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From: TSS (
Date: October 21, 2004 at 7:53 am PST

-------- Original Message --------
Date: Thu, 21 Oct 2004 09:18:35 -0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy

##################### Bovine Spongiform Encephalopathy #####################





The Food Safety and Inspection Service (FSIS) is issuing this notice to
provide answers to questions FSIS personnel have asked regarding FSIS'
BSE surveillance sampling program.

1. Electronic Animal Disposition Reporting System (eADRS) and
Performance- Based Inspection System (PBIS)

A. Question: What does an FSIS Public Health Veterinarian (PHV)
document in eADRS when non-ambulatory disabled cattle are
euthanized at the election of the establishment? Examples would be
when the plants humanely euthanize an animal prior to the arrival
of a PHV, or when an animal becomes non-ambulatory after
antemortem inspection has been conducted?

Answer: In such cases, the antemortem disposition would be "dead,"
and the PHV records this in eADRS under "deads". The category
"non-ambulatory (plant condemned)" is no longer available for
cattle in eADRS. Also, in such cases, the PHV may write "Dead
(Plant rejected and euthanized)" in the "Diagnosis/Condition"
column of FSIS Form 6000-13, Certificate of Antemortem or
Postmortem Disposition of Tagged Animals.

B. Question: Does the PBIS system schedule the brain sample
collection for BSE testing?

Answer: No. FSIS personnel collect samples in accordance with FSIS
Notices 28-04 and 29-04.

2. Alternative Sampling -- Animal and Plant Health Inspection Service
(APHIS) Central Sample Collection Point

A. Question: What are the animal identification collection and
documentation procedures for cattle sampled under an accepted
"alternative program" (APHIS central sample collection point)?

Answer: Normal documentation procedures apply, including recording
the condemned tag number and all animal identification (e.g.,
eartag, backtag) on FSIS Form 6150-1 (Identification
Tag-Antemortem). However, in this case the animal identification
tags or devices will remain on the animal or handled in accordance
with an accepted alternative method. Condemned tags should be
removed prior to transport and after the carcass has been
denatured in accordance with 9 CFR 314.

B. Question: What responsibility does the FSIS PHV have to provide
information to plant management for cattle sampled under an
acceptable alternative program (APHIS central sample collection

Answer: The FSIS PHV´s responsibility is to supply plant
management with copies of FSIS Form 6000-13, Certificate of
Antemortem or Postmortem Disposition of Tagged Animals, that
includes the condemned tag number. The establishment may also
request to make copies of FSIS Form 6150-1. The establishment may
use this information to fulfill the expectation of FSIS Notice
29-04 concerning alternative programs to ensure that the animal
identification information and condemned tag number (although not
physically attached) remain associated with the animal.

3. State, Talmadge-Aiken (T/A), and Custom-Exempt Establishments

A. Question: How is the sampling handled at T/A plants?

Answer: FSIS will perform sampling in TA plants. If sample
collection is needed, the state coordinator should contact the
District Office (DO).

B. Question: How is the sampling handled at State plants?

Answer: State plants should contact the State Area
Veterinarian-in-Charge (AVIC) for sample collection. Any
alternative programs for sampling off-premises must be consistent
with FSIS Notice 29-04.

C. Question: At federally-inspected establishments, who is
responsible for collecting brain samples from animals designated
"for custom slaughter" and that are non-ambulatory disabled cattle
or cattle that exhibit Central Nervous System (CNS) signs?

Answer: When an establishment´s schedule of operations indicates
that the establishment is operating under custom exempt, those
animals are exempt from the inspection requirements of the Federal
Meat Inspection Act (FMIA). Because custom exempt cattle that are
non-ambulatory disabled or that exhibit CNS signs are unfit for
food, inspection program personnel who observe cattle with these
signs being slaughtered for food are to detain the carcass and
head in accordance with FSIS Directive 8410.1, rev 2. Inspection
program personnel also are to contact the DO.

The DO will assign a PHV to collect and submit a brain sample for
BSE testing. In addition, the PHV is to notify the OPEER Regional
Manager through supervisory channels.

4. IV. Sample Collection

A. Question: How will personnel be dispatched to collect samples
at federally- inspected establishments?

Answer. District Managers will handle this within their districts
according to staffing needs.

B. Question: Does the PHV have to be present when the head is removed?

Answer: While it is preferable that the PHV be present at the time
of head removal, some situations (e.g., non-ambulatory disabled
cattle that have been euthanized by the plant) may require removal
of the head prior to the arrival of a PHV. The process for
removal, storage, and control of the head and carcass denaturing
should be decided during the awareness meeting with plant
personnel if it is anticipated that removal of the head in the
absence of the PHV may be necessary. The establishment´s process
should also ensure that sufficient controls are in place to
maintain the identity of the animal.

C. Question: Are instruments used only to harvest the sample
required to be sanitized?

Answer: No, but thorough washing is recommended. It would be
preferable that dedicated or disposable instruments be used to
harvest samples for BSE testing.

D. Question: How is the determination made that the animal is 400
lb. or less?

Answer: The PHV must rely on his or her judgment, expertise, or
any other resources (e.g., records or actual weighing of animal)
to determine the approximate weight of the animal.

E. Question: Are dead calves (i.e., less than 400 lbs.) sampled?

Answer: No, because such animals are not part of the high-risk
population identified by APHIS.

F. Question: Who is responsible for sampling dead cattle
off-loaded onto plant-owned property that is adjoining to, but not
considered part of, the "official premises"?

Answer: Such cattle would be subject to sampling by APHIS.

G. Question: What is considered to be "presented for antemortem

Answer: Live cattle that are off-loaded from transportation
vehicles are considered to be presented for inspection and,
therefore, are to be tested under FSIS Notice 28-04, where
applicable. Dead cattle that are off-loaded to facilitate the
off-loading of live animals, but that will be promptly re-loaded
onto the transport vehicle, are not subject to sampling by FSIS.

H. Question: Does the head always have to be removed when
harvesting samples?

Answer: PHVs have been trained to remove the head in order to
collect the sample. If a plant is exposing the brain stem for
sample collection by the PHV, the PHV will determine whether a
sample can be adequately collected. Although PHVs can work with
the plant to determine other efficient and suitable methods,
decisions on the adequacy of sample collection procedures are the
responsibility of the PHV.

I. Question: How is BSE sampling handled at small plants where
there is no PHV?

Answer: The PHV responsible for final disposition in that plant
should be contacted. If the animal is condemned, the DO will
follow its procedures for arranging for sample collection by a
trained PHV.

J. Question: What procedures should be followed for head removal
after an animal is U. S. condemned and euthanized?

Answer: It is recommended that the establishment remove the head
for FSIS sampling as soon as possible. FSIS sampling (including
head removal if not performed by the establishment) may take
precedence over other antemortem or postmortem procedures.

K. Question: Can the plant use the suspect pen for sampling?

Answer: The plant can use the suspect pen, provided humane
handling and inspection of other animals in the suspect pen is not
affected. Regardless of where the sampling is performed, sanitary
conditions must be maintained.

5. Carcass Disposal

A. Question: If the plant takes the carcasses to a landfill, whose
jurisdiction does this fall under?

Answer: This will be the responsibility of state or local
authorities. FSIS personnel need only verify through plant records
that the carcasses did in fact go to the landfill.

B. Question: Can the establishment dispose of the carcass prior to
receiving lab results?

Answer: Yes. Because the animal was condemned at antemortem
inspection, there is no requirement for establishments to hold
carcasses. FSIS is recommending that establishments make
arrangements to confirm negative results prior to these carcasses
being rendered. This would not be an issue for carcasses going to
incineration, alkaline digestion, or a lined landfill. Also, local
sanitary codes are applicable.

C. Question: Can establishments remove carcasses from the premises
outside of the official hours of operation without being sampled?

Answer: Yes. There are no regulations which would prohibit this
from occurring. However, establishments remain subject to the FMIA
denaturing requirements for such carcasses (21 USC 641). FSIS is
committed to sample all available carcasses during established
hours of operation.

6. Sample Integrity

A. Question: Is the PHV responsible for determining whether the
sample is of acceptable quality (i.e., whether autolysis has not
occurred) before submitting a sample to the laboratory?

Answer: The PHV is responsible for the timely collection of and
proper shipping of collected samples to the laboratory. PHVs are
not responsible for making the determinations about the quality of
the collected samples for their diagnostic suitability. If the
collected samples have to be held prior to shipping they are to be
held in cold storage, not frozen.

B. Question: When extracting the brain stem, what distance above
and below the "V" (obex) do you allow?

Answer: The cut should be made approximately ½ to 1 inch above and
below the obex.

C. Question: If the obex is unavailable, is there any other tissue
which can be submitted for testing?

Answer: No, the obex is the only location we are currently testing.

D. Question: Can the obex be moistened to facilitate its entry
into the tube?

Answer: No.

E. Question: Should the sample be washed/rinsed to remove blood

Answer: No. APHIS prefers that blood clots are removed by hand and
the sample be blotted with a paper towel.

F. Question: Is it necessary to attach an FSIS security seal to

Answer: No.

G. Question: Because samples cannot be stored or passed through
areas in which there is edible product, how can establishments
store these samples?

Answer: Plants may have a dedicated refrigerator for samples in
the inspection office or elsewhere that can be reached without
passing through edible areas. Different options should be
discussed during the awareness meeting, and could include, for
example, use of a portable cooler.

H. Question: What if the brain stem is mutilated due to the method
used to euthanize the animal?

Answer: Submit the sample and write on the sample form that the
sample was mutilated prior to collection.

7. Laboratory Results

A. Question: How long does it take to receive results after the
brain sample is submitted?

Answer: The laboratories generally report the results 36 to 48
hours after the sample is shipped.

B. Question: Who will receive the results?

Answer: A report of the test results will be sent to the
submitter, the AVIC, and the establishment, if requested.

C. Question: Will the results of the BSE test be posted on
Laboratory Electronic Application for Results Notification (LEARN)?

Answer: No, not at this time.

D. Question: Other than reporting positive results, what will the
laboratory report state?

Answer: The laboratory report may state one of the following: "Not
Detectable" which indicates that the sample was tested and the
results were negative; "Location" which could mean that the sample
appeared to be a brain stem, but could not be identified as the
obex; or "Not Tested" or "Not Testable" which means that the
sample could not be recognized as a brain stem or that it was

E. Question: How may a carcass be disposed of when a result of
"Not Tested" or "Not Testable" is received?

Answer: If a test was not conducted, plants may dispose of such
carcasses by any available means such as inedible rendering,
incineration, alkaline digestion, or movement to lined landfills
in accordance with state or local codes.

8. Documentation

A. Question: What if the name and address of the owner are not
available at the time of sampling?

Answer: The sample should be collected and submitted as soon as
possible. The missing information can be sent at a later date when
it becomes available (this information should be sent regardless
of whether the sample results are positive or negative). This
information should be made available in accordance with the
recordkeeping requirements in 9 CFR part 320.

B. Question: Is it sufficient to identify a broker or auction
house as the owner of the animal?

Answer: Every attempt should be made to attain the actual
producer´s name and address. However, if that cannot be obtained,
identify a broker or auction house as the owner.

C. Question: Is filling out FSIS Form 6000-13 mandatory?

Answer: No. For antemortem condemned cattle, complete FSIS Form
6000-13 when requested by plant management. Consistent with their
training for collection of BSE samples, PHV´s are to maintain a
file on each sampled animal. PHVs can use either a Form 6000-13,
6200-14, or 6150-1 to capture the condemnation Z-tag number of
sampled animals. For plants with alternative procedures for
off-site sampling, FSIS Form 6000-13 may be requested to
facilitate correlations with the condemnation Z-tag number.

D. Question: Should animal identification (e.g., eartags,
backtags) be collected and saved until sample results are received?

Answer: Yes, they should be saved in a plastic bag in association
with the dedicated file. Do not send these items with the sample.

E. Question: How should "deads" be recorded in the "Clinical
Signs" section of the APHIS form, Veterinary Services (VS) Form
10-4 - Supplemental Form?

Answer: Check the box marked "other" at the bottom-right portion
of this section, and write in "dead" below it.

F. Question: Is the barcode placed on the copy of the condemnation
form, or on the original?

Answer: On the copy (second sheet) that is maintained by FSIS. The
original goes to the establishment.

G. Question: Is it mandatory to complete FSIS Form 5000-11, BSE
Sampling Tracking Sheet?

Answer: Use of FSIS Form 5000-11 by PHVs who collect BSE samples
is mandatory. The only acceptable version of this form is in Form
Flow. The form is only to be used when FSIS personnel actually
collect the sample. PHVs are to provide complete and accurate
entries of all items on FSIS Form 5000-11. PHVs are to indicate
the appropriate age to the best of their abilities. The forms
should be either mailed or faxed to the Financial Processing
Center (FPC). PHVs are not to submit duplicates because this would
require FPC to verify the forms twice. Whether by mail or fax,
PHVs can submit Form 5000-11 to the FPC on weekly basis. The form
does not have to be submitted daily. Also, the PHV is not to
submit other forms (e.g., FSIS Form 6000-13 or VS Form 10-4) to
FPC. PHVs that collect a sample during a reimbursable overtime
period are to note this in the provided check box, not in the
remarks section. Established forms or timesheets should continue
to be completed for regular and overtime hours.

H. Question: Should a copy of FSIS Form 5000-11 be sent with the

Answer: No.

I. Question: Can unused sets of barcodes be utilized at a later date?

Answer: Yes, unused entire sets of barcodes can be utilized for
future samples. Since each set represents a unique number, use one
set of barcodes for each sample. Do not use incomplete sets.
Destroy incomplete sets.

9. Sample Shipping

A. Question: If a sample is collected on a Saturday, Sunday, or
holiday, should the sample be held?

Answer: Yes, the sample should be held until the next available
Federal Express pick-up.

B. Question: When a sample is sent, will the laboratory
automatically return the shipping container?

Answer: National Veterinary Services Laboratory (NVSL) will
automatically return the shipping container. However, the other
labs do not provide automatic returns.

Therefore, sufficient sampling supplies should be maintained by
ordering through NVSL (Ames, IA).

C. Question: Should unused tubes be saved?

Answer: Yes. They can be used for subsequent sampling.

D. Question: What is the turnaround time on shipping containers
sent to NVSL?

Answer: Approximately five days. In an emergency, APHIS can ship

E. Question: Are the fax forms available for requesting overnight
delivery of shipping containers?

Answer: Yes. This form (BSE Kit and Instrument Order Form) is
available on Outlook "All Public Folders/OFO/Technical Service
Center/BSE Training Info."

F. Question: Can the same shipping container for samples from 2
different establishments be used?

Answer: Yes, as long as the paperwork and equipment (e.g., tubes)
are separate and properly identified.

Philip S. Derfler /s/

Assistant Administrator
Office of Policy, Program, and Employee Development

DISTRIBUTION: Inspection Offices; T/A Inspectors; Plant Mgt; TRA; ABB;
TSC; Import Offices NOTICE EXPIRES: 8/01/05 OPI: OPPED

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