Attachment 3 - VS Guidance 7800.1 Procedures for Sample Collection.pdf

U.S. DEPARTMENT OF AGRICULTURE

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service Veterinary Services

VS Guidance 7800.1

Bovine Spongiform Encephalopathy (BSE) Ongoing Surveillance Program

1. Purpose and Background

This document provides guidance for carrying out the procedures in the Animal and Plant Health Inspection Service (APHIS), Veterinary Services’ (VS) Bovine Spongiform Encephalopathy (BSE) Ongoing Surveillance Plan.

In August 2006, VS implemented the BSE Ongoing Surveillance Program. The BSE Ongoing Surveillance Program followed the Enhanced Surveillance Program, which VS operated from 2004 to 2006 following the detection of the first classical BSE case in a dairy cow imported from Canada in 2003.1 To date, VS has not detected a case of classical BSE in a U.S.-born animal and has detected only five (5) cases of atypical BSE in U.S. cattle (Bos taurus and Bos indicus). VS does not regard detection of classical BSE in a U.S. animal as likely as long as cattle and animal feed producers maintain effective mitigation measures, particularly restrictions on animal feed ingredients.

VS’ BSE Ongoing Surveillance Program monitors and assesses changes to the BSE status of U.S. cattle and provides mechanisms to detect BSE as early as possible. The plan is designed to meet or exceed World Organization for Animal Health (OIE) “Type B” surveillance standards, which are recommended for countries with negligible risk status for BSE. (The United States obtained negligible risk status for BSE from the OIE in May 2013.) The OIE “Type B” guidelines require surveillance that can detect one (1) case of BSE per fifty thousand (50,000) adult cattle with a 95 percent confidence level. VS’ BSE Ongoing Surveillance Plan, in comparison, is designed to detect a prevalence of one (1) BSE case per one million (1,000,000) adult cattle with a 95 percent confidence level. This represents a twenty-fold increase in sensitivity over OIE surveillance recommendations for negligible risk countries.

Detailed instructions and guidelines for the procedures used in the BSE Ongoing Surveillance Program can be found in VS’ “Procedures Manual: Bovine Spongiform Encephalopathy (BSE) Ongoing Surveillance Program.”

Note: Cattle and bovine are defined as Bos Taurus and Bos indicus in this document.

This guidance document represents the Agency’s position on this topic. It does not create or confer any rights for or on any person and does not bind the U.S. Department of Agriculture (USDA) or the public. The information it contains may be made available to the public. While this document provides guidance for users outside VS, VS employees may

1 BSE can be either classical or atypical. Classical BSE can occur when an animal consumes contaminated feed early in life. Atypical BSE occurs in older animals and is not generally associated with consumption of contaminated feed.

Its etiology is unclear, and it may arise spontaneously.

https://www.aphis.usda.gov/animal_health/monitoring_surveillance/bse-ongoing-surv-plan.pdf https://www.aphis.usda.gov/animal_health/monitoring_surveillance/bse-ongoing-surv-plan.pdf https://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_bse.htm https://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_bse.htm https://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_bse.htm https://www.aphis.usda.gov/animal_health/lab_info_services/downloads/BSE_Procedures_Manual.pdf not deviate from the directions provided herein without appropriate justification and supervisory concurrence.

2. Document Status

A. Review date: 10/01/2023.

B. This document replaces Veterinary Services Memoranda 579.2 and 580.16 and VS Bulletin 2014.03.

3. Reason for Reissuance

VS is reissuing this guidance to provide updated instructions for BSE surveillance and to reflect changes in procedure and structure.

4. Authority and References

A. Authorities (Code of Federal Regulations (CFR)):

7 CFR 371.4

B. References:

• BSE Ongoing Surveillance Plan

• Procedures Manual: Bovine Spongiform Encephalopathy (BSE) Ongoing Surveillance

Program

• FSIS - 9 CFR 310.22, Specified risk materials from cattle and their handling and disposition

• FDA - 21 CFR 589.2001, Cattle materials prohibited in animal food or feed to prevent the transmission of bovine spongiform encephalopathy.

• VS 17-146, USDA BSE Surveillance Submission Form

• VS 17-146A, :USDA BSE Surveillance Continuation Form

• VS 17-131, USDA BSE Surveillance Data Collection Form

• Food Safety and Inspection Service (FSIS) Directive 10,400.1, Sample Collection from

Cattle 12 Months of Age or Older that Display Central Nervous System Signs under the Bovine Spongiform Encephalopathy Ongoing Surveillance Program

5. Audience

VS employees and other State and Federal agencies.

6. Guidance https://www.ecfr.gov/cgi-bin/text-idx?SID=801439f860a47317ec616f8445dce581&mc=true&node=se7.5.371_14&rgn=div8 https://www.aphis.usda.gov/animal_health/monitoring_surveillance/bse-ongoing-surv-plan.pdf https://www.aphis.usda.gov/animal_health/lab_info_services/downloads/BSE_Procedures_Manual.pdf https://www.aphis.usda.gov/animal_health/lab_info_services/downloads/BSE_Procedures_Manual.pdf https://www.ecfr.gov/cgi-bin/text-idx?SID=b5e1205cfeddcdf269ac813bf2bde159&mc=true&node=se9.2.310_122&rgn=div8 https://www.ecfr.gov/cgi-bin/text-idx?SID=b5e1205cfeddcdf269ac813bf2bde159&mc=true&node=se9.2.310_122&rgn=div8 https://www.ecfr.gov/cgi-bin/text-idx?SID=9321c9123a60d35c4bb2eb4e41be7161&mc=true&node=se21.6.589_12001&rgn=div8 https://www.ecfr.gov/cgi-bin/text-idx?SID=9321c9123a60d35c4bb2eb4e41be7161&mc=true&node=se21.6.589_12001&rgn=div8 https://www.aphis.usda.gov/library/forms/pdf/VS_17_146.pdf https://www.aphis.usda.gov/library/forms/pdf/VS_17_146a.pdf https://www.aphis.usda.gov/library/forms/pdf/VS_17_131.pdf https://www.fsis.usda.gov/wps/wcm/connect/09bf6ed8-1e4b-4ef5-a3e1-fa454b116b8e/10400.1.pdf?MOD=AJPERES https://www.fsis.usda.gov/wps/wcm/connect/09bf6ed8-1e4b-4ef5-a3e1-fa454b116b8e/10400.1.pdf?MOD=AJPERES https://www.fsis.usda.gov/wps/wcm/connect/09bf6ed8-1e4b-4ef5-a3e1-fa454b116b8e/10400.1.pdf?MOD=AJPERES

A. Sampling Targeted Cattle for Surveillance

1) Targeted Subpopulations

Targeted subpopulations for the BSE Ongoing Surveillance Program include cattle (domestically derived or legally imported) from the following three (3) surveillance streams, as outlined in the OIE Terrestrial Animal Health Code: Clinical suspect, casualty (or emergency) slaughter, and fallen stock.

NOTE: Cattle less than twelve (12) months of age are exempt from testing and defined in this document by dentition as “all teeth that have erupted, both incisors and cheek teeth, are deciduous and none is loose.”

a. Clinical suspect:

1. Cattle one (1) year or older displaying behavioral or clinical signs consistent with BSE. These cattle have a high value regarding BSE surveillance activities. Make every effort to sample these cattle for BSE surveillance, regardless of the site where these animals are identified. Clinical suspects are generally found in three (3) locations:

i. Cattle on-farm or at any other location showing central nervous system (CNS) signs.

ii. Rabies-negative cases from public health laboratories.

iii. Cattle condemned by FSIS for “CNS signs” or “rabies”.

2. Cattle one (1) year and older with signs that are highly suspicious for BSE.

i. Cattle affected by illnesses that are refractory to treatment (including anorexia, loss of condition in spite of good appetite, pneumonia, decreased milk yield) and displaying progressive behavioral changes that are not of an acute nature (including apprehension, nervousness, excitability, aggression, head shyness, hypermetria, kicking when milked, difficulty in rising, excessive nose scratching, or hesitation at gates/barriers).

ii. Cattle displaying progressive neurological signs (or that displayed these signs prior to becoming recumbent) that cannot be attributed to infectious illnesses and are not responsive to treatment.

b. Casualty (or Emergency) Slaughter: Cattle over thirty (30) months of age that are nonambulatory, recumbent, or unable to rise or to walk without assistance;

cattle over thirty (30) months of age sent for emergency slaughter, or condemned at antemortem inspection for reasons other than CNS signs.

1. Cattle older than thirty (30) months that are condemned by FSIS at antemortem inspection for any reason other than “CNS signs” or “rabies.”

2. Cattle without a history of CNS signs for which sample collection occurs on-farm, at veterinary clinics, or at livestock sales or auction barns and that are dead or nonambulatory; or cattle at slaughter that have clinical signs other than CNS signs that may be associated with BSE. Provide as much clinical history as possible.

3. Cattle presented to veterinary diagnostic laboratories for necropsy or for ancillary diagnostics without a history of CNS signs.

4. Cattle from renderers or 3D/4D facilities (up to a maximum of five thousand (5,000)) that are dead, nonambulatory, or sick. Collection of clinical history is preferable for these samples but is not required (3D/4D facilities render meat from animals that are dead, down, diseased, or dying.).

NOTE: Casualty (or emergency) slaughter is a surveillance stream outlined in the OIE Terrestrial Animal Health Code. In the United States, FSIS does not permit “emergency” slaughter of cattle as the parts and carcasses of cattle slaughtered in the absence of an inspector are not to be used for human food (9 CFR 311.27). These cattle are classified by FSIS as Non-Ambulatory Disabled (NAD) and condemned.

c. Fallen Stock: Cattle thirty (30) months and older that are found dead on farm, or during transport to or at an abattoir.

1. Obtain a clinical history for these animals when possible.

2. Do not collect samples from dead cattle with known cause of death and history that do not meet the criteria for targeted subpopulations (for example, acute deaths from lightning strike or other acts of nature, gunshot, fire, and hypothermia).

2) If possible, observe cattle considered highly suspicious for BSE for at least two (2) weeks to determine if the condition is progressive. If improvement or recovery does not occur, ensure the suspect animal is humanely euthanized and submitted for testing.

3) When the owner has stated the animal has been exhibiting signs that are highly suspicious for BSE for the past two (2) weeks, record a good history regarding the cattle from which samples are submitted.

4) Submit samples from all cattle twelve (12) months of age and older identified as highly suspicious for BSE, regardless of site of presentation, to a designated National Animal Health Laboratory Network (NAHLN) laboratory for BSE testing.

a. Contact the appropriate designated laboratory (Appendix 1, Designated Laboratories for BSE Sample Submission) or the National Veterinary Services Laboratories (NVSL) to verify collection and shipping procedures for these suspicious cases.

b. Submit samples from rabies suspects to a BSE laboratory for testing only after samples from the animal are tested and found to be negative for rabies at a rabies laboratory.

B. Sample Collection Sites

Cattle in the targeted subpopulations may present at various locations. Thus, sample collection sites for the BSE Ongoing Surveillance Program include farms, public health and animal diagnostic laboratories, rendering establishments, 3D and 4D establishments, and slaughter establishments.

1) On-Farm

An Accredited Veterinarian, Federal or State Official (including animal health technicians and contractors), or other VS-approved individuals (for example, dead stock haulers) may collect on-farm samples. On-farm samples may have value to surveillance because the samples are often accompanied by significant historical information. Therefore, the VS District Office may use any qualified source for sample collection.

2) Veterinary Diagnostic Laboratories

Laboratory personnel should sample targeted cattle submitted for necropsy or fresh whole brain stems submitted to veterinary diagnostic laboratories for ancillary diagnostics. Such samples are often accompanied by historical information or background concerning clinical signs and are of high value to surveillance.

Note: Formalin-fixed tissue specimen will be tested only on a case-by-case basis.

3) Public Health Laboratories

Public health laboratory personnel should submit all samples from cattle one (1) year or older that have tested negative for rabies to a designated laboratory (Appendix 1) for BSE testing.

4) Slaughter Establishments

Cattle twelve (12) months or older condemned for CNS signs or rabies on antemortem inspection will be sampled for BSE.

Additionally, cattle thirty (30) months or older condemned during antemortem inspection by FSIS are eligible for sample collection at designated offsite sample collection facilities, which are facilities contracted by VS to collect samples from cattle condemned at antemortem inspection.

5) Facilities Contracted by VS to Collect Samples from Cattle Condemned at Antemortem Inspection (i.e., Offsite Collection Facilities).

At VS-contracted offsite collection facilities, VS-trained contractors can collect samples derived from animals presented for slaughter and condemned during antemortem inspection by FSIS. These contractors must communicate animal identification information (including FSIS condemnation tag number, i.e., the "Z tag"), clinical history, and condemnation codes to the contracted facility.

6) Rendering or 3D and 4D Facilities

A limited number of samples will be collected from targeted cattle presented to rendering or 3D and 4D facilities. Sample collection at these sites only occurs according to provisions of competitive contracts awarded by VS. (The AVICs for the areas where the facilities are located have copies of the awarded contracts.) These sites typically include cattle from a wide variety of sources, and samples collected at these sites represent the "fallen stock" surveillance stream. Obtain a clinical history for sampled animals whenever possible.

C. Sampling Procedures

Collect the brain stem, including the obex, using a brain tissue spoon or other acceptable device as described in the Procedures Manual. NVSL provides sampling spoons, tools, and shipping materials to sample collectors. All samples must be submitted as fresh tissue samples and not fixed in formalin. Submit fresh tissue samples to a designated NAHLN laboratory (Appendix 1) or as specified by NVSL.

Appendix 2 addresses personal safety and describes several precautions that generally apply when collecting brain tissue from cattle with CNS clinical signs.

D. Animal Identification

The collector maintains the identity of cattle tested for the BSE Ongoing Surveillance Program throughout the entire sample collection, submission, and testing process. If testing confirms an animal was infected with BSE, the animal's identification allows VS personnel to trace its origin.

The collector records all animal identification devices associated with the sampled animal on the BSE Surveillance Data Collection Form (VS 17-131). Animal identification devices include all brands, tattoos, ear tags, and back tags. Enter all identification information in the VSLS - BSE Module. Animal identification devices may remain intact on the carcass or may be collected along with a piece of ear tissue (at least dime-sized attached to the ear tag) in a labeled bag and maintained until test results are received for the animal. When appropriate, obtain digital pictures or drawings of brands and collect tissues containing tattoos. Back tags should be pulled off the hide rather than cut off so that the hair (attached to the back tag) includes the bulb, which can be DNA tested as needed.

E. Data Collection Requirements

The AVIC ensures that the sample collector and submitter completes all relevant fields on the USDA BSE Surveillance Submission Form (VS 17-146), Continuation Form (VS 17- 146A), and the USDA BSE Surveillance Data Collection Form (VS 17-131). The information is recorded through a tablet, a personal computer, or via the Web-based Veterinary Services Laboratory (VSLS) System – BSE Module. If electronic entry is unavailable, the submitter completes the forms by hand and submits them as instructed by the AVIC for data entry. It is essential that the data is entered completely and accurately as it is used in assigning samples to the appropriate OIE surveillance stream and in determining the epidemiological value of each sample to the BSE Ongoing Surveillance Program.

Specifically, the submitter must record:

1) The collection site and type to indicate where he or she collected the samples (slaughter plant, diagnostic laboratory, renderer, 3D/4D, etc.).

2) The name(s) of the collector and submitter.

3) The BSE referral number, if known.

4) The collection date.

5) The primary reason for submission and the individual determining this reason.

https://www.aphis.usda.gov/library/forms/pdf/VS_17_146.pdf https://www.aphis.usda.gov/library/forms/pdf/VS_17_146a.pdf https://www.aphis.usda.gov/library/forms/pdf/VS_17_146a.pdf https://www.aphis.usda.gov/library/forms/pdf/VS_17_131.pdf

NOTE: For cattle condemned for CNS signs during ante mortem inspection at slaughter, record the reason as “FSIS, CNS antemortem condemned cattle.”

6) Owner and slaughter site information.

7) Breed, age, and gender of the animal(s) sampled.

8) The FSIS condemnation tag (Z tag number). Enter the Z tag number as an FSIS condemnation tag or animal ID. Do not enter it in the comments section.

9) All other identification devices associated with the animal using the appropriate identification type for each device.

10) Identify all applicable clinical signs and answer the questions regarding the progressive nature of the animal’s condition and the animal’s response to treatment (if known).

NOTE: If the condition did not respond to treatment, the appropriate response is Yes; if the condition did respond to treatment, the appropriate response is No.

F. Communication and Reporting of Test Results

1) Communication from the sample submitter to the designated NAHLN laboratory (see Appendix 1):

a. The sample submitter notifies the appropriate NAHLN laboratory of incoming samples via telephone, email, or any other approved electronic method (including VSLS).

b. The sample submitter must verify, via the overnight contract delivery service tracking system, sample delivery to the designated NAHLN laboratory.

2) Communication from NVSL and the designated NAHLN laboratory:

a. Not Detected - The day the rapid screening tests are completed and all animals tested in the lot are reported as “Not Detected," the designated NAHLN laboratory transmits a copy of these test results to the submitter, the AVIC, and State animal health official. If requested, a copy will also be transmitted to the appropriate management at the collection site.

b. Initial Inconclusive Test - The designated NAHLN laboratories report any initial “Inconclusive” results to NVSL. Contact attempts will be made in the following order until contact with NVSL is made:

1. The NVSL Director.

2. The NVSL Associate Director.

3. The Diagnostic Bacteriology and Pathology Laboratory director or head of the Pathology Section.

Do not make other contacts or report test results from the initial reactor lot until completing the repeat testing. If either of the repeat tests is above the negative cutoff, the screening test is considered “Inconclusive.”

c. Repeat Testing on Inconclusive Test - If the repeat testing results of any of the animals in the lot are “Inconclusive”, the NAHLN testing Laboratory's director reports the findings to the NVSL Director. In addition, the NAHLN testing laboratory's director notifies the AVIC and State Animal Health Official in the State where the sample was collected and the State where the carcass is being held pending test results. The AVIC reports results for the entire lot of samples to the submitter only after the VS Deputy Administrator's Office or District Director has given permission to release such information. The AVIC must concur with any decision to hold or dispose of the carcasses pending confirmatory testing.

d. The NAHLN testing laboratory immediately forwards all submitted materials associated with inconclusive screening test results to NVSL with prior notification and confirmation of arrival. NVSL sends all confirmatory test results directly to the VS District Office. The AVIC contacts the sample collector and the facility where the sample was collected so that carcass disposal can be coordinated and verified.

G. CNS Condemned Cattle at Slaughter – Communication and Identification

1) Communication regarding CNS Condemned Cattle by FSIS, State Meat Inspection Personnel, or Slaughter Plant Management

The AVIC coordinates with:

a. FSIS personnel, the State meat inspection agency, or the slaughter plant management:

1. To notify VS personnel and contractors whenever a bovine has been condemned for CNS signs to ensure that it is sampled in a timely manner.

2. To develop a plan for ensuring samples from CNS condemned animals over 1 (one) year of age that are rabies suspects are submitted to a rabies laboratory prior to being submitted to a BSE laboratory for BSE testing. The plan could include VS delivering the sample to the rabies laboratory or providing FSIS with shipping materials to submit the sample to the laboratory.

b. FSIS personnel at the local and district levels work with slaughter establishment management to ensure that management notifies VS contractors performing specimen collection at offsite facilities when cattle are condemned for CNS signs. The VS contractor should also be informed of the official ID devices (including the Z tag number), owner’s name and address, and the clinical history (to the extent possible) of these cattle at the time of this notification.

c. FSIS personnel at the local, circuit, or district levels develop notification procedures in case FSIS does not have adequate staff to collect samples in locations without offsite facilities or in other specific situations that require VS to collect samples. See FSIS Directive 10,400.1

d. State meat inspection directors (with the State animal health official) develop procedures for notifying VS personnel when CNS-condemned cattle from State inspected facilities require sampling.

2) Identification of CNS Condemned Cattle

The AVIC ensures that:

a. Protocols to document the identity of cattle condemned for CNS signs are in place and VS personnel and contractors receive appropriate training that enable them to follow these protocols.

b. VS personnel and contractors:

1. Implement procedures to document and maintain the identity of cattle condemned for CNS signs throughout the entire sample collection, submission, and testing process. This allows VS to verify that personnel sampled the appropriate animals for BSE. If testing should confirm an animal was infected with BSE, the animal’s ID will allow personnel to trace its origin.

2. Record the FSIS Z tag in the appropriate block of the BSE Surveillance Data Collection Form. They should also enter this information into the electronic version of this form, the VS Laboratory Submissions (VSLS) – BSE Module, by selecting “FSIS Condemnation Tag,” as the ID type and including the prefix “Z” with the tag number. Do not place a hyphen between the Z and the numbers that follow.

3. Record all other types of animal ID devices, brands, and tattoos associated with the condemned animal on the current version of the BSE Surveillance Data Collection Form and enter this information in the VSLS – BSE Module.

These additional ID devices may remain intact on the carcass or may be https://www.fsis.usda.gov/wps/wcm/connect/09bf6ed8-1e4b-4ef5-a3e1-fa454b116b8e/10400.1.pdf?MOD=AJPERES collected in a labeled bag and maintained until personnel receive test results for the animal. When appropriate, personnel may take digital pictures or drawings of brands and/or collect tissue containing the tattoo.

4. Coordinate with slaughter establishment management to develop a system to identify cattle condemned for CNS signs that have no ID devices, and to correlate the identities of these animals with the appropriate FSIS Z tag number.

5. Follow all identification protocols, either by reviewing required documentation and/or procedures at appropriate intervals or by delegating this review to appropriate VS personnel.

H. Humane Handling of Livestock

Animal handling and euthanasia procedures for all animals must comply with applicable local, State, and Federal laws, regulations, and policies. This includes local and professional standards for humane handling and euthanasia of livestock.

I. Disposal of Carcasses and Offal

1) Disposal of carcasses and offal must comply with applicable local, State, and Federal laws, regulations, and policies. Local and professional standards for disposing of or further processing animal carcasses, parts of dead animals, offal, and animal waste also apply.

2) Carcasses and offal from sampled animals intended for further processing must be held until the sample submitter receives test results from NAHLN and/or NVSL. If carcasses and offal from sampled animals are not held, the Ruminant Health Commodity staff BSE staff officers and NVSL make the decision to proceed with testing the samples on a case-by-case basis.

a. The identity of sampled carcasses and associated offal must be documented and maintained throughout the entire sample collection, submission, and testing process until “not detected” test results are obtained.

b. After obtaining “not detected” test results, carcasses and offal may be rendered or otherwise processed in accordance with applicable local, State, and Federal laws, regulations, and policies.

c. Vendors must comply with local, State, and Federal laws, regulations, and policies related to processing animals and animal byproducts for use in animal foods or feed.

3) Carcass and offal from sampled animals not intended for further processing may be disposed of before receiving test results by:

a. Burial in an approved landfill.

b. Burial on the farm of immediate origin.

c. Rendering at a dedicated facility for non-animal feed use, such as biofuel or cement.

d. Incineration.

e. Alkaline digestion.

4) Hides of sampled animals do not require disposal and do not need to be held pending test results. If the only identification on the animal is a tattoo or brand, the hide should be held, or pictures taken that clearly show the tattoo or brand.

5) NAHLN laboratories will dispose of specimens as directed by the NVSL and described in the current version of standard operating procedure SOP-PS-0051, “Protocol for Bovine Spongiform Encephalopathy (BSE) Approved National Animal Health Laboratory Network (NAHLN) Laboratories to Receive and Test Bovine Brain Samples and Report Results for BSE Surveillance.” A copy can be obtained from NVSL by calling 515-337-7514.

6) The carcasses and offal from sampled animals with inconclusive or positive test results will also be disposed of according to the guidelines in the current BSE Response Plan. If testing confirms an animal was infected with BSE, previously buried carcasses may be exhumed.

J. Cost Recovery Payments

Payments for the services listed in Appendix 3 (Cost Recovery Methods) must be made according to approved cost recovery guidelines and payment procedures. Additional payments may be approved on a case-by-case basis with appropriate justification provided to and approved by the District Office. Payments for sample collection, identification, packing, transportation, and storage and disposal of carcasses at rendering, 3D and 4D establishments, and offsite collection facilities will be made according to provisions of competitive contracts between APHIS and sample collectors.

7. Inquiries

Send any questions related to this document to VS.SP.Cattle.Health.Center@usda.gov.

Appendix 1: Designated NAHLN Laboratories for Bovine Spongiform Encephalopathy Sample Submission mailto:VS.SP.Cattle.Health.Center@usda.gov

Appendix 2: Personal Safety Appendix 3: Cost Recovery Methods

Appendix 1 – Designated NAHLN Laboratories for Bovine Spongiform Encephalopathy Sample Submission

All samples must be submitted to the designated NAHLN laboratories listed below unless otherwise directed by the National Veterinary Services Laboratories.

State where sample collected Designated Laboratory Alabama, Arizona, Colorado, Florida, Kansas, Montana, North Carolina, North Dakota, Nebraska, Utah, Wyoming

Colorado State University Veterinary Diagnostic Laboratory 300 West Drake Fort Collins, CO 80523 970-297-5000

Arkansas, Connecticut, Delaware, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Maine, Missouri, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Vermont, West Virginia

Athens Veterinary Diagnostic Laboratory 501 DW Books Drive University of Georgia Athens, GA 30602 706-542-5568

Idaho and others as requested or redirected USDA, APHIS, VS, National Veterinary Services Laboratories

(NVSL)

1920 Dayton Ave Ames, IA 50010 515-337-7526

Alaska, California, Hawaii, Iowa, Kentucky, Minnesota, New Mexico, Nevada, Oregon, South Dakota, Washington

Washington Animal Disease Diagnostic Laboratory Bustad Hall Room 155-N Pullman, WA 99164 509-335-9696

Indiana, Michigan, Mississippi, Texas, Wisconsin

Wisconsin Veterinary Diagnostic Laboratory University of Wisconsin – Madison 445 Easterday Lane Madison, WI 53706 608-262-5432

Additional contact information for the laboratories can be found online here.

https://www.aphis.usda.gov/animal_health/nahln/downloads/bse_lab_list.pdf

Appendix 2 – Personal Safety

If bovine spongiform encephalopathy is transmissible to humans in the occupational setting, the most likely routes would be through contact with infective tissues through wounds or open lesions on the skin; through contact with mucous membranes (eyes and mouth); or, in exceptional cases, by swallowing. Airborne transmission (i.e., inhaling infectious airborne particles) is the least likely route of exposure.

Because rabies, listeriosis, and other possible zoonotic diseases may be included in the differential diagnosis, brain and spinal cord from cattle with central nervous system clinical signs must be collected carefully. The following precautions generally apply:

• Adhere to safe working practices and take precautions to avoid or minimize using tools and equipment likely to cause cuts, abrasions, or puncture wounds.

• Wear suitable protective clothing, which includes disposable coveralls, aprons, heavy gloves, and boots.

• Cover existing cuts, abrasions, and skin lesions on exposed skin with waterproof dressings.

• Use face protection to protect the mucous membranes of the eye, nose, and mouth from exposure to infective droplets or tissue fragments.

• Take steps to avoid the creation of aerosols and dusts when engaged in activities such as sawing through the skull bones. For this reason, do not use forceful removal of brain/CNS through the foramen magnum using a water or air hose.

• Wash hands and exposed skin after removing or handling any tissues or materials submitted for testing.

• Wash and disinfect protective clothing and instruments thoroughly after use.

Additional guidance for Animal and Plant Health Inspection Service employees concerning personal safety is available here.

https://my.aphis.usda.gov/myportal/myaphis/employeeresources/forms-and-publications/aphis_safety_health_manual/

Appendix 3 – Cost Recovery Methods

Fee-basis payments for accredited veterinarians performing sample collection can be made in accordance with VS Directive 5019.1 and the cost recovery guidelines. Any full-service fee, other than those addressed in VS Directive 5019.1, may qualify for payment if the activity is described below.

VS may award agreements or competitive contracts to individuals, State agricultural agencies, and vendors to collect samples from targeted subpopulations at specific collection sites. The price paid per sample to the contractor includes services and materials such as all personnel, labor, supervision, supplies, and equipment. The price paid also includes all costs associated with identification, transport, storage, and disposal of carcasses in accordance with applicable Federal, State, local, and contract requirements.

Compensation will only be provided for samples collected from animals in the targeted subpopulation and for those that have a valid test result posted in the Veterinary Services Laboratory Submission System. "Not detected/not obex" or "not tested" are not considered valid test results in the Bovine Spongiform Encephalopathy (BSE) Ongoing Surveillance Program, and submitters will not be paid for these samples unless noted otherwise.

Cost Recovery Fee Guidelines Activity Fees Paid

Identification and Storage – Includes identification and storage of carcasses and products

Up to $100/sample

Transportation of animals, carcasses, or heads for BSE sampling

Up to $2/loaded mile

Sample collection* – Includes removal of head and collection of obex

Up to $40/sample

Head removal* – Includes head removal and presentation to authorized collectors

Up to $10/head

Complete sample collection/submission by accredited veterinarian – Includes travel, collection of the brain stem, data processing, and submission of samples

Up to $100/sample

Disposal of carcasses Up to $100/carcass (for on-farm burial, composting, or in an approved landfill)

Up to $500/carcass (for incineration)

*Either sample collection or head removal may be paid, but not both.

In addition to the above cost recovery fees, APHIS will purchase any product derived from a BSE-infected animal (as confirmed at the National Veterinary Services Laboratories) that cannot be sold because of an action or request by the Food and Drug Administration. APHIS will pay the fair market value for the product plus disposal costs. These costs will be covered only when the facility’s actions accord with APHIS policies and procedures. APHIS will determine actual cost after reviewing documentation and invoices for the disposition of the product.

If the actual costs are expected to exceed the cost recovery fee guidelines, the District Office must approve before costs are incurred. The request for exceeding the cost recovery fee guidelines includes a justification with anticipated costs, actions to preclude recurrence, if possible, and evidence that no other reasonable alternatives exist. The District Director determines whether to authorize the sample submission based on the justification and the expected value of the samples to the BSE Ongoing Surveillance Program. If the District Director approves the authorized amount, the District Office will keep a record of the approval.