5C-18.003. Official Test

(1) Official Test. The Department will only accept the results of an EIA test to be negative or positive if the EIA test is an Official Test that:

(a) Is conducted in an Approved Laboratory;

(b) Utilizes a diagnostic product that is licensed by USDA, APHIS, as provided in the Equine Infestious Animia: Uniform Methods and Rules, January 10, 2007, APHIS 91-55-064 incorporated in paragraph 5C-3.003(3)(a), F.A.C.;

(c) Is collected and submitted by an Accredited Veterinarian or Department Representative;

(d) Is submitted with and reported on:

1. An Equine Infestious Anemia Test Form, VS Form 10-11 (Dec 2020), as incorporated in subsection 5C-18.010(10), F.A.C., with all sections and copies, must be complete, legible, and accurate with a detailed description of the horse that the test record represents including the following information:

a. The breed registration number or registry tattoo, when applicable;

b. The name of the Equine;

c. The physical address of where the Equine permanently resides at the time of the EIA test sample was taken;

d. The age, breed, sex and color; and

e. All other distinctive markings, including markings on the legs and face, color patterns, body brands, tattoos, scars, whorls, blemishes, and microchip information if available.

2. Other reporting forms approved by another state’s animal health officials and the USDA; or

3. An Electronic EIA Laboratory Test as defined in subsection 5C-18.001(10), F.A.C.

(2) Rejected Test Report. A report of an EIA test will be rejected if the report:

(a) Appears to be forged, counterfeited, simulated, or altered;

(b) Does not have all information completed, including sufficient identification of the Equine; or

(c) Is an Equine Infestious Anemia Test Form, VS Form 10-11 (Dec 2020), as incorporated in subsection 5C-18.001(10), F.A.C., and is not an original owner’s copy or a laboratory certified copy; except that for purpose other than change of ownership within Florida, a clear and legible photocopy of the owner’s original copy is acceptable; or

(d) Is an Electronic EIA Laboratory Test and does not contain three clear, color digital images as required.

(3) Approved Laboratory Requirements:

(a) Permit Required. Any laboratory which conducts a test for EIA within Florida must:

1. Be issued a Permit for Approved Laboratory for Equine Infectious Anemia Testing, FDACS-09084 Rev. 06/20, issued by the Department. Permit for Approval Laboratory for Equine Infectious Anemia Testing, FDACS-09084 Rev. 06/20 is hereby incorporated by reference and available online at http://www.flrules.org/Gateway/reference.asp?No=Ref-13434.

2. Complete and submit a Permit Requirements For Private Laboratory to Conduct Equine Infectious Anemia (EIA) Tests, FDACS-09265 Rev. 06/21, issued by the Department. Permit Requirements For Private Laboratory to Conduct Equine Infectious Anemia (EIA) Tests, FDACS-09265. Rev. 06/21 is hereby incorporated by reference and available online at http://www.flrules.org/Gateway/reference.asp?No=Ref-13435.

(b) Application for Permit.

1. Written Request. A written request for a permit to conduct EIA test(s) must be submitted to the Florida Department of Agriculture and Consumer Services, Division of Animal Industry, 407 South Calhoun Street, Tallahassee, Florida 32399-0800.

2. Application Fee. An application fee of $50.00 must be submitted with each written request. The fee must be submitted as a check or money order made payable to the Florida Department of Agriculture and Consumer Services. This fee is waived for the Department’s Bureau of Diagnostic Laboratory.

(c) Requirements for Permit. The Department will issue a Permit for Approved Laboratory for Equine Infectious Anemia Testing, FDACS-09084, Rev. 06/20 upon a laboratory’s submission of a complete application and application fee as provided in paragraph (b), and compliance with the following requirements:

1. Laboratory Inspection and USDA Approval. A USDA, APHIS representative must inspect the laboratory and determine that the laboratory is in compliance with and has the facilities and equipment which are specified in USDA Veterinary Services Memorandum 15201.1 (Apr. 5 2019), and 9 C.F.R. §75.4(c) (2018). USDA Veterinary Services Memorandum 15201.1 (Apr. 5 2019) is hereby incorporated by reference and available online at http://www.flrules.org/Gateway/reference.asp?No=Ref-13432. 9 C.F.R. §75.4(c) (2018) is hereby incorporated by reference and available online at http://www.flrules.org/Gateway/reference.asp?No=Ref-13431.

2. Certification to Comply. The applicant for the permit must certify that the laboratory will comply with all provisions of this rule by signing the Agreement to Conduct the Equine Infectious Anemia Agar Gel Immuno-Diffusion Testing & Statement of Certification, FDACS-09130 Rev. 06/21. Agreement to Conduct the Equine Infectious Anemia Agar Gel Immuno-Diffusion Testing & Statement of Certification, FDACS-09130 Rev. 06/21 is hereby incorporated by reference and available online at http://www.flrules.org/Gateway/reference.asp?No=Ref-13436.

3. Test Check Proficiency Results. The laboratory will certify to the Department that it will forward a copy of all test check proficiency results performed in accordance with 9 C.F.R. §75.4(c) (2018) upon request after they are received by the laboratory. 9 C.F.R. §75.4(c) (2018) as incorporated in subparagraph 5C-18.003(3)(c)1., F.A.C.

(d) Renewal of Permits.

1. All issued Permits for Approved Laboratory Equine Infectious Anemia Testing, FDACS-09084, Rev. 06/20, expire on December 31 of each year.

2. The Authorized Laboratory Representative must submit the following prior to November 30 of each year for renewal of a laboratory’s Permit for Approved Laboratory for Equine Infectious Anemia Testing, FDACS-09084, Rev. 06/20:

a. Certification of continuous compliance with the requirements in 9 C.F.R. §75.4 (2018) as incorporated in subparagraph 5C-18.003(3)(c)1., F.A.C., Veterinary Services Memorandum 15201.1 (Apr. 5 2019) as incorporated in subparagraph 5C-18.003(3)(c)1., F.A.C., and all requirements of Chapter 5C-18, F.A.C., by completing the form, Agreement to Conduct the Equine Infectious Anemia Agar Gel Immuno-Difffusion Testing & Statement Certification, FDACS-09130 Rev. 06/20 as incorporated in subparagraph 5C-18.003(3)(c)2., F.A.C.;

b. Copies of reports of all inspections of the laboratory facilities conducted during the current certification period; and

c. Copies of test sample proficiency results consistent with the requirements of this rule.

(e) Revocation of Permit. The Department will revoke any issued Permit for Approved Laboratory for Equine Infectious Anemia Testing, FDACS-09084, Rev. 06/20 for the following reasons:

1. The laboratory does not immediately report a non-negative EIA test to the Department, as required in paragraph 5C-18.004(2)(b), F.A.C.;

2. The laboratory falsifies a record or a report of an EIA test; or

3. The laboratory no longer meets the standards and requirements as specified in 9 C.F.R. §75.4(c) (2018), USDA Veterinary Services Memorandum 15201.1 (Apr. 5 2019). 9 C.F.R. §75.4(c) (2018) is incorporated in subparagraph 5C-18.003(3)(c)1., F.A.C., and USDA Veterinary Services Memorandum 555.16 (2011) is incorporated in subparagraph 5C-18.003(3)(c)1., F.A.C.

(4) Procedures for Identifying EIA Test Samples.

(a) Receiving Samples. The laboratory must confirm that all EIA test samples received are accompanied by Equine Infectious Anemia Test Form, VS Forms 10-11 (Dec 2020) or an Electronic EIA Laboratory Test, which meet the following requirements:

1. All Equine Infectious Anemia Test Form, VS Forms 10-11 (Dec 2020) and Electronic EIA Laboratory Tests are reviewed by the laboratory staff to ensure that they are complete and accurate.

2. Information needed on incomplete Equine Infectious Anemia Test Form, VS Forms 10-11 (Dec 2020) or an Electronic EIA Laboratory Test must be obtained from the submitting Accredited Veterinarian before the samples may be tested; and

3. The laboratory must confirm that the veterinarian who signed the Equine Infectious Anemia Test Form, VS Forms 10-11 (Dec 2020) or Equine Infectious Anemia Laboratory Test, is accredited pursuant to the USDA, APHIS National Veterinary Accredidation Program as a category II veterinarian in the state where the blood sample was taken.

(b) Laboratory Identification of Samples. All samples must be identified by the receiving laboratory by a unique accession number with the format of YY-X00000, where:

1. YY corresponds to the last two digits of the current year;

2. X is a unique letter assigned by the Department to the laboratory for identification of the laboratory; and

3. 00000 represents consecutive numbers for tests conducted by that laboratory, beginning with 00001 on January 1 of each year.

(5) Laboratory Records, Record Keeping.

(a) The laboratory must maintain a daily log, which records the following test sample information:

1. Date of receipt of test sample;

2. The assigned accession number;

3. Name of the Accredited Veterinarian who submitted the sample;

4. Name of the owner of the Equine;

5. The specific test used;

6. The test result;

7. The date that the report of the EIA test was provided to the submitting veterinarian; and

8. For all non-negative tests, the name of the contact person in the Department and the date that the report of the non-negative EIA test was made to him/her.

(b) Daily logs for the current year and three preceding years must be available for immediate reference or inspection by a Department Representative or USDA, APHIS representative.

Rulemaking Authority 585.002(4), (5), 585.08(2), 585.671 FS. Law Implemented 585.002(5), 585.671, 585.11(1) FS. History–New 10-15-73, Formerly 5C-18.03, Amended 8-15-94, 8-3-99, 9-12-21.