[Federal Register Volume 69, Number 134 (Wednesday, July 14, 2004)]
[Proposed Rules]
[Pages 42287-42300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-15882]



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Part III





Department of Agriculture





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Animal and Plant Health Inspection Service



9 CFR Parts 50, 51, et al.



Food Safety and Inspection Service

9 CFR Parts 309, 310, 311, 318, and 319



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Department of Health and Human Services





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Food and Drug Administration

21 CFR Part 589



Federal Measures To Mitigate BSE Risks: Considerations for Further 
Action; Proposed Rule

Federal Register / Vol. 69, No. 134 / Wednesday, July 14, 2004 / 
Proposed Rules

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 
64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 
81, 82, 83, 84, and 85

[Docket No. 04-047-1]
RIN 0579-AB86

Food Safety and Inspection Service

9 CFR Parts 309, 310, 311, 318, and 319

[Docket No. 04-021ANPR]
RIN 0583-AC88

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 589

[Docket No. 2004N-0264]
RIN 0910-AF46


Federal Measures To Mitigate BSE Risks: Considerations for 
Further Action

AGENCIES: Animal and Plant Health Inspection Service and Food Safety 
and Inspection Service, USDA; and Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking; invitation to comment.

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SUMMARY: Following detection of bovine spongiform encephalopathy (BSE) 
in an imported dairy cow in Washington State in December 2003, the 
Secretaries of the U.S. Departments of Agriculture and Health and Human 
Services announced a series of regulatory actions and policy changes to 
strengthen protections against the spread of BSE in U.S. cattle and 
against human exposure to the BSE agent. The Secretary of Agriculture 
also convened an international panel of experts on BSE to review the 
U.S. response to the Washington case and make recommendations that 
could provide meaningful additional public or animal health benefits. 
The purpose of this advance notice of proposed rulemaking is to inform 
the public about the panel's recommendations and to solicit comment on 
additional measures under consideration based on those recommendations 
and other considerations.

DATES: APHIS and FSIS will consider all comments received on or before 
September 13, 2004. FDA will consider all comments received on or 
before August 13, 2004.

ADDRESSES:
    You may submit comments to APHIS by any of the following methods:
     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Docket No. 04-047-1, 
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your 
comment refers to Docket No. 04-047-1.
     E-mail: Address your comment to 
[email protected]. Your comment must be contained in the body 
of your message; do not send attached files. Please include your name 
and address in your message and ``Docket No. 04-047-1'' on the subject 
line.
     Agency Web Site: Go to http://www.aphis.usda.gov/ppd/rad/cominst.html for a form you can use to submit an e-mail comment through 
the APHIS web site.
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the instructions for locating this 
docket and submitting comments.
    Reading Room: You may read any comments that we receive on this 
docket in our reading room. The reading room is located in room 1141 of 
the USDA South Building, 14th Street and Independence Avenue SW., 
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., 
Monday through Friday, except holidays. To be sure someone is there to 
help you, please call (202) 690-2817 before coming.
    Other Information: You may view APHIS documents published in the 
Federal Register and related information, including the names of groups 
and individuals who have commented on APHIS dockets, on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
    You may submit comments to FSIS by any of the following methods:
     Mail, including floppy disks or CD-ROM's, and hand-or 
courier-delivered items: Send to Docket Clerk, U.S. Department of 
Agriculture, Food Safety and Inspection Service, 300 12th Street, SW., 
Room 102 Cotton Annex, Washington, DC 20250.
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions at that site for 
submitting comments.
    Instructions: All submissions received must include the Agency name 
and Docket No. 04-021ANPR.
    Other information: All comments submitted in response to this 
advance notice of proposed rulemaking, as well as research and 
background information used by FSIS in developing this document, will 
be available for public inspection in the FSIS Docket Room at the 
address listed above between 8:30 a.m. and 4:30 p.m., Monday through 
Friday. The comments also will be posted on the Agency's Web site at 
http://www.fsis.usda.gov/OPPDE/rdad/FRDockets.htm.
    You may submit comments to FDA by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency web site: http://www.fda.gov/dockets/comments. 
Follow the instructions for submitting comments.
     E-mail: [email protected]. Include Docket No. 2004N-
0264 or Regulatory Identification No. (RIN) 0910-AF46 in the subject 
line of your e-mail message.
     Fax: (301) 827-6870.
     Mail/hand delivery/courier (for paper, disc, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions must include the Agency name and 
Docket No. 2004N-0264 or Regulatory Identification No. (RIN) 0910-AF46.
    Other information: All comments received, including any personal 
information provided, will be posted without change to http://www.fda.gov/dockets/ecomments, For access to the docket to read 
background documents or comments received, go to http://www.fda.gov/dockets/ecomments or the Division of Dockets Management, 5630 Fishers 
Lane, rm. 1061, Rockville, MD. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

FOR FURTHER INFORMATION CONTACT: APHIS: Dr. Anne Goodman, Supervisory 
Staff Officer, Regionalization Evaluation Services, National Center for 
Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 
20737-1231; (301) 734-4356.
    FSIS: Daniel L. Engeljohn, Ph.D., Deputy Assistant Administrator, 
Office of Policy, Program, and Education Development, Food Safety and 
Inspection Service, U.S. Department of Agriculture, Washington, DC 
20250-3700, Telephone (202) 205-0495, Fax (202) 401-1760. Copies of 
references cited in this document are available in the FSIS Docket 
Clerk's Office (see ADDRESSES).
    FDA: Burt Pritchett, D.V.M., Center for Veterinary Medicine (HFV-
220), Food and Drug Administration, 7500

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Standish Pl., Rockville, MD 20855, 301-827-0177, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Purpose

    Bovine spongiform encephalopathy (BSE), widely referred to as ``mad 
cow disease,'' is a progressive and fatal neurological disorder of 
cattle. The disease was first diagnosed in 1986 in the United Kingdom, 
but had never been detected in a native animal in North America until 
May 2003 when it was diagnosed in a single dairy cow in Canada. 
Subsequently, in December 2003, BSE was diagnosed in a single dairy cow 
in Washington State that had been imported from Canada. Variant 
Creutzfeld-Jakob disease, a chronic and fatal neurodegenerative disease 
that affects humans, has been linked to the consumption of beef 
products contaminated with the BSE agent. The U.S. Government--
specifically, the U.S. Department of Health and Human Services (HHS) 
and the U.S. Department of Agriculture (USDA)--has implemented a number 
of measures to protect the public from health risks associated with BSE 
and to prevent the spread of the disease in U.S. cattle. The agencies 
are currently considering additional safeguards based on the 
recommendations of an international review team convened by the 
Secretary of Agriculture and on other considerations. The purpose of 
this advance notice of proposed rulemaking (ANPRM) is to inform the 
public about the report and recommendations of the international review 
team and to solicit public comment on the additional measures under 
consideration.

II. Background

A. Bovine Spongiform Encephalopathy

    BSE belongs to the family of diseases known as transmissible 
spongiform encephalopathies (TSEs). In addition to BSE, TSEs include, 
among other diseases, scrapie in sheep and goats, chronic wasting 
disease (CWD) in deer and elk, and Creutzfeldt-Jakob disease (CJD) in 
humans. The agent that causes BSE and other TSEs has yet to be fully 
characterized. The theory that is most accepted in the scientific 
community is that the agent is a prion, which is an abnormal form of a 
normal protein known as cellular prion protein, although other agents 
have also been implicated. There is currently no test to detect the 
disease in a live animal. BSE is confirmed by postmortem microscopic 
examination of an animal's brain tissue or by detection of the abnormal 
form of the prion protein in an animal's tissues. The pathogenic form 
of the protein is both less soluble and more resistant to degradation 
than the normal form. The BSE agent is extremely resistant to heat and 
to normal sterilization processes. It does not evoke any demonstrated 
immune response or inflammatory reaction in host animals.
    Since November 1986, there have been more than 180,000 confirmed 
cases of BSE in cattle worldwide. The disease has been confirmed in 
native-born cattle in 22 European countries in addition to the United 
Kingdom, and in some non-European countries, including Japan, Israel, 
and Canada. Over 95 percent of all BSE cases have occurred in the 
United Kingdom, where the epidemic peaked in 1992/1993, with 
approximately 1,000 new cases in cattle reported per week. Agricultural 
officials in the United Kingdom have taken a series of actions to 
eliminate BSE, including making it a reportable disease, banning 
mammalian meat-and-bone meal in feed for all food-producing animals, 
prohibiting the inclusion of animals more than 30 months of age in the 
animal and human food chains, and destroying all animals showing signs 
of BSE and other potentially exposed animals at high risk of developing 
the disease. As a result of these actions, most notably the feed bans, 
the rate of newly reported cases of BSE in the United Kingdom has 
decreased sharply and continues a downward trend.
    In 1996, a newly recognized form of the human disease CJD, referred 
to as variant CJD (vCJD), was reported in the United Kingdom. 
Scientific and epidemiological studies have linked vCJD to exposure to 
the BSE agent, most likely through human consumption of cattle products 
contaminated with the agent that causes BSE. To date, approximately 150 
probable and confirmed cases of vCJD have been reported in the United 
Kingdom, where there had been a high level of consumption of 
contaminated cattle product. In the United States, where measures to 
prevent the introduction and spread of BSE have been in place for some 
time, there is far less potential for human exposure to the BSE agent. 
The Centers for Disease Control and Prevention (CDC) leads a 
surveillance system for vCJD in the United States, and as of December 
2003, had not detected vCJD in any resident of the United States that 
had not lived in or traveled to the United Kingdom for extended periods 
of time. In 2002, a probable case of vCJD was reported in a Florida 
resident who had lived in the United Kingdom during the BSE epidemic. 
Epidemiological data indicate that the patient likely was exposed to 
the BSE agent before moving to the United States.

B. Prevention of BSE in the United States

    The United States Government has implemented a number of measures 
since 1989 to prevent BSE from entering the United States and to 
prevent the spread of the disease should it be introduced into the 
United States.
Import Restrictions and 1997 Feed Ban
    Since 1989, USDA's Animal and Plant Health Inspection Service 
(APHIS) has prohibited the importation of live cattle and other 
ruminants and certain ruminant products, including most rendered 
protein products, into the United States from countries where BSE is 
known to exist. In 1997, due to concerns about widespread risk factors 
and inadequate surveillance for BSE in many European countries, APHIS 
extended importation restrictions on ruminants and ruminant products to 
all of the countries in Europe.
    Also in 1997, HHS' Food and Drug Administration (FDA) prohibited 
the use of all mammalian protein, with the exception of pure pork and 
pure equine protein from single species processing plants, in animal 
feeds given to cattle and other ruminants (62 FR 30936; June 5, 1997; 
codified at 21 CFR 589.2000). The rule allows exceptions for certain 
products believed at the time to present a low risk of transmitting 
BSE: 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, 
referred to below as ``plate waste''); and milk products (milk and milk 
protein). Firms must keep specified records on the manufacture of feed, 
have processes in place to prevent commingling of ruminant and 
nonruminant feed containing prohibited materials, and ensure that 
nonruminant feed containing materials prohibited in ruminant feed is 
labeled conspicuously with the statement, ``Do not feed to cattle or 
other ruminants.''
    In December 2000, APHIS expanded its prohibitions on imports of 
rendered ruminant protein products from BSE-restricted regions to 
include rendered protein products of any animal species because of 
concern that cattle feed supposedly free of ruminant protein may have 
been cross contaminated with the BSE agent. FDA also issued import 
alerts on animal feed ingredients for APHIS-listed countries.

[[Page 42290]]

Animal Surveillance Program and Emergency Response Plan
    The United States has had an active surveillance program for BSE 
since 1990. Historically, the sampling strategy was designed to detect 
one BSE-infected animal per million cattle and to take into account 
regional differences while striving for uniform surveillance throughout 
the country. Since 1993, BSE surveillance in the United States has met 
or exceeded international standards as outlined in the Terrestrial 
Animal Health Code of the Office International des Epizooties (OIE), 
the world organization for animal health. For additional details on BSE 
surveillance since 1990, see http://www.aphis.usda.gov/lpa/issues/bse/bse-surveillance.html.
    Since its inception, animal surveillance for BSE in the United 
States has been designed to sample those cattle in which BSE is most 
likely to occur and in which the disease would most likely be detected. 
The targeted surveillance population has, therefore, included adult 
cattle displaying clinical signs that could be considered to be 
consistent with BSE. This includes cattle exhibiting signs of central 
nervous system (CNS) abnormalities, cattle that are non-ambulatory, 
cattle that have died on the farm from unexplained causes, and cattle 
that display other clinical signs that could be compatible with BSE. 
The BSE surveillance program has historically not included apparently 
healthy cattle presented for routine slaughter because that is not the 
population where the disease would most likely be detected.
    Further, APHIS, in cooperation with USDA's Food Safety and 
Inspection Service (FSIS), prepared an emergency response plan to be 
used in the event that BSE is identified in the United States (http://www.aphis.usda.gov/lpa/issues/bse/bsesum.pdf). FDA and other Federal 
agencies have also developed contingency plans that would operate in 
association with the USDA plan. USDA and HHS have held various outreach 
and tabletop exercises to test various components of their contingency 
plans.

C. Risk of BSE in the United States

    In April 1998, USDA contracted with the Harvard Center for Risk 
Analysis (HCRA) at Harvard University and the Center for Computational 
Epidemiology at Tuskegee University to conduct a comprehensive 
investigation of BSE risk in the United States. The report,\1\ widely 
referred to as the Harvard Risk Assessment or the Harvard Study, is 
referred to in this document as the Harvard-Tuskegee Study. It was 
completed in 2001 and released by the USDA. Following a peer review of 
the Harvard-Tuskegee Study in 2002, the authors responded to the peer 
review comments and released a revised risk assessment in 2003.\2\
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    \1\ Harvard Center for Risk Analysis, Harvard School of Public 
Health, and Center for Computational Epidemiology, College of 
Veterinary Medicine, Tuskegee University, ``Evaluation of the 
Potential for Bovine Spongiform Encephalopathy in the United 
States,'' http://www.aphis.usda.gov/lpa/issues/bse/risk_assessment/mainreporttext.pdf, 2001.
    \2\ Research Triangle Institute, ``Review of the Evaluation of 
the Potential for Bovine Spongiform Encephalopathy in the United 
States,'' accessed online at http://www.aphis.usda.gov/lpa/issues/bse/BSE_Peer_Review.pdf, 2002. Harvard Center for Risk Analysis, 
Harvard School of Public Health, ``Evaluation of the Potential for 
Bovine Spongiform Encephalopathy in the United States: Response to 
Reviewer Comments Submitted by Research Triangle Institute,'' http://www.aphis.usda.gov/lpa/issues/bse/ResponsetoComments.pdf, 2003. 
Harvard Center for Risk Analysis, Harvard School of Public Health, 
and Center for Computational Epidemiology, College of Veterinary 
Medicine, Tuskegee University, ``Evaluation of the Potential for 
Bovine Spongiform Encephalopathy in the United States,'' http://www.aphis.usda.gov/lpa/issues/bse/madcow.pdf, 2003.
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    The Harvard-Tuskegee Study 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 assessment concluded that the United States is 
highly resistant to any proliferation of BSE or similar disease and 
that measures taken by the U.S. Government and industry make the United 
States robust against the spread of BSE to animals or humans should it 
be introduced into this country.
    The Harvard-Tuskegee Study concluded that the most effective 
measures for reducing potential introduction and spread of BSE are: (1) 
The ban placed by APHIS on the importation of live ruminants and 
ruminant meat-and-bone meal from the United Kingdom since 1989 and all 
of Europe since 1997; and (2) the feed ban instituted in 1997 by FDA to 
prevent recycling of potentially infectious cattle tissue. The Harvard-
Tuskegee Study further indicated that, if introduction of BSE had 
occurred via importation of live animals from the United Kingdom prior 
to 1989, mitigation measures already in place would have minimized 
exposure and begun to eliminate the disease from the cattle population.
    The Harvard-Tuskegee Study also identified three pathways or 
practices that could facilitate human exposure to the BSE agent or the 
spread of BSE should it be introduced into the United States: (1) Non-
compliance with FDA's ruminant feed regulations prohibiting the use of 
certain proteins in feed for cattle and other ruminants; (2) rendering 
of animals that die on the farm and use (through illegal diversion or 
cross contamination) of the rendered product in ruminant feed; and (3) 
the inclusion of high-risk tissues from cattle, such as brain and 
spinal cord, in products for human consumption. The Harvard-Tuskegee 
Study's independent evaluation of the potential risk mitigation 
measures predicts that a prohibition against rendering of animals that 
die on the farm would reduce the potential cases of BSE in cattle 
following hypothetical exposure by 82 percent as compared to the base 
case scenario,\3\ and that a ban on specified risk materials (SRMs) 
\4\, including brain, spinal cord and vertebral column, from inclusion 
in human and animal food would reduce potential BSE cases in cattle by 
88 percent and potential human exposure to BSE by 95 percent as 
compared to the base case scenario.
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    \3\ Harvard Center for Risk Analysis, Harvard School of Public 
Health, and Center for Computational Epidemiology, College of 
Veterinary Medicine, Tuskegee University, ``Evaluation of the 
Potential for Bovine Spongiform Encephalopathy in the United 
States,'' section 3, ``Simulation Model and Base Case Assumptions,'' 
http://www.aphis.usda.gov/Ipa/issues/bse/risk_assessment/mainreporttext.pdf, 2001.
    Harvard Center for Risk Analysis, Harvard School of Public 
Health, and Center for Computational Epidemiology, College of 
Veterinary Medicine, Tuskegee University, ``Evaluation of the 
Potential for Bovine Spongiform Encephalopathy in the United 
States,'' http://www.aphis.usda.gov/lpa/issues/bse/madcow.pdf, 2003.
    \4\ Specified risk materials (SRMs) are ruminant tissues that 
have demonstrated infectivity at some point during the BSE 
incubation period.
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    In 2003, following the identification of BSE in a native-born cow 
in Canada, the HCRA evaluated the implications of a then hypothetical 
introduction of BSE into the United States \5\, using the same 
simulation model developed for the initial Harvard-Tuskegee Study. This 
assessment confirmed the conclusions of the earlier study--namely, that 
the United States presents a very low risk of establishing or spreading 
BSE should it be introduced.
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    \5\ Harvard Center for Risk Analysis, Harvard School of Public 
Health, ``Evaluation of the Potential Spread of BSE in Cattle and 
Possible Human Exposure Following Introduction of Infectivity into 
the United States from Canada,'' accessed online at http://www.aphis.usda.gov/lpa/issues/bse/harvard_10-3/text_wrefs.pdf, 
2003.
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    In May 2004, USDA contracted with the HCRA to revise and update the 
BSE risk assessment model to reflect recent events that have occurred 
in the United States. These recent events include such increased risk 
mitigation measures as the prohibition of SRMs in human food.

[[Page 42291]]

In addition, USDA requested that the HCRA specifically analyze the 
recommendations of the international review team to determine whether 
the recommendations would provide significant differences in risk 
mitigation levels. While this information will be valuable as we 
analyze any future actions concerning domestic policy changes, the 
existing Harvard-Tuskegee model demonstrates that, with the safeguards 
in place--even before the case of BSE was detected in Washington State 
in December 2003--the risk of spread of BSE from any introduction was 
very low, due largely to import restrictions and the 1997 feed ban. 
Because control measures have been increased and strengthened since 
that time, it is anticipated that any changes to the model reflecting 
additional control measures would continue to demonstrate a further 
decrease in risk of spread.

III. The Case in Washington State and U.S. Actions in Response

    On December 23, 2003, USDA announced a presumptive positive case of 
BSE in a dairy cow in Washington State. Samples had been taken from the 
cow on December 9 as part of USDA's BSE surveillance program. The BSE 
diagnosis was made on December 22 and 23 by histopathology and 
immunohistochemical testing at the National Veterinary Services 
Laboratories in Ames, IA, and verified on December 25 by the 
international reference laboratory, the Veterinary Laboratories Agency 
in Weybridge, England. This case followed the identification of BSE in 
a single cow in Alberta, Canada, in May 2003.

A. The Epidemiological Investigation and Related Activities

    Upon detection of the BSE-positive cow in Washington State, USDA, 
FDA and other Federal and State agencies immediately began working 
together closely to perform a full epidemiological investigation \6\, 
trace any potentially infected cattle, trace potentially contaminated 
rendered product, increase BSE surveillance, and take additional 
measures to address human and animal health.
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    \6\ A report of the epidemiological investigation, ``A Case of 
Bovine Spongiform Encephalopathy (BSE) in the United States,'' was 
issued in March 2004 and is available at http://www.aphis.usda.gov/lpa/issues/bse/BSE_tr_ban%20_ltr_enc_1.pdf.
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    The epidemiological investigation and DNA test results confirm that 
the infected cow was not indigenous to the United States, but rather 
was born and most likely became infected in Alberta, Canada, prior to 
Canada's 1997 implementation of a ban on feeding mammalian protein to 
ruminants.
    The infected cow entered the United States on September 4, 2001, as 
part of a shipment of 81 animals from the source herd in Canada. Of 
these 81 animals, 25 were determined, as a result of the 
epidemiological investigation, to be higher risk as defined by the OIE. 
A higher risk animal is one born on premises known to be a source of an 
infected animal within 12 months before or after the birth of the 
infected cow.
    Counting the infected cow, USDA definitively accounted for 14 of 
the 25 animals considered to be higher risk, along with 15 others from 
the source herd that were in the initial shipment, plus 7 additional 
animals dispersed from the birth herd. The number of animals found--35 
in addition to the infected cow--is consistent with the number expected 
after analysis of regional culling rates.
    In addition to those animals, another 220 cattle were culled from 
10 premises on which one or more source herd animals were found. These 
cattle were culled because they could possibly have been from the 
Canadian source herd. Out of an abundance of caution, all 255 animals 
were euthanized and tested for BSE; all of the animals tested negative. 
Because there is a small probability that BSE can be transmitted 
maternally, the two live offspring of the infected cow were also 
euthanized. A third had died at birth in October 2001. All carcasses 
were properly disposed of in accordance with Federal, State, and local 
regulations.
    In conjunction with USDA's investigation, FDA conducted an 
extensive feed investigation. By December 27, 2003, FDA had located all 
potentially infectious product rendered from the BSE-positive cow in 
Washington State. The product was disposed of in a landfill in 
accordance with Federal, State, and local regulations.
    The United States concluded the active investigation and culling 
activities related to the one infected cow on February 9, 2004, and 
redirected resources toward planning, implementing, and enforcing 
national policy measures to promote BSE surveillance and protect human 
and animal health.

B. International Review Team Convened

    Prior to the conclusion of the epidemiological investigation, on 
January 22-24, 2004, the Secretary of Agriculture convened an 
international panel of experts to assess the epidemiological 
investigation, provide expert opinion as to when the active phase 
should be terminated, consider the response actions of the United 
States to date, and provide recommendations as to actions that could be 
taken to provide additional meaningful human or animal health benefits 
in light of the North American experience.
    The international review team was organized as a subcommittee of 
the Secretary of Agriculture's Foreign Animal and Poultry Disease 
Advisory Committee. The subcommittee consisted of Prof. U. Kihm 
(Switzerland), Prof. W. Hueston (USA), Dr. D. Matthews (UK), Prof. S. 
C. MacDiarmid (New Zealand), and Dr. D. Heim (Switzerland). The 
subcommittee (referred to below as the IRT) provided its report on 
February 4, 2004. The complete report, ``Report on Measures Relating to 
BSE in the United States,'' is available for viewing at http://www.aphis.usda.gov/lpa/issues/bse/BSE_tr_ban_ltr%20_enc_2.pdf.
    In summary, the IRT was complimentary of the scope, thoroughness, 
and appropriateness of the epidemiological investigation and concluded 
that the investigation conformed to international standards. The review 
team members concurred that the investigation should be terminated. In 
addition, the IRT made several policy recommendations designed to 
further reduce the risk of cattle being exposed to BSE. These 
recommendations included several changes that the Federal Government 
had already embarked upon related to SRMs, non-ambulatory (downer) 
cows, surveillance, laboratory diagnosis, feed restrictions, 
traceability (i.e., animal identification), education, control of 
implementation measures, and lessons learned. These Federal Government 
policies are discussed in the next section. A formal response to the 
IRT report, prepared collaboratively by USDA and FDA, may be viewed at 
http://www.aphis.usda.gov/lpa/issues/bse/bse_responsetorep.pdf.

C. Regulatory and Policy Actions

    APHIS, FSIS, and FDA have taken additional steps to specifically 
address the potential pathways or practices that the Harvard-Tuskegee 
Study said could contribute most either to the spread of BSE in cattle 
or to human exposure to the BSE agent should BSE be introduced into the 
United States.
Safeguards on Food and Feed Supplies
    FSIS, in a series of three interim final rules that were published 
and made effective on January 12, 2004, took additional measures to 
prevent the BSE agent from entering the human food supply. In its 
interim final rule titled,

[[Page 42292]]

``Prohibition on the Use of Specified Risk Materials for Human Food and 
Requirements for the Disposition of Non-Ambulatory Disabled Cattle'' 
(FSIS Docket No. 03-025IF; 69 FR 1861), and referred to below as the 
SRM rule, FSIS designated the brain, skull, eyes, trigeminal ganglia, 
spinal cord, vertebral column (excluding the vertebrae of the tail, the 
transverse process of the thoracic and lumbar vertebrae, and the wings 
of the sacrum), and dorsal root ganglia of cattle 30 months of age and 
older, and the tonsils and distal ileum of the small intestine of all 
cattle as SRM, and prohibited their use as human food. To ensure 
effective removal of the distal ileum, the SRM rule requires 
establishments to remove the entire small intestine and dispose of it 
as inedible.
    To facilitate the enforcement of the SRM rule, FSIS has developed 
procedures to verify the approximate age of cattle that are slaughtered 
in official establishments. Such procedures, based on records or 
examination of teeth, are intended to ensure that SRM from cattle 30 
months of age and older are effectively segregated from edible 
materials.\7\
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    \7\ See FSIS Notice 05-04, ``Interim Guidance for Non-Ambulatory 
Disabled Cattle and Age Determination,'' January 12, 2004, http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=/oppde/rdad/fsisnotices/5-04.pdf; and FSIS Notice 10-04, ``Questions and Answers 
Regarding the Age Determination of Cattle and Sanitation,'' January 
29, 2004, http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=/oppde/rdad/fsisnotices/10-04.pdf.
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    As provided by the SRM rule, materials designated as SRMs if they 
are from cattle 30 months of age and older will be deemed to be SRMs 
unless the establishment can demonstrate that they are from an animal 
that was younger than 30 months of age at the time of slaughter.
    Furthermore, FSIS has developed procedures to verify that cross 
contamination of edible tissue with SRMs is reduced to the maximum 
extent practical in facilities that slaughter cattle, or process 
carcasses or parts of carcasses of cattle, both younger than 30 months 
of age and 30 months of age and older.\8\ If an establishment uses 
dedicated equipment to cut through SRMs, or if it segregates cattle 30 
months of age and older from cattle younger than 30 months of age, then 
the establishment may use routine operational sanitation procedures 
(i.e., no special sanitation procedures are required). If the 
establishment doesn't segregate cattle 30 months of age and older from 
younger cattle, equipment used to cut through SRMs must be cleaned and 
sanitized before it is used on carcasses or parts from cattle less than 
30 months of age. FSIS believes that, due to the multiple risk 
mitigation measures implemented in the United States to prevent the 
spread of BSE, these procedures will reduce to the maximum extent 
possible cross contamination of carcasses with high-risk tissues. 
However, to assist in determining whether it should strengthen the 
measures required of establishments, FSIS issued a press release during 
the comment period for the SRM rule that specifically requested public 
comment on methods to prevent cross contamination of carcasses with 
SRMs.\9\
---------------------------------------------------------------------------

    \8\ See FSIS Notice 10-04.
    \9\ FSIS press release of March 31, 2004.
---------------------------------------------------------------------------

    The SRM rule also declared mechanically separated beef (MS(beef)) 
to be inedible and prohibited its use for human food. Additionally, the 
SRM rule prohibited all non-ambulatory disabled cattle for use as human 
food.
    The second interim final rule, titled, ``Meat Produced by Advanced 
Meat/Bone Separation Machinery and Meat Recovery (AMR) Systems' (FSIS 
Docket No. 03-038IF; 69 FR 1874-1885), prohibited products produced by 
advanced meat recovery (AMR) systems from being labeled as ``meat'' if, 
among other things, they contain CNS tissue. AMR is a technology that 
removes muscle tissue from the bone of beef carcasses under high 
pressure without incorporating significant amounts of bone and bone 
products into the final meat product. FSIS had previously established 
and enforced regulations that prohibited spinal cord from being 
included in products labeled ``meat.'' This interim final rule expanded 
that prohibition to include dorsal root ganglia (DRG), clusters of 
cells connected to the spinal cord along the vertebral column. In 
addition, because the vertebral column and skull of cattle 30 months of 
age and older have been designated as SRM, they cannot be used for AMR. 
Because they are not SRMs, the skull and vertebral column from cattle 
younger than 30 months of age may be used in AMR systems. However, 
establishments that use skulls and vertebral columns in the production 
of beef AMR product must be able to demonstrate that such materials are 
from cattle younger than 30 months of age.
    The third interim final rule, titled ``Prohibition on the Use of 
Certain Stunning Devices Used to Immobilize Cattle During Slaughter'' 
(FSIS Docket No. 01-0331IF; 69 FR 1885-1891), prohibited the use of 
penetrative captive bolt stunning devices that deliberately inject air 
into the cranial cavity of cattle because they may force large 
fragments of CNS tissue into the circulatory system of stunned cattle 
where they may become lodged in edible tissues.
    Also on January 12, 2004, FSIS published a notice announcing that 
it would no longer pass and apply the mark of inspection to carcasses 
and parts of cattle selected for BSE testing by APHIS until the sample 
is determined to be negative (FSIS Docket No. 03-048N; 69 FR 1892; 
``Bovine Spongiform Encephalopathy Surveillance Program'').
    FDA continues to conduct inspections to monitor compliance of feed 
mills, renderers, and protein blenders with the 1997 feed ban rule and 
is expanding the scope of its inspections to include other segments of 
animal feed production and use, such as transportation firms, farms 
that raise cattle, and animal feed salvage operations. Compliance by 
feed mills, renderers, and protein blenders with the feed ban is 
currently very high. Information on inspections and compliance is 
available at http://www.fda.gov/cvm/index/bse/RuminantFeedInspections.htm.
    FDA, like FSIS, has taken additional measures to prevent the BSE 
agent from entering the human food supply. In an interim final rule 
published in the Rules and Regulations section of today's Federal 
Register, FDA prohibits SRMs, the small intestine of all cattle, 
material from non-ambulatory disabled cattle, material from cattle not 
inspected and passed for human consumption, and MS (beef) from use in 
FDA-regulated human food, including dietary supplements, and cosmetics 
(FDA Docket No. 2004N-0081; ``Use of Materials Derived from Cattle in 
Human Food and Cosmetics'').
    This interim final rule on human food and cosmetics, as well as a 
second one related to animal feed, were announced by FDA on January 26, 
2004. The interim final rule on animal feed was to remove the current 
exemptions in 21 CFR 589.2000 for blood and blood products and plate 
waste, prohibit the use of poultry litter in ruminant feed, and require 
equipment, facilities, or production lines to be dedicated to 
nonruminant animal feed if firms use protein that is prohibited in 
ruminant feed.
    The IRT recommendations provide a different set of measures for 
reducing the risks associated with animal feed. The IRT approach is to 
prevent potentially infective tissues from ever entering animal feed 
channels. Although FDA believes the measures previously announced would 
serve to reduce the already small risk of BSE

[[Page 42293]]

spread through animal feed, the broader measures recommended by the 
IRT, if implemented, could make some of the previously announced 
measures unnecessary. Either approach would require a significant 
change in current feed manufacturing practices. Therefore, FDA believes 
that additional information is needed to determine the best course of 
action in light of the IRT recommendations and has decided not to issue 
an interim final rule with the changes to the feed ban described in the 
January 26 announcement. Instead, FDA is requesting additional 
information through this ANPRM on the recommendations of the IRT, as 
well as on other measures under consideration to protect the animal 
feed supply.
    The Federal Government has also taken additional significant 
nonregulatory actions in response to the detection of BSE in North 
America. These actions include enhancing surveillance for BSE; 
implementing a national animal identification system; enhancing 
laboratory diagnosis; and obtaining and providing guidance and 
strategies for the future.
Animal Surveillance
    On March 15, 2004, Secretary of Agriculture Ann Veneman announced a 
one-time enhanced BSE surveillance plan, targeting cattle from 
populations considered at highest risk for BSE, as well as a sampling 
of animals from the clinically normal, aged cattle population (over 30 
months as evidenced by the eruption of at least one of the second set 
of permanent incisors). The plan, implemented on June 1, 2004, 
incorporates recommendations from the IRT and the Harvard Center for 
Risk Analysis. Notably, the IRT has reviewed the surveillance plan and 
indicated that it is comprehensive and science-based, and that it 
addresses the important issues with regard to BSE surveillance in 
cattle.
    Over a period of 12-18 months, APHIS will test as many cattle as 
possible in the targeted high-risk population. Data obtained in this 
effort will help determine the probable prevalence of BSE in the United 
States and whether risk management policies need to be adjusted. If at 
least 268,500 targeted high-risk animals are sampled, we will be able 
to detect BSE even if as few as 5 animals in this targeted population 
are positive. The key to surveillance is to look at the population of 
animals where the disease is likely to occur. Thus, if BSE is present 
in the U.S. cattle population, there is a significantly better chance 
of finding the BSE within this targeted high-risk cattle population 
than within the general cattle population.
    In addition, FSIS public health veterinarians have begun assisting 
in APHIS' BSE animal surveillance efforts by collecting brain samples 
from all cattle condemned during ante-mortem inspection at federally 
inspected establishments. This allows APHIS to focus on sample 
collection at locations other than federally inspected establishments, 
such as rendering operations and farms.
    APHIS ensured access to slaughterhouses and rendering plants for 
sample collection via a final rule published March 4, 2004 (APHIS 
Docket No. 99-017-3, 69 FR 10137, ``Blood and Tissue Collection at 
Slaughtering and Rendering Establishments''). Samples may also be 
collected on the farm, at veterinary diagnostic laboratories, at public 
health laboratories, at veterinary clinics, sale barns, livestock 
auctions, etc.
    Strengthening of the passive surveillance system for BSE through 
outreach and education is an integral part of the USDA surveillance 
plan. In this regard, APHIS has developed plans to enhance existing 
educational materials and processes in conjunction with other Federal 
and State agencies. These outreach efforts will inform veterinarians, 
producers, and affiliated industries of the USDA surveillance goals and 
the sometimes subtle clinical signs of BSE, and will encourage 
reporting of suspect or targeted cattle on farm and elsewhere. One of 
the tools for reporting high-risk cattle, announced on June 8, 2004, is 
a toll-free number (1-866-536-7593).
    To help cover additional costs incurred by industries participating 
in the surveillance plan, and to help encourage reporting and 
collection of targeted samples, USDA may provide payments for certain 
transportation, disposal, cold storage, and other costs.
    For a complete discussion of the enhanced BSE surveillance plan 
that will be carried out over the next 12-18 months, refer to APHIS' 
Bovine Spongiform Encephalopathy (BSE) Surveillance Plan of March 15, 
2004 (available at http://www.aphis.usda.gov/lpa/issues/bse/BSE_Surveil_Plan03-15-04.pdf).
Laboratory Diagnosis
    Testing of BSE surveillance samples is conducted at APHIS' National 
Veterinary Services Laboratories (NVSL) and at a participating network 
of State and Federal veterinary diagnostic laboratories throughout the 
continental United States. USDA has approved 12 geographically 
dispersed laboratories to assist with BSE surveillance.
    USDA has also approved five rapid screening test kits and has 
provided funding for high-throughput laboratory equipment as necessary. 
The rapid screening test kits are commercially produced diagnostic test 
kits, intended for use in surveillance programs such as these. These 
kits are best used as screening tests--i.e., they are very sensitive 
and are intended to identify anything that might possibly be positive. 
Each of the laboratories will use one or more of the rapid screening 
tests with the goal of having initial results available within 24 to 72 
hours after the sample is collected.
    NVSL remains the national reference laboratory for BSE. If any 
sample reacts on the initial screening test, the tissues will be 
immediately forwarded to NVSL for confirmatory testing. Samples with 
this type of initial reaction will be reported as inconclusives. 
Samples will only be determined to be negative or positive by NVSL 
using immunohistochemistry and/or western blot confirmatory testing. 
NVSL will also conduct quality assurance check testing and test a 
certain number of routine samples to ensure proficiency in conducting 
all approved rapid screening tests.
    USDA will make public the number of tests conducted and the results 
on a periodic basis. Updates are available at http://www.aphis.usda.gov/lpa/issues/bse-enhan_surv/bse_test_results.html.
    The United States Government encourages and supports the 
development of new diagnostic tests for BSE and other TSEs. USDA 
researchers regularly discuss advancements in this area with their 
counterparts throughout the world and will evaluate all scientific data 
submitted as part of an application for USDA approval of a diagnostic 
test.
Animal Identification (Traceability)
    Animal disease outbreaks around the globe over the past decade and 
the detection of a BSE-positive cow in the United States in December 
2003 have intensified public interest in developing a national animal 
identification program for the purpose of protecting animal health.
    Having a system that can identify individual animals or groups, the 
premises where they are located, and the date of entry to each premises 
is fundamental to controlling any disease threat, foreign or domestic, 
to U.S. animal resources. Further, we must be able to retrieve this 
information in a timely manner after confirmation of disease outbreak 
in order to implement successful intervention strategies.

[[Page 42294]]

    While there is currently no nationwide animal identification system 
in the United States for all animals of a given species, some segments 
of certain species are required to be identified as part of current 
APHIS disease eradication activities. In addition, some significant 
regional voluntary identification programs are in place, and others are 
currently being developed and tested.
    USDA has defined several key objectives for a national system. 
These include: (1) Allowing producers, to the extent possible, the 
flexibility to use current systems or adopt new ones; (2) having a 
system that is technology neutral, so that all existing effective 
technologies and new technologies that may be developed in the future 
may be utilized; (3) having a system that builds upon national data 
standards to ensure that a uniform and compatible system evolves; (4) 
having a system that does not preclude producers from being able to use 
it with production management systems that respond to market 
incentives; and (5) designing the architecture so that the system does 
not unduly increase the role and size of the Government.
    Design and implementation of such a national animal identification 
system are well under way (see http://www.aphis.usda.gov/lpa/issues/nais/nais.html). USDA is moving forward first on a voluntary basis, to 
integrate the various types of animal identification programs that 
currently exist in the United States, and then will scale up to the 
national level, to include those producers and animals that are not 
currently in an animal identification program. The goal is to create an 
effective, uniform, consistent, and efficient national system.
    APHIS will initially fund cooperative agreements to help State and 
Tribal governments establish premises identification systems and to 
evaluate additional identification pilot projects that could also 
become a part of the overall animal identification system. Associations 
and other segments of the livestock industry may participate in State 
and Tribal projects. APHIS posted a request for proposals for these 
cooperative agreements in June and will accept applications until July 
15, 2004. APHIS anticipates initiating projects funded through these 
cooperative agreements in August. USDA is currently conducting a series 
of listening sessions (June-August 2004) across the country, inviting 
public discussion on the national animal identification program.
Guidance and Strategy
    The Federal Government has several existing mechanisms to ensure 
appropriate guidance and involvement from outside experts and 
interested stakeholders. The Secretary of Agriculture's Advisory 
Committee on Foreign Animal and Poultry Diseases (SACFAPD), which has 
17 members from industry, States, and academia, advises the Secretary 
on program operations, measures to prevent the introduction of foreign 
animal diseases into the United States, and contingency measures should 
such a disease be introduced into the United States. This group meets 
regularly and can also solicit public and expert advice. In fact, the 
IRT was convened as a subcommittee of the SACFAPD. Similarly, FDA 
obtains guidance from outside experts through its Transmissible 
Spongiform Encephalopathy Advisory Committee (TSEAC). In addition, 
FDA's TSEAC includes a representative from APHIS.
    The Federal Government also obtains guidance and advice from 
experts within the Government. USDA has an internal Transmissible 
Spongiform Encephalopathy (TSE) Working Group that provides scientific 
recommendations related to TSEs, including BSE. This technical group 
meets regularly and includes representatives from FSIS and USDA's 
Agricultural Research Service, as well as from HHS' Centers for Disease 
Control and Prevention, the National Institutes of Health, and FDA, and 
the Department of Defense, as needed. There is also a policy level 
Interagency TSE Working Group that provides support and advice.
    Furthermore, USDA and HHS participate on international working 
groups set up to prevent the spread of BSE to new areas of the world 
and to standardize approaches for addressing BSE surveillance and 
response. USDA and HHS participate in OIE meetings as members and 
consultants, and U.S. representatives offer technical advice on BSE-
related issues and uphold U.S. interests in the World Health 
Organization and the Pan American Health Organization as well. Since 
1986, the United States has exchanged scientists with several European 
countries, and U.S. officials have historically and routinely met with 
their counterparts in many countries on animal health risk mitigation 
measures. A standing North American Animal Health Committee that 
includes chief veterinary officers from Canada, Mexico, and the United 
States has developed and is working to implement a North American BSE 
strategy. After the finding of the BSE-positive cow in Canada in May 
2003, U.S., Canadian, and Mexican officials sent a letter to the OIE 
regarding a scientific approach to BSE and trade issues. The United 
States has also taken a leadership role by proposing a new ``minimal 
risk'' BSE classification and criteria for trade in low-risk products 
for countries with established mitigation measures and a low incidence 
of BSE (APHIS Docket No. 03-080-1; 68 FR 62386-62405; November 4, 2003: 
``Bovine Spongiform Encephalopathy; Minimal Risk Regions and 
Importation of Commodities'').

IV. OIE Standards

    As recognized in the Agreement on the Application of Sanitary and 
Phytosanitary Measures (``SPS Agreement'') under the auspices of the 
World Trade Organization (``WTO''), the OIE is the relevant 
international organization responsible for development and periodic 
review of standards, guidelines, and recommendations with respect to 
animal health and zoonoses (diseases that are transmissible from 
animals to humans). The OIE criteria for terrestrial animals (mammals, 
birds, and bees) are detailed in the Terrestrial Animal Health Code 
(available on the OIE Web site at http://www.oie.int).
    Chapter 2.3.13 of the Terrestrial Animal Health Code describes the 
OIE standards with regard to BSE and is supplemented by Appendix 3.8.4 
on surveillance and monitoring systems for BSE. The OIE standards for 
diagnostic tests with regard to BSE are described in Chapter 2.3.13 of 
the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals. 
However, the OIE standards are constantly evolving and are subject to 
change in response to new scientific findings and perspectives.
    The current OIE standards contain criteria for establishing the BSE 
risk status of a country or zone. Under the current standards, the BSE-
risk status of a country or zone is determined on the basis of a risk 
assessment identifying all potential factors for BSE occurrence and 
their historic perspective; an assessment of the likelihood that a TSE 
agent has been introduced via the importation of potentially 
contaminated animals or commodities (i.e., meat-and-bone meal or 
greaves (the protein-containing residue obtained after the partial 
separation of fat and waste during the process of rendering), live 
animals, animal feed and feed ingredients, and products of animal 
origin for human consumption); and an assessment of the likelihood of 
exposure of the BSE agent to cattle, based on a consideration of a 
number of criteria, including the

[[Page 42295]]

existence and duration of a feed ban and BSE surveillance and 
monitoring programs. In addition, risk status levels are based on the 
length of time for demonstrated compliance with these criteria and on 
the reporting of BSE cases or BSE incidence rate.
    To increase the likelihood of detecting BSE, the OIE recommends 
surveillance targeting cattle displaying clinical signs compatible with 
BSE and cattle that have died or been killed for reasons other than 
routine slaughter. In countries or zones not free of BSE, the OIE 
recommends routine sampling at slaughter. Surveillance should focus 
primarily on cattle over 30 months of age. The OIE also recommends a 
minimum number of samples to be taken from the targeted population for 
effective surveillance, based on the total cattle population over 30 
months of age.
    The OIE currently specifies five BSE status levels for countries or 
zones: Free, provisionally free, minimal risk, moderate risk, and high 
risk. The purpose of the categorization system is to enable and 
encourage appropriate risk mitigation measures to be applied to 
commodities for trade.
    The OIE also sets international standards for trade in live cattle, 
fresh meat and meat products, gelatin and collagen prepared from bones, 
tallow and tallow derivatives, and dicalcium phosphate, according to 
the BSE risk status of a country or zone. In order to protect public 
and animal health, the OIE currently recommends different risk 
mitigating measures, with increased requirements as the status of a 
country or zone moves from lower to higher levels of BSE risk. The 
present OIE Code does not suggest a total embargo of animals and animal 
products coming from BSE affected countries, not even from countries 
considered as having high BSE risk, as long as the proper risk 
mitigation measures are applied.
    The OIE also identifies certain commodities that should not require 
any BSE-related restrictions, regardless of the BSE status of the 
exporting country or zone. For example, the Terrestrial Animal Health 
Code does not recommend any restrictions, regardless of the BSE status 
of the country, in trade of semen, embryos, milk, milk products, and 
gelatin and collagen coming from hides and skins because these products 
or tissues have not demonstrated BSE infectivity in cattle.
    The actions taken by the U.S. Government to prevent the 
introduction and spread of BSE in the United States are generally 
consistent with international standards for BSE, although not in all 
cases exactly the same. For example, U.S. surveillance for BSE in 
cattle has exceeded the OIE standards since 1993. Based on an adult 
cattle population of approximately 40 million, the OIE standard 
(Terrestrial Animal Health Code Appendix 3.8.4) calls for a minimum of 
433 samples. By comparison, the United States has increased the number 
of samples from approximately 700 in fiscal year 1993 to approximately 
20,000 in fiscal year 2002.
    USDA appreciates the significant contributions of the OIE to 
science-based understanding of the true BSE-related risks in 
international trade and will continue to work with the OIE and other 
relevant international organizations. The United States is also taking 
a leadership role by proposing criteria for low-risk product trade with 
countries that have a low incidence of BSE and historically strong risk 
mitigation measures, mentioned previously in this document in section 
III, The Case in Washington State and U.S. Actions in Response, under 
Guidance and Strategy.

V. Recommendations of the IRT and Additional Measures for Consideration

A. Response Actions

    In its general remarks about actions taken by the United States in 
response to the case of BSE in Washington State, the IRT, under 
``Response actions,'' recommended that policy actions under 
consideration by the United States achieve the following objectives:

     Reduce public health risk for consumer protection.
     Limit recycling and amplification of the agent.
     Establish the level of effectiveness of measures through 
surveillance.
     Prevent any inadvertent introduction of BSE from abroad in 
the future.
     Contribute to the prevention of the spread of the epidemic 
worldwide [p. 3].
    The IRT report further stated:

    To achieve the above objectives, a system of complementary 
barriers, and implementation and enforcement of all measures on the 
national level, is necessary.
    The objectives cannot be successfully achieved by government 
alone; effective implementation of measures requires a shared 
commitment and action on the part of national and state governments, 
producers, consumers, private industry, and veterinary 
professionals. Extensive national coordination and cooperation is 
imperative, and should be extended to include the continent of North 
America. We suggest that a BSE task force, which includes 
governmental and non governmental stakeholders, is established under 
the leadership of the USDA in order to assure that policies are 
developed and implemented in a consistent, scientifically valid 
manner. [p. 3]

    As noted earlier in section III, The Case in Washington State and 
U.S. Actions in Response, under Guidance and Strategy, both the 
Secretary of Agriculture and the Commissioner of FDA have advisory 
committees, which include both governmental and nongovernmental 
stakeholders, to provide guidance on issues concerning BSE and other 
TSEs. There are also technical and policy level interagency working 
groups on TSEs.
    USDA welcomes comment on the following question:
    1. Would there be value in establishing a specialized advisory 
committee or standing subcommittee on BSE?
    The IRT also evaluated actions taken by the U.S. Government in 
response to the confirmation of the case of BSE in the United States 
and made recommendations regarding further actions that could provide 
additional public or animal health benefits. We are requesting public 
comment below on additional measures we are considering based on the 
IRT's recommendations. Because we believe that prior actions taken by 
the Federal Government already address IRT recommendations related to 
surveillance, laboratory diagnosis, non-ambulatory (downer) cattle, and 
certain other recommendations (e.g., concerning the mechanical removal 
of bone from beef) (see the discussions in section III, The Case in 
Washington State and U.S. Actions in Response), we are not specifically 
requesting comment on those recommendations.

B. The Human Food Supply

    In the section of the IRT report headed, ``Specified Risk Materials 
(SRM),'' the IRT stated:

    Unless aggressive surveillance proves the BSE risk in the USA to 
be minimal according to OIE standards, the [IRT] recommends that the 
SRM identified below be excluded from both the human and animal food 
chains.

     Brain and spinal cord of all cattle over 12 months of 
age.
     Skull and vertebral column of cattle over 12 months of 
age--these are not inherently infected, but cannot be separated from 
dorsal root/trigeminal ganglia or from residual contamination with 
CNS tissue.
     Intestine--from pylorus to anus--from all cattle.
    In the mean time, until the level of BSE risk has been 
established, the [IRT] concedes that exclusion of CNS, skull, and 
vertebral column from cattle over 30 months, and intestines from 
cattle of all ages, for use in human food is a reasonable temporary 
compromise. [pp. 3-4]


[[Page 42296]]


    USDA has initiated an aggressive and comprehensive surveillance 
program that will assist in estimating the prevalence of BSE in the 
United States and provide a basis for further assessments of whether 
and how U.S. actions related to BSE should be adjusted. Also, FSIS and 
FDA require the exclusion of CNS tissue, skull, and vertebral column 
from cattle 30 months of age and older, and the small intestine and 
tonsils from cattle of all ages, from human food, including dietary 
supplements, and cosmetics.
    With regard to the age of cattle from which SRMs should be removed, 
FSIS and FDA have specified that CNS tissue, skull and vertebral column 
should be removed from cattle 30 months of age and older. Research to 
date indicates that 30 months is the appropriate threshold for removal 
of these materials unless surveillance indicates that there is a high 
prevalence of BSE in the U.S. cattle population, which the agencies 
believe is unlikely because of the feed and import restrictions that 
the Federal Government has imposed. The reason that age matters at all 
is that levels of infectious agent in certain tissues vary with the age 
of animal. Pathogenesis studies, where tissues obtained from orally 
infected calves were assayed for infectivity, have shown that 
infectivity was not detected in most tissues until at least 32 months 
post-exposure.\10\ The exception to this is the distal ileum, the 
distal portion of the small intestine, where infectivity was confirmed 
from experimentally infected animals as early as 6 months post-exposure 
and tonsils, where infectivity was confirmed at 10 months post-
exposure.
---------------------------------------------------------------------------

    \10\ Wells, G.A.H., et al. 1994. Infectivity in the ileum of 
cattle challenged orally with bovine spongiform encephalopathy. 
Veterinary Record. 135 (2): 40-41.
    Wells, G.A.H., et al. 1998. Preliminary observations on the 
pathogenesis of experimental bovine spongiform encephalopathy (BSE): 
An update. Veterinary Record. 142: 103-106.
    European Union Scientific Steering Committee (EU SSC), 2002. 
Update of the opinion on TSE infectivity distribution in ruminant 
tissues (initially adopted by the Scientific Steering Committee at 
its meeting of 10-11 January 2002 and amended at its meeting of 7-8 
November 2002) following the submission of (1) a risk assessment by 
the German Federal Ministry of Consumer Protection, Food, and 
Agriculture and (2) new scientific evidence regarding BSE 
infectivity distribution in tonsils; European Commission, Scientific 
Steering Committee, Health and Consumer Protection Directorate 
General; http://www.europa.eu.int/comm./food/fs/sc/ssc/outcome_en.pdf.
---------------------------------------------------------------------------

    Although a few cases of BSE have been found in cattle under 30 
months of age, research demonstrates that the shorter incubation period 
(i.e., infection developing in less than 30 months) is apparently 
linked to younger animals receiving a relatively large infectious 
dose.\11\ The younger cases have occurred primarily in countries with 
significant levels of circulating infectivity. Specifically, BSE has 
been found in animals less than 30 months of age in the United Kingdom 
in the late 1980s to early 1990s, when the incidence of BSE was 
extremely high. This research also suggests that a calf must receive an 
oral dose of 100 grams of infected brain material containing high 
levels of the infectious agent to produce disease within a minimum of 
approximately 30 months.\12\
---------------------------------------------------------------------------

    \11\ EU SSC 2002 (see footnote 9).
    \12\ EU SSC 2002 (see footnote 9).
    Department for Environment, Food and Rural Affairs (DEFRA), 
U.K., 2003; DEFRA BSE information, http://www.defra.gov.uk/animalh/bse/index.htm.
---------------------------------------------------------------------------

    BSE testing in the European Union (EU) was conducted throughout the 
year 2001. This testing revealed only two positive animals that were 
younger than 30 months of age in a total of 2,147 positive cases. Of 
note is that these animals were 28 and 29 months of age. For reference, 
in 2001, a total of 8,516,227 tests were conducted within the EU, and, 
of those, 1,366,243 tests were conducted on animals less than 30 months 
of age. In 2002, there were no animals less than 30 months of age that 
were positive in the EU testing scheme. Approximately 10.2 million 
tests were conducted in EU Member States in 2002, and, of these, 1.6 
million were conducted on animals less than 30 months of age. The 
average mean age of positive animals in the EU in 2002 was 96.9 months, 
an increase from 85.9 months in 2001.\13\
---------------------------------------------------------------------------

    \13\ European Commission (EC), 2002; Report on the monitoring 
and testing of ruminants for the presence of transmissible 
spongiform encephalopathy (TSE) in 2001, European Commission Health 
and Consumer Protection Directorate-General; http://europa.eu.int/comm/food/fs/bse/bse45_en.pdf.
    European Commission (EC), 2003; Report on the monitoring and 
testing of ruminants for the presence of transmissible spongiform 
encephalopathy (TSE) in 2002, European Commission Health and 
Consumer Protection Directorate-General; http://europa.eu.int/comm/food/fs/bse/testing/annual_%20report_2002_en.pdf.
---------------------------------------------------------------------------

    This suggests an effective and prudent dividing line for purposes 
of mitigating risk. Infected cattle over 30 months of age may have 
levels of the abnormal prion in affected tissues that are sufficient to 
infect other animals fed protein derived from these tissues. Infected 
cattle younger than 30 months of age are unlikely to have infectious 
levels of the prion protein.\14\ The 30-month age limit is accepted 
internationally in BSE standards set by various countries and is 
consistent with OIE recommendations.
---------------------------------------------------------------------------

    \14\ Wells, et al.. 1994; Wells, et al.. 1998; EU SSC 2002 (see 
footnote 9).
---------------------------------------------------------------------------

    With respect to the IRT recommendation that the entire intestine 
from cattle of all ages should be excluded from the human and animal 
food chains, FSIS noted in its SRM rule that BSE infectivity has only 
been confirmed in the distal ileum of the small intestine. FSIS 
requires the entire small intestine to be removed and disposed of as 
inedible to ensure effective removal of the distal ileum. Consistent 
with USDA's restrictions, FDA prohibits the use of the small intestine 
in FDA-regulated human food and cosmetics.

    Note: The aspect of this recommendation pertaining to removal of 
SRMs from animal feed is addressed below under ``Animal Feed 
Restrictions.'')

    FSIS and FDA request comment, especially scientific information, on 
the following question:
    2. What data or scientific information is available to evaluate the 
IRT recommendation described above, including that aspect of the 
recommendation concerning what portion of the intestine should be 
removed to prevent potentially infective material from entering the 
human food and animal feed chains?

C. Animal Feed Restrictions

Specified Risk Materials (SRMs)
    In the ``Feed Restrictions'' section of the report, the IRT 
recommended: ``All SRM should be excluded from all animal feed, 
including pet food.'' [p. 5] FDA has prohibited the use of most 
mammalian proteins in ruminant feed since 1997. The IRT report stated 
that, ``Considering the BSE situation in North America, the [IRT] 
believes the partial (ruminant to ruminant) feed ban that is currently 
in place is insufficient to prevent exposure of cattle to the BSE 
agent.'' [p. 5] The IRT further stated that, ``While science would 
support the feed bans limited to the prohibition of ruminant derived 
[meat and bone meal] MBM in ruminant feed, practical difficulties of 
enforcement demand more pragmatic and effective solutions.'' [p. 6] 
Specifically, the IRT cited epidemiological evidence in the United 
Kingdom that highlight the dangers of cattle infection through the 
consumption of feed that had been contaminated accidentally when 
manufactured in premises that legitimately used mammalian meat and bone 
meal in feed for pigs and poultry. [p. 5] In addition, the IRT report 
cited an ongoing attack rate study at the Veterinary Laboratories 
Agency in the United Kingdom that demonstrates

[[Page 42297]]

transmission of BSE with 10 mg of infectious brain tissue. [p. 5] 
Although not yet published, more recent results from this study have 
demonstrated transmission with a lower dose of infectious brain tissue. 
These levels are significantly lower than the 1 gram infectious dose 
that had been demonstrated in the same study at the time the 1997 BSE 
feed rule was issued. Further, the Harvard-Tuskegee Study showed that 
removing SRMs from all animal feed reduces by 88 percent the potential 
exposure of cattle to the BSE agent when 10 BSE infected cattle are 
introduced into the United States. Accordingly, FDA has tentatively 
concluded that it should propose removing SRMs from all animal feed to 
adequately control the risks associated with cross contamination 
throughout feed manufacture and distribution and with intentional or 
unintentional misfeeding on the farm. FDA is currently working on a 
proposal to accomplish this goal.
    To assist FDA in completing that proposal, FDA seeks comment on the 
following questions:
    3. What information, especially scientific data, is available to 
support or refute the assertion that removing SRMs from all animal feed 
is necessary to effectively reduce the risks of cross-contamination of 
ruminant feed or of feeding errors on the farm? What information is 
available on the occurrence of on-farm feeding errors or cross-
contamination of ruminant feed with prohibited material?
    4. If SRMs are prohibited from animal feed, should the list of SRMs 
be the same list as for human food? What information is available to 
support having two different lists?
    5. What methods are available for verifying that a feed or feed 
ingredient does not contain SRMs?
    6. If SRMs are prohibited from animal feed, what requirements 
(labeling, marking, denaturing) should be implemented to prevent cross-
contamination between SRM-free rendered material and material rendered 
from SRMs?
    7. What would be the economic and environmental impacts of 
prohibiting SRMs from use in all animal feed?
    8. What data are available on the extent of direct human exposure 
(contact, ingestion) to animal feed, including pet food? To the degree 
such exposure may occur, is it a relevant concern for supporting SRM 
removal from all animal feed?
Cross Contamination
    The ``Feed restrictions'' section of the IRT report also stated:

    Cross contamination must be prevented throughout the feed chain, 
from reception and transportation of feed ingredients, during the 
manufacturing process, through transportation and storage of 
finished feed, and on farm where mixing, blending, and feeding will 
occur. [p. 6]

    The 1997 feed rule required manufacturers and distributors that 
handle both prohibited and nonprohibited material to control cross 
contamination by either: (1) Maintaining separate equipment or 
facilities; or (2) using clean-out procedures or other means adequate 
to prevent carry-over of prohibited material into feed for ruminant 
animals. In response to the finding of a BSE-positive cow in Washington 
State, FDA announced its intention to strengthen measures to prevent 
cross contamination by requiring dedicated equipment or facilities. 
However, in light of the IRT's recommendations, if SRMs are prohibited 
in all animal feed, dedicated facilities may no longer be necessary to 
reduce the risk associated with cross contamination. Therefore, FDA is 
reevaluating the need for requiring dedicated facilities.
    FDA seeks comment on the following questions:
    9. What information, especially scientific data, is available to 
show that dedicated facilities, equipment, storage, and transportation 
are necessary to ensure that cross contamination is prevented? If FDA 
were to prohibit SRMs from being used in animal feed, would there be a 
need to require dedicated facilities, equipment, storage, and 
transportation? If so, what would be the scientific basis for such a 
prohibition?
    10. What would be the economic and environmental impacts of 
requiring dedicated facilities, equipment, storage, and transportation?
    11. What information, especially scientific data, is available to 
demonstrate that clean-out would provide adequate protection against 
cross contamination if SRMs are excluded from all animal feed?
All Mammalian and Avian Protein
    As reported in the ``Feed restrictions'' section of the IRT report:

    The [IRT] recommends that the current feed ban be extended to 
exclude all mammalian and poultry protein from all ruminant feeds, 
and that this ban as well as measures to prevent cross contamination 
be strongly enforced. This recommendation must be enforced through 
an inspection program including sampling and testing of feed. [p. 6]

    As noted previously, although the IRT agreed that ``science would 
support the feed bans limited to the prohibition of ruminant derived 
MBM in ruminant feed,'' the IRT stated that ``practical difficulties of 
enforcement demand more pragmatic and effective solutions.'' [p. 6] In 
particular, the IRT said:

    The prohibition of the use of all MBM (including avian) in 
ruminant feed is justified partly due to the issues of cross 
contamination as well as the current problems in differentiating 
mammalian and avian MBM. It also prevents the inclusion of ruminant 
derived protein contained within the lumen of porcine or avian 
intestines at slaughter in animal feed that may be used for 
ruminants. [p. 6]

    Although the IRT discussed the problems with rendered MBM, the IRT 
report did not specifically address the potential risks from other 
mammalian and avian protein, such as milk, blood, gelatin, and tallow 
(rendered fat) that may contain small amounts of protein. The 1997 
final rule, which banned the use of most mammalian protein in ruminant 
feed, did not include these materials in the definition of animal 
proteins prohibited in ruminant feed because they were not considered 
to pose a risk of BSE transmission. Prior to release of the IRT 
recommendations, FDA had announced its intentions to eliminate 
exemptions in the current ruminant feed rule for blood and blood 
products and plate waste, and to prohibit the practice of incorporating 
poultry litter into ruminant feed. FDA is now evaluating whether the 
announced measures need to be modified in light of the IRT 
recommendations. With respect to tallow, the OIE categorizes tallow 
with a maximum level of insoluble impurities of 0.15 percent as 
protein-free tallow and recommends that tallow that meets this standard 
be freely traded regardless of the BSE status of the country of origin.
    FDA seeks comment on the following questions:
    12. What information, especially scientific data, supports banning 
all mammalian and avian MBM in ruminant feed?
    13. If SRMs are required to be removed from all animal feed, what 
information, especially scientific data, is available to support the 
necessity to also prohibit all mammalian and avian MBM from ruminant 
feed, or to otherwise amend the existing ruminant feed rule?
    14. What would be the economic and environmental impacts of 
prohibiting all mammalian and avian MBM from ruminant feed?
    15. Is there scientific evidence to show that the use of bovine 
blood or blood products in feed poses a risk of BSE transmission in 
cattle and other ruminants?

[[Page 42298]]

    16. What information is available to show that plate waste poses a 
risk of BSE transmission in cattle and other ruminants?
    17. If FDA were to prohibit SRMs from being used in animal feed, 
would there be a need to prohibit the use of poultry litter in ruminant 
feed? If so, what would be the scientific basis for such a prohibition?
    18. What would be the economic and environmental impacts of 
prohibiting bovine blood or blood products, plate waste, or poultry 
litter from ruminant feed?
    19. Is there any information, especially scientific data, showing 
that tallow derived from the rendering of SRMs, dead stock, and non-
ambulatory disabled cattle poses a significant risk of BSE transmission 
if the insoluble impurities level in the tallow is less than 0.15 
percent?
Non-Ambulatory (Downer) Cattle
    In the ``Non-ambulatory (downer) cows'' section of the report, the 
IRT noted the need to prevent potentially infective tissues from 
entering the feed chain. [p. 4] In addition to downer cattle, FDA is 
concerned about cattle that die on the farm or are killed for humane 
reasons (i.e., dead stock) because they are also among the highest risk 
cattle population. Furthermore, little, if any, infrastructure is in 
place for removal of SRMs from cattle that are not slaughtered as part 
of the routine process that occurs at government inspected slaughter 
establishments. As previously discussed, the Harvard-Tuskegee Study 
showed that prohibiting rendering of animals that die on the farm would 
reduce the potential cases of BSE following hypothetical exposure by a 
further 82 percent from the base case scenario. Thus, FDA is evaluating 
the need to prohibit materials from non-ambulatory disabled cattle and 
dead stock from use in all animal feed.
    FDA seeks comment on the following questions:
    20. Can SRMs be effectively removed from dead stock and non-
ambulatory disabled cattle so that the remaining materials can be used 
in animal feed, or is it necessary to prohibit the entire carcass from 
dead stock and non-ambulatory disabled cattle from use in all animal 
feed?
    21. What methods are available for verifying that a feed or feed 
ingredient does not contain materials from dead stock and non-
ambulatory disabled cattle?
    22. What would be the economic and environmental impacts of 
prohibiting materials from dead stock and non-ambulatory disabled 
cattle from use in all animal feed?
Disposal of SRMs and Non-Ambulatory Disabled Cattle
    Additionally, in the ``Feed restrictions'' section of the report, 
the IRT stated:

    Recognising the absence of an established infrastructure for the 
separation and disposal of SRM or MBM the subcommittee accepted that 
a staged approach may be necessary for implementation. Exclusion and 
destruction of such a high volume of raw material is a massive 
burden on all countries currently affected by BSE. Given the 
susceptibility of cattle to low dose exposure, and the fact that no 
processing system exists at present to guarantee destruction of 
infectivity in commercial processes, it is probable that restoration 
of traditional uses in feed may be impossible. More radical and 
innovative solutions are required to enable the safe use of such 
materials in future. This should include adding value through their 
use for purposes other than the manufacture of feed and fertilisers 
(e.g. as a fuel source.) [p. 6]

    USDA's Rural Business-Cooperative Service announced on May 18, 
2004, a pilot project to provide guaranteed loans to rural small 
businesses for developing renewable energy systems primarily through 
use of specified risk materials, non-ambulatory cattle, or other cattle 
deemed to be at risk of carrying BSE (69 FR 28111-29119). Applications 
must be received by August 16, 2004.
    APHIS welcomes comment on the following question:
    23. What other innovative solutions could be explored?

D. Animal Identification (Traceability)

    In the section of the IRT report headed, ``Traceability,'' the IRT 
acknowledged that the U.S. Government has ``recognized the importance 
of effective identification and traceability systems, that have value 
not only for the cost-effective and rapid tracing of animals for 
culling, but also for containment of contagious diseases.'' [p. 6] The 
IRT ``encourages the implementation of a national identification system 
that is appropriate to North American farming.'' [p. 6]
    As discussed in section III, The Case in Washington State and U.S. 
Actions in Response, under Animal Identification (Traceability), APHIS 
is implementing a national animal identification system.
    The national animal identification system will allow the Federal 
Government to trace back and trace forward animals potentially exposed 
to a disease of concern. Traceback refers to the ability to track an 
animal's location over its lifespan and the ability to determine which 
animals may have been in contact with the diseased animal or shared a 
contaminated feed supply. Trace forward data provides locations of 
animals moved out of the premises of concern that may have been exposed 
to the disease. When fully implemented, the national animal 
identification system calls for a trace to be completed within 48 hours 
of detecting a disease, thereby helping to contain an outbreak. The 
ability to achieve the 48-hour goal is directly related to the 
completeness of animal movement data that is reported to the national 
system. Developing and establishing all components of this national 
system present significant challenges.
    APHIS recognizes the need to be able to ensure that data provided 
by producers is protected, and that all components of the system are in 
place and have been tested, before making the system mandatory. APHIS 
also recognizes that market forces will affect producer involvement 
(e.g., some establishments may begin to accept only animals that are 
identified under the national system).
    APHIS invites comment on the following questions:
    24. When and under what circumstances should the program transition 
from voluntary to mandatory?
    25. What species should be covered, both initially and in the 
longer term? Specifically, should the initial emphasis be on cattle, or 
also cover other species? If so which? Which species should be covered 
by the program when it is fully implemented? What priority should be 
given to including different species?

E. Education

    In the section of the IRT report headed, ``Education,'' the IRT 
stated:

    BSE educational programs must be designed to meet the needs of 
multiple audiences with variable levels of scientific training. 
Countries around the world have routinely underestimated the need 
for a wide variety of educational materials and training techniques 
to meet both technical and non-technical audiences. The [IRT] 
recommends that extensive education and training materials be 
developed in collaboration with academic, professional, trade and 
consumer organizations so that scientifically sound and accurate 
information about the nature of BSE and the importance of aggressive 
prevention and control strategies can be disseminated widely and 
incorporated into the curricula of schools, college, universities 
and professional continuing education programs. As traceability, 
transparency and access to current information increases, so does 
consumer confidence and effectiveness of the control and prevention 
measures. [pp. 6-7]

    FDA, FSIS, and APHIS continue to develop educational and training 
materials. BSE became a reportable

[[Page 42299]]

disease in the United States in 1986. In May 1990, USDA began 
educational outreach to veterinarians, cattle producers, and laboratory 
diagnosticians regarding the clinical signs and diagnosis of BSE. These 
activities have been broadened both in terms or scope and targeted 
audiences in recent years, to include awareness programs for personnel 
involved in the transportation, marketing, and slaughter of cattle, as 
well as the general public, through various means, including frequent 
briefings and press conferences, fact sheets, videotapes, and 
information on its web site. FDA has conducted training for Federal and 
State investigators conducting inspections of feed mills, rendering 
establishments, and other regulated facilities, developed educational 
materials, including a CD, for investigators and the industry on the 
inspection process, developed guidance documents for each of the 
industry segments affected by the regulations, available on the 
Internet and in Spanish; and collaborated with industry organizations 
to develop educational materials for specific audiences.
    All three agencies welcome comment on the following questions:
    26. How can training and educational materials be designed or 
improved to meet the needs of multiple audiences with variable levels 
of scientific training?
    27. How can the Federal Government increase access to these 
materials?

VI. Other Considerations

A. Animal Feed Measures

    FDA believes it is necessary to consider the current state of 
technology when developing new requirements for animal feeds. The IRT 
report cites the limitations of sampling techniques and test 
sensitivity as the rationale, in part, for why further restrictions are 
needed to prevent cross contamination. The IRT noted:

    If at some point it becomes possible through other means (e.g., 
inspection, testing, and enforcement) to achieve the equivalent 
result of assuring that no ruminant proteins are ingested by 
ruminants, then exclusion of all mammalian protein from feed for 
ruminants may not be required.

    FDA is interested in the impact of technology development on all 
possible new requirements and seeks comment on the following questions:
    28. Should FDA include exemptions to any new requirements to take 
into account the future development of new technologies or test methods 
that would establish that feed does not present a risk of BSE to 
ruminants?
    29. If so, what process should FDA use to determine that the 
technologies or test methods are practical for use by the feed industry 
and ruminant feeders and provide scientifically valid and reliable 
results?

B. FDA Authority

    FDA requests comments on the following questions:
    30. Do FDA's existing authorities under the Federal Food, Drug, and 
Cosmetic Act (that address food adulteration and misbranding) and under 
the Public Health Service Act (that address the prevention and spread 
of communicable diseases) provide a legal basis to ban the use of SRMs 
and other cattle material in nonruminant animal feed (e.g., feed for 
horses, pigs, poultry, etc.) notwithstanding that such materials have 
not been shown to pose a direct risk to nonruminant animals? More 
specifically, under FDA's existing legal authorities, would the 
potential occurrence of on-farm feeding errors, of cross contamination 
of ruminant feed with SRMs and other cattle material, or of human 
exposure to nonruminant feed (including pet food) provide a basis to 
ban SRMs and other cattle material from all animal feed?
    31. Are there other, related legal issues on which FDA should 
focus?

C. Sanitation and Cross Contamination

    As discussed in section III, The Case in Washington State and U.S. 
Actions in Response, under Safeguards on Food and Feed Supplies, to 
ensure that that establishments that slaughter or process cattle that 
are 30 months of age or older, as well as cattle that are younger than 
30 months of age, are taking appropriate actions to prevent 
contamination of edible carcasses and parts with SRMs, FSIS has 
developed procedures for its inspection program personnel to verify 
that the equipment (e.g., saws and knives) is properly cleaned and 
sanitized between carcasses or parts. FSIS also issued a press release 
during the comment period for its SRM rule to specifically solicit 
public comment on methods used to prevent cross contamination of 
carcasses with SRMs. One comment has suggested that FSIS require 
dedicated equipment for the removal and severing of SRMs, noting that 
the Canadian Food Inspection Agency requires that Canadian 
establishments use dedicated knives to sever the spinal cord of cattle 
30 months of age and older. Also, because cattle infected with BSE are 
more likely to contain infectious levels of the BSE agent if they are 
30 months of age and older, equipment that comes in contact with SRMs 
exclusively from cattle 30 months of age and older could potentially 
become contaminated with high levels of the BSE agent and come in 
contact with edible tissue. Therefore, FSIS is evaluating the need for 
additional sanitation requirements to prevent cross contamination of 
edible portions of carcasses with SRMs in establishments that 
predominantly slaughter cattle 30 months of age and older.
    FSIS welcomes comment, especially scientific information, on the 
following questions:
    32. What measures are necessary to prevent cross contamination 
between carcasses?
    33. In establishments that predominantly slaughter cattle 30 months 
of age and older. are additional sanitation requirements necessary to 
prevent edible portions of carcasses from being contaminated with SRMs?

D. Equivalence

    In response to the FSIS rule that prohibits SRMs and non-ambulatory 
disabled cattle for use in human food, FSIS has received several 
comments from countries that consider themselves ``BSE free'' 
requesting that the Agency exempt countries recognized as ``BSE free'' 
or ``provisionally free'' from the requirements of the interim final 
rule. According to these countries, their BSE status provides the same 
level of protection against BSE that is achieved domestically by the 
provisions in the FSIS interim final rule. Therefore, these countries 
assert that their BSE status is an ``equivalent sanitary measure.''
    Meat and meat products exported to the United States from another 
nation must meet all sanitary standards applied to meat and meat 
products produced in the United States. The United States makes 
determinations of equivalence by evaluating whether foreign food 
regulatory systems attain the appropriate level of protection provided 
by our domestic system. Thus, while foreign food regulatory systems 
need not be identical to the U.S. system, they must employ equivalent 
sanitary measures that provide the same level of protection against 
food safety hazards as achieved domestically.
    Currently, the prohibition on the use of materials designated as 
SRMs in FSIS'' SRM rule applies to all such materials, regardless of 
the BSE status of the country of origin, as does the prohibition on the 
slaughter of non-ambulatory disabled cattle. However, as discussed 
earlier in this document, the OIE standards for trade in bovine-derived 
products, including meat and meat products, take into consideration the 
BSE risk status of a country or zone.

[[Page 42300]]

Therefore, FSIS is evaluating whether the Agency should consider a 
country's BSE risk when determining whether a country has implemented 
equivalent sanitary measures to those required by the United States to 
prevent human exposure to the BSE agent. Issues under consideration by 
FSIS include whether the Agency should develop and apply its own 
standards for determining a country's BSE risk; whether it should adopt 
and apply existing standards; and whether FSIS should conduct its own 
evaluation to determine a country's BSE risk for purposes of 
determining equivalence or whether it should rely on a third party 
evaluation.
    Therefore, FSIS requests comments on the following questions:
    34. Should FSIS provide an exemption for ``BSE free'' countries or 
countries with some other low-risk BSE designation?
    35. If FSIS were to exempt ``BSE free'' countries from the 
provisions of the SRM rule, what standards should the Agency apply to 
determine a country's BSE status?
    36. How would FSIS determine that country meets such standards? For 
example, should it rely on third party evaluations, such as the OIE, or 
conduct its own evaluation?
    In the interim final rule on prohibited cattle material in human 
food and cosmetics published in the Rules and Regulations section of 
this Federal Register, FDA also has requested comments on standards to 
apply when determining another country's BSE status, providing an 
exemption for ``BSE-free'' countries, and how to determine that 
countries meet any standards that might be developed. FDA will work 
with USDA in developing a harmonized U.S. position for dealing with 
these issues.

VII. Submission of Public Comments

    APHIS, FSIS, and FDA invite public comment on the issues and 
questions presented in this ANPRM. To facilitate each agency's review 
of comments, we ask that comments be submitted to the agency (APHIS, 
FSIS or FDA) that is seeking comment on the particular question the 
comment addresses. The agency or agencies that wish to receive comments 
on a particular issue are identified before each question or set of 
questions in sections V or VI. Comments should be submitted to all 
agencies only when comments address general questions or issues 
applicable to all agencies. Comment submissions should include the 
appropriate agency docket number(s). Please refer to the docket numbers 
and instructions for submitting comments in the ADDRESSES section at 
the beginning of this document.
    Please also note that the comment periods established by each 
agency are different. FDA intends to issue a proposed rule on animal 
feeds subsequent to publication of this ANPRM. To facilitate FDA's 
consideration of those comments in developing the proposed rule, please 
submit comments specific to the FDA issues and questions to FDA prior 
to close of the 30-day comment period listed for FDA in the DATES 
section of this document. APHIS and FSIS will accept comments for 60 
days, as provided in the DATES section of this document.

    Authority: 7 U.S.C. 8301-8317; 21 U.S.C. 321, 342, 343, 348, 
371, and 601-695.

    Done in Washington, DC, this 8th day of July, 2004.
Bill Hawks,
Under Secretary, Marketing and Regulatory Programs, USDA.
Elsa Murano,
Under Secretary, Food Safety, USDA.

    Dated: Done in Washington, DC, this 8th day of July, 2004.
Lester M. Crawford,
Acting Commissioner of Food and Drugs.
[FR Doc. 04-15882 Filed 7-9-04; 11:00 am]
BILLING CODE 3410-34-P; 3410-DM-P; 4160-01-P