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Description/Specifications/Work Statement for Regulatory Scrapie Slaughter Surveillance (RSSS) Collection Sites Animal and Plant Health Inspection Service (APHIS) Veterinary Services (VS) Option 4: Collection, Submission, and Shipment of Obex and/or Lymph Node Samples Background The United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS) is continuing national surveillance activities for scrapie in sheep and goats, the Regulatory Scrapie Slaughter Surveillance (RSSS) program. The intent is to collect and analyze samples from all sheep and goats meeting targeted criteria. Scope of Work The scope of this project involves on-site collection, identification, packaging, storage, shipping of samples, and data entry into an electronic submission system by the Vendor. Samples should only be obtained from mature sheep or goats that meet targeted criteria (detailed below) or as directed by your APHIS VS contact. Mature is defined as having complete eruption of at least one permanent incisor (first permanent incisor is level with or extends above the remaining deciduous teeth). Vendor’s Performance Objectives The Vendor shall provide all personnel, labor, supervision, supplies, equipment, and materials required for collection and processing of whole heads on-site, with the exception of RSSS sampling kits provided by APHIS VS. Steps involved in processing include collection and preservation of samples as described below, identification of the samples, data entry into the Veterinary Services Laboratory Submission (VSLS) web- based program, and shipping of samples to a designated laboratory. The Vendor, in accordance with 9 CFR 79, shall provide information and/or access to consignment records in the event that a scrapie-positive animal is identified and an epidemiological investigation is initiated as a result of the contracted surveillance activities. The Vendor is responsible for all transport, storage, and disposal of carcasses/carcass parts or other waste remaining after sampling in accordance with all applicable federal, state, local and contract requirements. July 2021 Page 1 Sample Selection Samples should only be obtained from mature animals, as evidenced by complete eruption of at least one permanent incisor (first permanent incisor is level with or extends above the remaining deciduous teeth). The Vendor shall collect and submit suitable whole heads from all mature sheep and/or goats that meet the following criteria: 1. Any sheep (regardless of face color) or goat that is from 18 months of age up to 72 months of age (i.e. under 7 yrs.) as evidenced by examination of the teeth. A sheep or goat will be considered 18 month or over if the second permanent incisor is erupted and over 72 months of age if the 4th permanent incisor is fully erupted and there are broken, missing, blunt, elongated, splayed teeth, or other significant signs of dental wear present. (As a guide, of those heads determined to be over 4 years of age, less than 30 percent should be 5 years of age.) 2. Any mature sheep or goat that exhibits any of the following clinical signs: A. Dead prior to slaughter or condemned on ante-mortem inspection. B. Nonambulatory a. Down and unable to rise; or b. Able to rise but only for brief periods of time. i. Nonambulatory animals can include those with broken appendages, severed tendons or ligaments, nerve paralysis, fractured vertebral columns, or metabolic conditions. C. Signs of central nervous system (CNS) disease including: a. Weakness of any kind, including stumbling, falling down, or having difficulty rising, not including those with visible traumatic injuries which should be recorded as nonambulatory animals; or b. Behavioral abnormalities; or c. Increased sensitivity to noise and sudden movement; or d. Tremors; or e. Star gazing; or f. Head pressing; or g. Bilateral gait abnormalities, including incoordination, high stepping gait of forelimbs, bunny-hop movement of rear legs, or swaying of back end, but not including abnormalities involving only one leg or one front and one back leg; or h. Other CNS signs. D. Intense rubbing, abrasions, or rough, thickened, and/or hyperpigmented skin: a. Repeated intense rubbing with bare areas in similar locations on both sides of the animal’s body or, if on the head, both sides of the poll; or b. Abraded, rough, thickened, or hyperpigmented areas of skin in areas of wool/hair loss in similar locations on both sides of the animal’s body or, if on the head, both sides of the poll. E. Condemned post-mortem for emaciation. July 2021 Page 2 3. Any mature sheep or goats: A. with an SFCP tag (up to 30 animals cumulative per flock or herd, i.e. not on the “Do Not Collect” list); or B. that are received on a VS 1-27 permit (e.g. scrapie-exposed animals that are not in source or infected flocks, identified by yellow “exposed” eartag); or 4. Any sheep or goats when directed in writing by the APHIS contact. Sheep and goats from herds on the current “Do Not Collect” list should only be sampled if they are exhibiting clinical signs, they arrived on a VS 1-27 permit, or when directed in writing by the APHIS contact. VS may periodically revise the sampling criteria in agreements during their term by giving the establishment at least 30 days written notice without having to revise and re- sign the agreement. Note: VS plans to implement a points-based sampling criteria in the future that may affect the above selection criteria. Refer to the attached RSSS Targeted Criteria Flowchart Collection Method The Vendor collects and submits tissues: The Vendor collects and ships specific tissues from mature sheep and/or goats that meet targeting criteria, including a small portion of the ear with the eartag attached. The tissues collected include the obex, cerebellum, and retropharyngeal lymph node (RLN). A quarter-sized portion of the ear must be attached to the eartag. If necessary, this tissue will be used to confirm genotype of the animal. In addition to sample collection and shipment, the Vendor will be required to enter submission information into an electronic submission system (VSLS). VS personnel will provide training to the Vendor on proper collection, preservation, packaging, shipping of samples and data entry into VSLS. Tissue collection, storage and shipping instructions are also detailed in “Procedure Manual: Regulatory Scrapie Slaughter Surveillance (RSSS) Tissue Collection and Submission”. Vendors are responsible for the quality of samples that are submitted to the designated laboratory or processing site. In order to receive payment, the submitted samples (1) must have been collected from sheep and/or goats that meet the targeted criteria AND (2) arrive at the APHIS designated laboratory or processing site in suitable condition for scrapie testing AND (3) be shipped to the designated laboratory or processing site within one week from collection AND (4) be properly packaged to prevent breakage or leakage. It is permissible to batch samples from July 2021 Page 3 different slaughter dates into one shipment, but each sampling date requires individual submission entries into VSLS Carcasses should NOT be retained pending the results of scrapie testing conducted through this program. Fee Schedule The Vendor will be paid $_____for the first suitable RLN sample in a shipment and $_____ for each additional suitable RLN sample in the shipment. If both the RLN and the obex are submitted, the Vendor will be paid $_____ for the first suitable sample in a shipment and $_____ for each additional suitable sample in the shipment. Total fiscal year costs under this agreement will not exceed ______. Cost overruns will be the sole responsibility of the Vendor. Estimated Volume Expected number of days per week/ month/ year (circle the most appropriate) on which mature sheep or goats will be slaughtered _____. On average ________ targeted animals will be slaughtered per day at the facility on those days when mature sheep or goats are slaughtered. The minimum and maximum number of targeted samples that the facility expects to collect during a 12 month period. Min_____________ Max_____________ Documentation/Reporting Requirements In addition to sample collection and shipment, the Vendor must enter information for all RSSS submissions into VSLS. Information required includes: name of collection site, name of collector/submitter, surveillance information (number of sheep/goats slaughtered, number with official identification, number sampled), and individual animal information (species, age, sex, face-color/type, designation, clinical signs if present, and ALL identification devices). On-site it may be useful to record all relevant information on hardcopies of the RSSS Collection Worksheet (available in VSLS under the “Blank Worksheets” tab), with subsequent data entry of the worksheet into VSLS. If used, the original completed worksheet(s) should be filed on-site. Training for data entry into the VSLS application will be provided by VS personnel. Immediately communicate with the provided point-of-contact any issues that would prevent timely submission or shipment of collected tissues. July 2021 Page 4
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