[Federal Register Volume 69, Number 134 (Wednesday, July 14, 2004)]
[Proposed Rules]
[Pages 42288-42300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-15882]
[[Page 42287]]
-----------------------------------------------------------------------
Part III
Department of Agriculture
-----------------------------------------------------------------------
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
-----------------------------------------------------------------------
Department of Health and Human Services
-----------------------------------------------------------------------
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
[[Page 42288]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 42289]]
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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