UNITED STATES DEPARTMENT OF AGRICULTURE
FOOD SAFETY AND INSPECTION SERVICE
WASHINGTON, DC FSIS NOTICE
28-04
5/20/04
FSIS SAMPLE COLLECTION FROM CATTLE CONDEMNED DURING ANTE-MORTEM
INSPECTION FOR THE BOVINE SPONGIFORM ENCEPHALOPHATHY (BSE) SURVEILLANCE
PROGRAM
NOTE: FSIS PERSONNEL ARE NOT TO IMPLEMENT THE SAMPLE COLLECTION
PROCEDURES IN THIS NOTICE UNTIL JUNE 1, 2004
1.
PURPOSE
This notice contains updated information from FSIS Notice 18-03
, dated
5/27/03. That notice expires on 6/1/04. In light of recent events, FSIS
will be collecting brain samples from cattle at federally-inspected
establishments for the purpose of BSE testing. Therefore, FSIS is
issuing new sample collection, documentation, and shipping procedures to
inspection program personnel, particularly Public Health Veterinarians
(PHVs). Specifically trained FSIS PHVs will collect the brain samples.
The samples will be shipped to the USDA Animal and Plant Health
Inspection Service (APHIS) National Veterinary Services Laboratory
(NVSL) in Ames, Iowa, or another APHIS-designated laboratory.
2.
BACKGROUND
BSE is a reportable disease in the United States. In cooperation with
FSIS, APHIS leads an ongoing, comprehensive, interagency surveillance
program for BSE. Using the Federal Meat Inspection Act, 21 U.S.C. 603,
part of the FSIS ante-mortem examination and inspection procedure will
include the collection of a brain sample from cattle. For the first
time, FSIS PHVs will collect brain samples from cattle that are
condemned during ante-mortem inspection at federally-inspected
establishments. The APHIS Area Veterinary Inspector-in-Charge (AVIC)
will focus upon sample collection activities by APHIS at locations other
than federally-inspected establishments (e.g., rendering operations and
on-farm). FSIS PHVs will take samples from all cattle showing signs of
central nervous system (CNS) disorders, as well as the types of cattle
that may be at higher risk for being infected with the agent believed to
cause BSE, based, in part, on European data. These cattle, while at
federally-inspected establishments, are under the control of FSIS and
will have the brain sample collected either by the trained FSIS PHV or
an available APHIS technician with direct supervision and oversight by
the FSIS PHV.
Under FSIS Notice 18-03 FSIS contacted APHIS whenever specific cattle
were presented for ante-mortem inspection (e.g., cattle exhibiting CNS
symptoms). The notice also stated that an APHIS veterinarian will be
responsible for collecting the brain sample. When FSIS Notice 18-03
expires on June 1, 2004, APHIS will no longer collect the brain samples.
As instructed in this notice, FSIS personnel will collect brain samples
from ante-mortem condemned cattle, and especially from any cattle
exhibiting CNS symptoms, and will submit the samples to APHIS for
analysis. APHIS will no longer collect brain samples at FSIS-inspected
establishments.
3.
Should the FSIS PHV have an awareness meeting with the
establishment regarding the BSE testing process?
1.
Yes, before June 1, 2004, the FSIS PHV needs to meet with
the establishment to explain the procedure for the
collection of brain samples for BSE testing. At this
meeting, the FSIS PHV and management should discuss:
1.
the FSIS procedures set forth in this notice.
2.
how the establishment will ensure that ante-mortem
condemned cattle will be segregated from other cattle,
3.
whether the establishment will remove the head under
the direct supervision of the FSIS PHV, or whether the
FSIS PHV will have to remove the head,
4.
whether the establishment has existing arrangements
with APHIS under which the establishment delivers the
carcass to deadstock facilities, renderers, or other
animal disposition facilities so that APHIS can
collect brain samples. If so, the FSIS PHV is to
notify his or her District Office (DO).
5.
how the establishment will hold the ante-mortem
condemned animal (head and carcass) until removal from
the premise,
6.
how the establishment will dispose of the condemned
carcass (i.e., picked up by renderer, sent to a
landfill) and that the establishment is to maintain
records, as required in 9 CFR 320.1, regarding the
disposition of the condemned carcasses, and
7.
that the establishment may obtain additional
information about the sampling program from
http://www.aphis.usda.gov/lpa/issues/bse/bse.html.
2.
In a memorandum of interview, the FSIS PHV is to document who
was present at the awareness meeting, the date and time of the
meeting, what was discussed and decided regarding the issues
above, and any documents that were shared with management.
3.
The FSIS PHV is to maintain a copy of the memorandum of
interview in the official government file, provide a copy to
the plant management, and electronically mail a copy to the
APHIS AVIC.
4.
Who, in FSIS, will collect the brain tissue sample?
Trained FSIS PHVs will collect the sample from ante-mortem
condemned cattle. FSIS, along with APHIS, will sponsor a special
sample collection training session prior to June 1, 2004. Most
establishments with a history of having ante-mortem condemned
cattle will soon have a trained FSIS PHV on-site. Other
establishments, such as those in remote locations, may have a
trained FSIS PHV come to the establishment to collect samples.
Still, other establishments may have an APHIS technician on-site
to collect samples. However, the APHIS technician will, for
purposes of brain sample collection, collect the sample with
direct supervision by the FSIS PHV.
5.
What cattle will be sampled by FSIS for BSE surveillance purposes?
1.
All ante-mortem condemned cattle at federally-inspected
establishments will have a portion of the brain collected by
the specially trained FSIS PHV, except for 1) cattle that
are 400 pounds or less (which may be referred to as veal
calves ) with characteristics of immature cattle, condemned
by the FSIS PHV but that do not exhibit CNS signs, and 2)
cattle condemned on ante-mortem inspection that the
establishment elects to have treated pursuant to 9 CFR
309.13(b).
2.
The FSIS PHV or the APHIS technician under the supervisory
authority of the FSIS PHV, will collect the brain sample
from cattle condemned by the FSIS PHV during ante-mortem
inspection at the federally-inspected establishment. Cattle
off-loaded from the transport vehicle onto the premises of
the federally-inspected establishment, whether dead or
alive, will be sampled by the FSIS PHV for BSE after the
cattle have been condemned during ante-mortem inspection. In
addition, cattle passing ante-mortem inspection but later
found dead prior to slaughter will be condemned and be
sampled by the FSIS PHV. The FSIS PHV is to make all final
disposition decisions regarding whether cattle should be
condemned in accordance with 9 CFR part 309.
6.
What information will the FSIS PHV maintain regarding the identity
of condemned cattle?
The FSIS PHV will ensure the collection and documentation of all
animal identification associated with cattle condemned during
ante-mortem inspection that are to be sampled by FSIS. The FSIS
PHV is to attach the U. S. Condemned tag cattle condemned during
ante-mortem inspection in accordance with 9 CFR 309.13. The FSIS
PHV is to also ensure that available records associated with the
documentation of the ownership of the cattle are maintained along
with a file on each BSE-sampled animal. This documentation will
facilitate trace back in the event that the sample result is
positive for BSE. The documentation should include records in
accordance with 9 CFR 320.1. NOTE: The slaughter establishment
should not be considered the owner of the animal as a default.
Once the brain sample has been collected from the head and all
animal identification has been recorded and removed, the head and
remainder of the animal are to be disposed of in accordance with 9
CFR 314. The establishment is to ensure that insanitary conditions
do not result from inappropriate holding of the head and carcass
while the condemned material is awaiting pick-up by a renderer or
by other means of transport or disposal.
7.
What is the process for ensuring that the condemned cattle (e.g.,
the carcass and head minus the brain sample) are removed from the
establishment?
The FSIS PHV should ensure that insanitary conditions are not
created by the presence of the condemned cattle (9 CFR part 416).
The establishment is responsible for the disposal of the condemned
cattle in accordance with 9 CFR part 314. In cases in which the
establishment cannot obtain transport services for removal of the
condemned cattle in a timely manner, the establishment should
contact the APHIS AVIC. Also, the establishment is to maintain
records regarding the disposition of the condemned cattle in
accordance with 9 CFR 320.1.
8.
How will the cattle be handled in order for the FSIS PHV to
collect the brain tissue sample?
1.
If condemned cattle are alive, the establishment is required
to humanely euthanize the cattle, in accordance with 9 CFR
309.13. The head should be removed as quickly as possible in
order to collect the brain sample. If the establishment does
not make arrangements to remove the head, the FSIS PHV
should notify the Front-line Supervisor that the brain
sample collection will need to be taken as a priority over
other ante-mortem or post-mortem procedures.
2.
The brain sample should be collected either in the inedible
area of the establishment or other area set aside for such
collection in which edible product cannot become adulterated
due to the creation of an insanitary condition. The
establishment, APHIS technician, and FSIS personnel are to
take proper sanitary measures before returning to edible
areas of the establishment after brain sample collection, in
accordance with 9 CFR 416.5.
9.
Will the FSIS PHV receive special sample boxes and instructions
for shipping the sample?
1.
Establishments with a history of high ante-mortem
condemnation rates for slaughter will be identified by FSIS
and the FSIS PHV at these establishments will receive
multiple special sample boxes and shipping instructions from
APHIS. Establishments without a history of high ante-mortem
condemnation rates for slaughter will be identified by FSIS
and the FSIS PHV at these establishments ultimately will
receive sample boxes and shipping instructions from APHIS.
The brain samples will be shipped to the APHIS NVSL or other
designated laboratory, but not to an FSIS laboratory. (See
Attachment 1
).
2.
After June 1, 2004, if cattle are condemned at ante-mortem
inspection and the trained FSIS PHV does not have a special
sample box and shipping instructions, the brain sample is to
be collected by the FSIS PHV and put into a plastic bag and
securely stored in a cooler (not a freezer). The sample is
not to pass through or to be stored in areas of the
establishment where edible product is produced. This may
mean that the sample has to be stored under refrigeration
outside of the official establishment. If there is no
trained FSIS PHV or APHIS technician immediately available
to collect the brain sample, the FSIS PHV should have the
establishment save the head, brain intact, and place the
head in a cooler (not a freezer) to reduce post-mortem
autolysis of the brain. The head should be placed into a
plastic bag and securely stored as explained above.
10.
What is included in the special sample box and shipping instructions?
The special sample box from APHIS will include a sample collection
kit (e.g., equipment to obtain the brain sample, a tube for
placing the packaged sample within the shipping container, and
identifying labels to affix to the sample). The FSIS PHV is to
enter the U.S. Condemned tag number onto the APHIS-supplied
forms. FSIS should record any APHIS identifying bar code labels
onto the FSIS condemnation certificate. The shipping container
will be picked up by FedEx, using the APHIS contract for overnight
shipping. If there is a problem with the FedEx pickup of BSE
samples, the FSIS PHV should contact the DO. The DO will contact
the APHIS contact person responsible for the APHIS FedEx contract.
NOTE: In situations where the last FedEx pick-up for the day has
been missed or the sample is collected on a day when FedEx does
not pick up, store the samples as discussed in paragraph IX. B.
until the next available FedEx pick up day.
11.
What information will the FSIS PHV identify on the condemnation
report and the APHIS sample request form?
The FSIS PHV will continue to complete the condemnation form, FSIS
Form 6000-13, (Certification of Ante-mortem or Post-mortem
Disposition of Tagged Animals) and FSIS Form 6150-1
(Identification Tag Ante-mortem). The FSIS PHV should pay
special attention when providing a full description of the reason
for the condemnation on FSIS Form 6000-13 and fully fill out FSIS
Form 6150-1 (i.e., identification, breed, sex, reason for tag, and
clinical signs). In addition, the FSIS PHV is to include similar
information on the APHIS sample request form, including the
estimated age of the cattle (see
http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=/ofo/tsc/index.htm.)
The FSIS PHV should give special consideration to any age
documentation that accompanies cattle to the federally-inspected
establishment, in lieu of a dentition determination.
12.
How will sample results be reported?
APHIS NVSL will report the sample result to the establishment.
FSIS is working with APHIS on a process to also include the FSIS
PHV in the reporting of the sample result.
13.
Will the FSIS PHV collect samples from healthy-appearing cattle
that are not condemned?
The details regarding the testing of healthy appearing cattle 30
months of age and older by FSIS or APHIS is still under
discussion. This group of cattle is much less likely to
demonstrate BSE infectivity than those that show CNS symptoms or
that have died on-farm or otherwise, or that are ante-mortem
condemned. Thus, the details for the portion of the BSE
surveillance program involving healthy-appearing cattle will issue
in a separate FSIS notice at a later date.
14.
What form will the FSIS PHV complete to record each sample taken?
The FSIS PHV will complete FSIS Form 5000-9, BSE Sampling Tracking
Sheet located in MS Outlook, Public Folders, All Public Folders,
Agency Issuances, Forms, FSIS 5000 series to report every sample
collected. To facilitate APHIS reimbursement for the sample, the
FSIS PHV will send a hard copy of the Form to the Financial
Processing Center, Financial Management Division.
Refer questions to the Technical Assistance and Correlation
Division, Technical Service Center at (402) 221-7400.
Philip S. Derfler /s/
Deputy Administrator
Office of Policy, Program, and Employee Development
DISTRIBUTION: Inspection Offices; T/A Inspectors; Plant Mgt; T/A Plant
Mgt; TRA; ABB; TSC, Import Offices NOTICE EXPIRES: 6-01-05 OPI: OPPED
Attachment 1
Designated Laboratories for BSE Sample Submission
State where sample was collected
Designated laboratory
Arizona, California, Nevada
California Animal Health and Food Safety Lab System
University of California Davis, CA
Colorado, Kansas, Missouri, Nebraska, North Dakota, South Dakota, Utah,
Wyoming
Colorado State University Veterinary Diagnostic Lab
Ft. Collins, CO
Arkansas, Louisiana, New Mexico, Texas
Texas Veterinary Medical Diagnostic Laboratory
College Station, TX
Minnesota (or NVSL), Wisconsin
Wisconsin Animal Health Laboratory
Madison, WI
Idaho, Montana, Oregon, Washington
Washington State University Animal Disease Diagnostic Lab
Pullman, WA
Alabama, Florida , Georgia, Mississippi, North Carolina, Oklahoma, South
Carolina, Tennessee, Virginia
Athens Diagnostic Laboratory, College of Veterinary Medicine
University of Georgia; Athens, GA
Connecticut, Delaware, Maine, Maryland, Massachusetts, Michigan, New
Hampshire, New Jersey, New York, Pennsylvania (all Pennsylvania), Rhode
Island, Vermont
NY State College of Veterinary Medicine
Veterinary Diagnostic Laboratory, Cornell University
Ithaca, NY
Alaska, Hawaii, Illinois, Indiana, Iowa, Kentucky, Minnesota (or WI),
Ohio, Puerto Rico, West Virginia
USDA, APHIS, National Veterinary Services Laboratory (NVSL)
Ames, IA
http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=/oppde/rdad/fsisnotices/28-04.htm
TSS
