohibits the use of most mammalian protein in
the manufacture of animal feeds for ruminants. This rule, 21 CFR 589.200,
became effective on August 4, 1997. Mammalian proteins exempted from the
rule are blood and blood products, gelatin, inspected meat products that
have been cooked and offered for human food and further heat processed for
feed (such as plate waste and used cellulosic food casings), milk products
(milk and milk proteins), and any product whose only mammalian protein
consists entirely of porcine or equine protein. Fats and oils, such as
tallow, do not fall within the current feed rule because they are not
protein.

FDA implemented this rule to establish in our country feeding practices
consistent with the best science and epidemiological knowledge known at the
time to prevent the spread of BSE throughout herds of U.S. cattle. A risk
assessment sponsored by USDA and conducted by the Harvard Center for Risk
Analysis, released in November 2001, identified FDA’s feed ban as one of the
primary safeguards against the spread of BSE in U.S. cattle.

To maximize protection afforded by the feed regulation, FDA has developed
and implemented a BSE/Ruminant Feed Ban Inspection compliance program and
established the goal of 100 percent compliance. FDA’s strategy for achieving
uniform compliance with the feed rule focuses on three areas: education,
inspection, and enforcement.

A strong inspection presence can be considered the backbone of FDA’s
strategy for achieving compliance with the feed rule. FDA and its state
counterparts conduct, at least annually, targeted BSE inspections of 100
percent of known renderers, protein blenders, and feed mills processing
products containing material prohibited from use in ruminant feed.
Compliance by these establishments with FDA’s 1997 feed rule is over 99
percent. FDA has prioritized the inspection process so that any firms found
to be out of compliance in their last inspection will be promptly
re-inspected. In addition, FDA will conduct for-cause inspections where
evidence dictates, e.g., as a result of a sampling assignment. FDA and the
states also conduct inspections of selected processors that are not using
prohibited material to ensure compliance with the regulation by this segment
of the industry.

Inspections conducted by FDA or state investigators are classified to
reflect the compliance status at the time of the inspection based upon the
objectionable conditions documented. These inspection decisions are reported
as OAI, Voluntary Action Indicated (VAI), or No Action Indicated (NAI).

An OAI inspection classification occurs when significant objectionable
conditions or practices were found and regulatory sanctions are warranted in
order to address the establishment’s lack of compliance with the regulation.
An example of an OAI inspection classification would be findings of
manufacturing procedures insufficient to ensure that ruminant feed is not
contaminated with prohibited material. Inspections classified with OAI
violations will be promptly re-inspected following the regulatory sanctions
to determine whether adequate corrective actions have been implemented. A
VAI inspection classification occurs when objectionable conditions or
practices were found that do not meet the threshold of regulatory
significance, but do warrant advisory actions to inform the establishment of
findings that should be voluntarily corrected. Inspections classified with
VAI violations are more technical violations of the ruminant feed rule such
as minor record-keeping lapses and conditions involving non-ruminant feeds.
A NAI inspection classification occurs when no objectionable conditions or
practices were found during the inspection or the significance of the
documented objectionable conditions found does not justify further actions.
As of December 20, 2003, FDA had received over 26,000 inspection reports
(6,404 for fiscal year 2003). The majority of these inspections (around 70
percent) were conducted by state officials for FDA, with the remainder
conducted by FDA officials. The total number of inspection reports
represents 13,672 firms, 1,949 of which are active and handle materials
prohibited from use in ruminant feed. These firms, which may be in more than
one category, include renderers, licensed feed mills, feed mills not
licensed by FDA, protein blenders, and others (such as ruminant feeders,
on-farm mixers, pet food manufacturers, animal feed salvagers, distributors,
retailers, and animal feed transporters). The 1,949 active firms that handle
prohibited material have been inspected by FDA and, as of December 31, 2003,
only five were found to have significant violations, resulting in OAI. FDA
is working with these firms to bring them into compliance.

To be transparent about inspection results, FDA has recorded inspectional
findings in a newly designed FDA BSE/Ruminant Feed Inspection Database
available on FDA’s website. The database is dynamic, with new information
being entered on a continual basis. Each entry in the database represents
the results of the most recent inspection.

FDA also conducts sampling of feed and feed ingredients in the marketplace
as an additional tool to target firms for inspection. This type of sample
analysis is being done using feed microscopy as the method for detecting
prohibited materials. Other methods, such as polymerase chain reaction
(PCR), are being validated for additional analytical use.

Enforcement is an important component of the compliance strategy. FDA
pursues enforcement actions when we find knowing or intentional
non-compliance, or if repeated inspection and educational efforts are
ineffective in assuring compliance. Our first action of choice will
ordinarily be a Warning Letter, which notifies responsible parties of a
violation or violations and asks for a response within a certain time frame
explaining corrective actions taken. When it is consistent with the public
protection responsibilities of FDA and the nature of the violation, it is
our practice to afford individuals and firms an opportunity voluntarily to
take appropriate and prompt corrective action. The Agency has additional,
more stringent enforcement tools available when our notification to the
company of documented violations does not lead to compliance with the FD&C
Act, including product seizure, injunction, and prosecution.

As of January 1, 2004, FDA has issued 63 Warning Letters and has one court
ordered Permanent Injunction since the BSE feed rule went into effect. Also,
47 firms recalled 280 products during the same time period; 12 of the
recalls were in 2003.

Education has been, and continues to be, a critical component of our
compliance strategy. Providing clear guidance and information on FDA’s
requirements and regulations is vital to help assure compliance. FDA has
provided and sponsored many educational services and forums, including
nationwide seminars, CD-ROM training, teleconferences, guidances targeted
for different segments of the animal feed industry, guidance for Federal and
state inspectors, and a variety of published articles. The Agency has met
with many industry trade groups to discuss coordination of educational
efforts with affected parties, and we expect to continue an open dialogue,
seeking suggestions for types of educational approaches, sharing resources,
and keeping the industry updated on new developments or problem areas that
arise.

Import Controls

To minimize the risk of the introduction or spread of BSE we also must have
strong enforcement measures to protect our borders. FDA’s Import Program is
responsible for coordinating the import of products potentially infected
with or at high risk of infection with the agent associated with BSE.
Operationally, FDA’s Import Program provides for the review of information
about FDA-regulated products offered for entry into the U.S. and the
opportunity for physical examination of the products. FDA uses this
information to determine whether a product is subject to refusal of
admission.

In protecting the borders from potentially unsafe products, FDA works
closely with USDA and CBP to ensure a coordinated and efficient BSE import
control strategy. This tri-agency cooperative effort has led to a
multi-layer review process whereby each agency utilizes the strengths of its
particular entry procedures to produce a composite system that is
considerably more robust than any one component. BSE import activities are
reviewed and coordinated by an inter-agency workgroup composed of
representatives from FDA, CBP, and USDA/APHIS. In fact, on February 5, 2002,
with APHIS, FSIS, Canadian Food Inspection Agency (CFIA), Health Canada, and
state participation, FDA conducted a simulation exercise involving the
importation of potentially BSE-contaminated product and subsequent
regulatory follow-up.

FDA uses Import Alerts to disseminate information regarding problems or
potential problems with imported products. Import Alerts recommend that
field offices examine, sample, or detain and, if warranted, refuse admission
of the product in question. These Import Alerts are made available on FDA’s
website. With respect to its import alerts on BSE, FDA coordinates closely
with APHIS and its prohibitions on the importation of products related to
BSE concerns. An alert may cover an individual manufacturer, supplier, or a
particular product from an entire country. Import Alerts also may be issued
as a follow-up to an inspection, when it is determined that a manufacturer
is in violation of good manufacturing practice requirements.

FDA has in place several import alerts targeting BSE. Import Alert 17-04,
first issued in October 1994, allows detention, without physical
examination, of bulk shipments of high-risk bovine tissues and
tissue-derived ingredients from BSE-at-risk countries. Import Alert 99-25,
first issued in January 2001, allows detention without physical examination
of animal feed, animal feed ingredients, and other products for animal use
from countries identified by USDA as BSE-positive or BSE-at-risk when
processed animal protein is declared in the ingredients or when FDA sampling
and analysis finds the presence of undeclared animal protein. Import Alert
71-02, issued in October 2003, calls for detention without physical
examination of products of specific firms located in USDA-listed
BSE-positive or BSE-at-risk countries, which have been identified through
FDA sampling and analysis, as importing products containing animal protein.
These import alerts are continuously updated as new countries are listed by
USDA as either BSE-positive or BSE-at-risk, or to make other appropriate
changes.

FDA’s Response to the Identification of a BSE-Positive Cow in Washington
State

On December 23, 2003, at approximately 3:00 pm, the Agency’s Office of
Crisis Management (OCM) was notified by USDA’s APHIS of a
presumptive-positive finding of bovine spongiform encephalopathy (BSE) in a
“downer” cow slaughtered on December 9, 2003, at a USDA-inspected slaughter
facility in Washington State.

FDA had in place its Bovine Spongiform Encephalopathy Emergency Response
Plan that describes the roles and activities of each of the Agency
components involved in managing this kind of emergency. This plan had been
tested several times in tabletop and simulated incidents that actively
involved state, Federal, and Canadian counterparts. The plan has been in
place since 2001 and has been revised in response to the incident exercises
conducted by FDA.

As provided in the Emergency Response Plan, OCM’s Emergency Operations
Center (EOC) is the single point of coordination for FDA’s response to a BSE
emergency. FDA’s EOC maintains contact with HHS Secretary’s Command Center
(SCC), CDC’s EOC, USDA/FSIS Office of Food Security and Emergency
Preparedness, and other EOCs, as appropriate.

At the time of notification by USDA of the presumptive case of BSE, FDA’s
OCM initiated its BSE Emergency Response Plan and activated FDA’s EOC.
Various FDA headquarters and FDA center offices were immediately notified in
accordance with the plan, as well as the FDA Seattle District Office
(SEA-DO).

FDA responsibilities include conducting inspections and investigations to
determine where any animal by-products went and ensuring that they did not
enter commerce contrary to provisions of the FD&C Act and other statutes
enforced by FDA.

On the same day FDA was notified of the presumptive case of BSE by USDA, FDA
’s SEA-DO dispatched five investigative teams to investigate various
facilities suspected of being either a source or recipient of affected
material.

An aggressive schedule of inspections and investigations was pursued by FDA
which enabled FDA to announce in Decembe
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