Permanent Final Adoptions

TITLE 35. Oklahoma Department of Agriculture, Food, and Forestry

CHAPTER 15. Animal Industry

[OAR Docket #10-656]

RULEMAKING ACTION:

PERMANENT final adoption

RULES:

Subchapter 15. Equine Infectious Anemia (EIA)

Part 3. Procedures

35:15-15-32 through 35:15-15-34 [AMENDED]

35:15-15-36 [AMENDED]

35:15-15-37 [AMENDED]

35:15-15-39 through 35:15-15-42 [AMENDED]

AUTHORITY:

State Board of Agriculture; 2 O.S. ยงยง 2-4 and 6-281 et seq.; Article 6, Section 31, Constitution of the State of Oklahoma

DATES:

Comment period:

October 15, 2009 through November 16, 2009

Public hearing:

November 16, 2009 and February 4, 2010

Adoption:

February 17, 2010

Submitted to Governor:

February 19, 2010

Submitted to House:

February 19, 2010

Submitted to Senate:

February 19, 2010

Gubernatorial approval:

March 5, 2010

Legislative approval:

Failure of the Legislature to disapprove the rules resulted in approval on April 15, 2010

Final adoption:

April 15, 2010

Effective:

July 1, 2010

SUPERSEDED EMERGENCY ACTIONS:

N/A

INCORPORATIONS BY REFERENCE:

N/A

ANALYSIS:

The purpose of the proposed rules is to develop a licensing process for new laboratories that provide equine infectious anemia testing. Recently, USDA lifted the ban on licensing of new equine infectious anemia laboratories. The rule establishes criteria for licensing and provides a licensing fee for these facilities. In addition, the proposed rules clean up the procedural rules for equine infectious anemia.

CONTACT PERSON:

Teena Gunter, Oklahoma Department of Agriculture, Food, and Forestry (405) 522-4576

PURSUANT TO THE ACTIONS DESCRIBED HEREIN, THE FOLLOWING RULES ARE CONSIDERED FINALLY ADOPTED AS SET FORTH IN 75 O.S. SECTION 308.1(A), WITH AN EFFECTIVE DATE OF JULY 1, 2010:

SUBCHAPTER 15. Equine Infectious Anemia (Eia)

PART 3. PROCEDURES

35:15-15-32. Personnel authorized to collect blood samples

All official samples collected from Equidae for EIA testing shall be collected by a state or federal veterinarian or by, an accredited veterinarian, or an authorized agent of the Board.

35:15-15-33. Submission of sample and test charts

(a) All blood samples submitted for official tests shall be accompanied by a properly completed VS Form 10-11 Equine Infectious Anemia Laboratory Test listing the following:

(1) Description of the Equidae, including the age, breed, color, sex, animal's name, any registration number, all distinctive markings, including color patterns, brands, tattoos, scars, or blemishes. In the absence of any distinctive color markings or visible permanent identifications, the Equidae shall be identified by indicating the location of all hair whorls, vortices, or cowlicks with an "X" on the illustration provided on the VS Form 10-11.

(2) Owner's name, address, and telephone number.

(3) The animal's home premise and county.

(4) The name, address, and telephone number of the authorized person collecting the test sample.

(5) The laboratory and the person conducting the test.

(b) All blood samples taken from the animal listed on the VS Form 10-11 shall be submitted in approved tubes and the tubes shall be identified with the same animal name, registration number, tattoo, or other identification as recorded on the VS Form 10-11.

(c) Samples submitted without proper identification and proper test charts shall not be classified.

(d) Authorized personnel shall use only one chart or VS Form 10-11 for each Equidae to be tested.

35:15-15-34. Requirements for approved EIA testing laboratories

(a) No person shall operate an EIA testing laboratory without first obtaining approval from the Board.

(b) Conditions of approval.

(1) Submit a complete application to the office of the State Veterinarian.

(2) Upon receipt of an application, the facility shall be inspected by an authorized agent of the Board.

(3) A report of the inspection shall be submitted to the State Veterinarian and identify the EIA testing laboratory's compliance with the minimum standards for facilities, equipment, and personnel.

(4) The applicant shall agree in writing to operate the laboratory in conformity with the Department rules and the requirements of the USDA and shall continually meet all requirements during operation of the laboratory.

(5) A determination by the Department that an additional EIA laboratory is necessary in the area.

(c) Operating requirements.

(1) All personnel conducting an official test at an approved laboratory shall receive training prescribed by the National Veterinary Services Laboratories (NVSL).

(2) Approved laboratories shall use USDA licensed antigen and follow standard test protocols prescribed by NVSL.

(3) Approved laboratories shall maintain a work log clearly identifying each individual sample and test results.

(4) Approved laboratories shall maintain a work log and a file of all submission forms for a period of not less than two (2) years.

(5) All approved laboratories shall report all positive results to an official test for EIA to the State Veterinarian's office within twenty four (24) hours.

(6) A copy of all test charts for positive Equidae shall be sent to the State Veterinarian's office within seventy two (72) hours.

(7) Negative results shall be reported to the office of the State Veterinarian on a monthly basis.

(d) Inspections and, proficiency tests, and licenses.

(1) The Board shall randomly and without prior notification collect samples and inspect the facilities and records of all EIA laboratories in Oklahoma at a minimum of once per year.

(2) All records required to be maintained by approved laboratories shall be open to inspection by state or federal employees during normal business hours.

(3) All approved laboratories shall pass annual proficiency test requirements administered by the NVSL.

(4) All approved laboratories shall pass any additional proficiency test requirements administered by the Board.

(A) All approved laboratories that pass the additional proficiency test requirements administered by the Board shall be published on the Department maintained list of "Oklahoma Certified EIA Laboratories."

(B) The Board shall charge a fee to the approved laboratory for administering each additional proficiency test in the amount of Fifty Dollars ($50.00).

(C) The Board may waive any additional proficiency test requirements if an approved laboratory enters into a written agreement with the State Veterinarian and is designated as "ELISA Only" on the Department maintained list of "Oklahoma Certified EIA Laboratories."

(5) The Board shall charge a fee to the approved laboratory for administering each additional proficiency test in the amount of Fifty Dollars ($50.00).

(6) Each approved laboratory shall obtain a license on an annual basis.

(A) The annual license fee shall be $250.00.

(B) The annual license shall expire on January 31 of each calendar year.

(C) The renewal license application shall be submitted no later than January 31 of each calendar year.

(D) A renewal application received or postmarked after January 31 shall be in violation of these rules.

(E) Failure to renew may result in disapproval of the laboratory.

(F) A fee waiver may be granted to an EIA laboratory at a university or state agency.

(e) An EIA laboratory may have its approval cancelled if the Board finds that the laboratory has failed to meet the requirements or has falsified records or reports.

(f) Any action taken by the Board to cancel laboratory approval shall conform to the Administrative Procedures Act.

(g) The Department may deny the application of any EIA laboratory if it fails to meet any criteria required by the Department.

(h) State approvedApproved laboratories shall only perform the EIA-ELISA test.

(i) The Department may at its discretion in limited and approved circumstances grant state approved laboratories the ability to perform the AGID test for equine being exported from Oklahoma to a foreign country or for horses not residing in Oklahoma. The limited exception shall be detailed in a written agreement between the Department and the state approved laboratory.

(j) Any approved EIA laboratory shall resubmit all application information for approval by the Department upon a change in ownership of the facility or a change in location of the facility.

35:15-15-36. Classification of Equidae tested

(a) All Equidae tested for EIA pursuant to an official test shall be classified as negative or positive.

(b) Positive Equidae and retests.

(1) A positive is any Equidae which discloses a positive reaction to an official test.

(2) Equidae classified as positive may be retested prior to branding upon the owner's written request to the State Veterinarian no more than fifteen (15) days following the date of the original test.

(3) All retest samples shall be collected by a state or federal veterinarian, an accredited veterinarian, or an authorized agent of the Board and submitted to the Oklahoma Department of Agriculture, Food, and Forestry Laboratory Services.

(4) The owner shall provide documentation to the state or federal veterinarian collecting the retest sample verifying the equine tested is the same animal identified as positive on the original test document.

(5) All positive Equidae shall be held in isolation and under quarantine until the retest results are received.

(6) All other Equidae on the premise shall be held under quarantine until the retest results are received.

(7) Retest results from the Oklahoma Department of Agriculture, Food, and Forestry Laboratory Services shall be the official retest results. Results from other approved laboratories shall not be official when conducted as retests of positive animals.

(c) All Equidae that show a negative response to an official test shall be classified negative by the approved laboratory.

(d) The designated epidemiologist may deviate from the positive or negative classification so long as the reasons to do so are documented.

35:15-15-37. Reporting of test results

(a) The person operating an approved laboratory shall notify the State Veterinarian's office and the individual submitting the sample for testing within twenty four (24) hours of all positive test results.

(b) The individual who collected the test sample shall notify the owner of the positive horse within forty eight (48) hours of all positive test results and of the quarantine resulting from the positive test results.

(c) Approved laboratories shall only report test results on samples properly submitted and accompanied by a completed VS Form 10-11.

(d) An Any person operating an approved laboratory that reports results prior to the appropriate time period necessary for the proper completion of an official test shall be in violation of these rules and may be subject to removal of the laboratory's approved status and other administrative remedies.

35:15-15-39. Quarantines

(a) Any Equidae testing positive to an official test shall be quarantined to the premise of origin or other approved premise until natural death, disposition by euthanasia or slaughter, or movement to a quarantined holding facility.

(b) The quarantine shall include the positive Equidae, all other Equidae on the premise, and all Equidae epidemiologically determined to have been exposed to an EIA positive animal.

(c) The owner shall maintain isolation of all Equidae on an affected premise a minimum of two hundred (200) yards from all other negative Equidae and Equidae of unknown status on adjacent premises.

(d) In addition to a quarantine, the owner may enter into a herd plan for an affected herd.

(e) The owner of an adjacent or exposed herd may enter into a herd plan in addition to a quarantine or in lieu of a quarantine, pursuant to an agreement with the State Veterinarian.

(f) The issuance of a quarantine may be waived if the Board or the State Veterinarian enters into a formal memorandum of understanding with the owner that controls the movement of animals and the disease condition.

(g) Release of quarantine.

(1) No Equidae held under quarantine shall be moved or released until a written permit or quarantine release signed by an authorized agent has been executed.

(2) The EIA quarantine may be released by an authorized agent after all quarantined Equidae in the affected herd test negative to an official test conducted at the Oklahoma Department of Agriculture, Food, and Forestry no less than sixty (60) days nor more than one hundred twenty (120) days following the identification and removal of the last EIA positive animal.

(3) Epidemiologic data may be considered in the release of the quarantine.

35:15-15-40. Testing requirements in affected herds

(a) All test eligible Equidae determined to have been on the same premise as an EIA positive animal at the time the positive animal was tested shall be tested by a state or federal veterinarian or an authorized agent of the Board within thirty (30) days of the confirmation of the positive EIA test.

(b) A second test shall be conducted not less than sixty (60) days nor more than one hundred twenty (120) days following removal of the last positive Equidae for quarantine release.

(c) Foals nursing EIA positive mares shall be tested not less than sixty (60) days nor more than one hundred twenty (120) days upon weaning and isolation from any positive animal. If positive, foals may remain under quarantine for additional testing at the discretion of the designated epidemiologist.

35:15-15-41. Testing in exposed, contact, and adjacent herds

(a) All test eligible Equidae epidemiologically determined to have been exposed to an EIA positive animal shall be quarantined and tested by a state or federal veterinarian, an accredited veterinarian, or an authorized agent of the Board.

(b) All test eligible exposed, contact, or adjacent herds shall be tested within thirty (30) days of notification.

(c) A second test shall be conducted not less than sixty (60) days nor more than one hundred twenty (120) days following the removal of the last positive animal from the affected herd.

(d) Exposed, contact, or adjacent herds tested by a state or federal veterinariansveterinarian or an authorized agent of the Board shall be tested at state expense so long as funds are available.

(e) Exposed, contact, or adjacent herds tested by accredited veterinarians shall be tested at the owner's expense.

(f) Epidemiologic data may be considered in the testing requirements and release of quarantine for exposed, contact, and adjacent herds.

(g) Any owner who chooses to maintain an EIA positive animal shall adhere to the following requirements:

(1) Brand and isolate the EIA positive animal in accordance with the provisions of this subchapter;

(2) Test each Equidae under common ownership or present on the property annually at the owner's expense;

(3) Submit an annual inventory of all Equidae under common ownership or present on the property to the Department by June 30 of each year; and

(4) Test any Equidae thirty (30) days prior to any sale or movement of any Equidae under common ownership or present on the property.

35:15-15-42. Movement of positive and exposed animals

(a) All positive and exposed Equidae shall be accompanied by a permit when moved from any quarantined premise.

(b) All movement of positive or exposed Equidae shall be direct to an approved slaughter facility, to a quarantined holding facility prior to movement to an approved slaughter facility, or to a research facility approved by the State Veterinarian.

(c) Any An owner who intends to change in the location of positive or exposed Equidae to an alternate quarantined premise shall be approved request approval at least thirty (30) days in advance and shall only move the animal following an epidemiological investigation by a state or federal veterinarian.

(d) No diversion from the destination identified on the permit is allowed.

(e) If a change in destination is necessary, a new permit shall be issued.

[OAR Docket #10-656; filed 4-21-10]