Section 85.135  Requirements for Establishing and Maintaining a Herd Under the Voluntary Paratuberculosis (Johne's Disease) Certification Program

a)         The following definitions shall be applicable to this Section:

1)         "Accredited laboratory" means a laboratory operated by the Illinois Department of Agriculture, the University of Illinois College of Veterinary Medicine, or a laboratory approved by the Director (on the basis of its using USDA approved methods).

2)         "Animal" means cattle, bison, buffalo, goats, llamas, or members of the cervid family.

3)         "Cow-side", "pen-side" or "on-site" test means any test approved by the USDA for M. avium paratuberculosis that can be performed in the field by an accredited veterinarian.  Veterinarians must receive approval from the Department to use this test, and all results must be reported to the Department within 10 days.  The test cannot be performed in a herd participating in the Voluntary Johne's Disease Certification Program.

4)         "Herd" means all animals under common ownership or supervision that are grouped on one or more parts of any single premises (lot, farm, ranch), or all animals on two or more premises geographically separated, but on which animals have been interchanged or where there has been contact between the premises.  Contact of animals between separated premises under common management shall be assumed to have occurred unless otherwise established by the herd owner or manager.  Each separate species of animal shall be considered as a separate herd.

5)         "Positive animal" means an animal infected with Mycobacterium avium paratuberculosis, only if M. avium paratuberculosis is demonstrated by an organism detection test on tissues or feces of the animal.

6)         "M. avium paratuberculosis-detection test" or "organism detection test" means any test sufficiently sensitive and specific for detection of M. avium paratuberculosis in fecal samples.  Definitions of "sufficiently sensitive and specific" will be on the basis of results of performance of a check test and proficiency standards set by the Uniform Program Standards for the Voluntary Bovine Johne's Disease Control Program  (June 1, 2006).  Any test approved by the USDA for M. avium paratuberculosis organism detection (i.e., fecal culture or PCR (polymerase chain reaction) test for M. avium paratuberculosis) is acceptable as long as it is performed at an accredited laboratory.

7)         "Serum antibody test" means any test sufficiently sensitive and specific for detection of antibodies to M. avium paratuberculosis in bovine serum. Definition of "sufficiently sensitive and specific" will be on the basis of results of performance of a check test and proficiency standards set by the Uniform Program Standards for the Voluntary Bovine Johne's Disease Control Program (June 1, 2006), as recommended and approved by the U.S. Animal Health Association (P.O. Box K227, Suite 114, 1610 Forest Avenue, Richmond, Virginia 23228).  Any test approved by the USDA for serum antibody detection (i.e., ELISA for M. avium paratuberculosis) is acceptable as long as it is performed at an accredited laboratory.

b)         Criteria for herds qualified to enter into the certification program:

1)         Participation in this program is voluntary and the producer/owner is responsible for the cost of testing.

2)         The herd has been in existence for at least one year or the herd was assembled with animals originating directly from paratuberculosis-certified herds only.

3)         A herd assembled with animals originating directly from certified herds only shall start at the lowest certification level of the herds from which the assembled animals were acquired.  A negative first-herd test will qualify the newly-assembled herd for the first certification level.

4)         All animals must have an approved, permanent, unique, legible identification other than a plastic ear tag or neck chain.  Acceptable types of approved, permanent, unique, legible identification include registration or association numbers accompanied by identification document, breed registry ear tattoos, USDA uniform series ear tag (metal tags), freeze branding when the brand is listed on the breed registration certificate and electronic identification (microchips) as long as a reader is supplied by the owner or is readily available.

c)         Voluntary Johne's disease herd status for cattle shall be established and maintained in accordance with the Uniform Program Standards for the Voluntary Bovine Johne's Disease Control Program (June 1, 2006) that was approved and adopted by the U.S. Animal Health Association (P.O. Box K227, Suite 114, 1610 Forest Avenue, Richmond, Virginia  23228), with the exceptions listed in subsection (c)(1).

1)         Exceptions

A)        The organism detection test will be accepted for testing at any level;

B)        Test eligible animals are all animals 24 months of age and older; and

C)        The testing strategy using environmental sampling is not allowed. Only animal testing is recognized for herd certification or herd testing for the Risk Management program.

2)         Herd owners using either the Fast Track or the Standard Track certification program must sign a herd agreement prior to acceptance into the program.

d)         Criteria for certifying bison, buffalo, goats, llamas or members of the cervid family herds under the Illinois Voluntary Johne's Disease Herd Certification Program.

1)         The following certification levels will be awarded compliance with certification requirements:

Level 1 − herd tested negative after one sampling.

Level 2 − herd tested negative after two samplings.

Level 3 − herd tested negative after three samplings.

Level 4 − herd tested negative after four samplings.

Level 5 − herd tested negative after five samplings.

Level 5 Monitored − herd tested negative after six or more samplings.

2)         Certification requirements:

A)        For annual certification, all animals 24 months of age and older must be tested.

B)        Certified herds must be tested every 12 months (+/- 2 months).

C)        All tests must be performed at an accredited laboratory.

D)        An organism detection test for M. avium paratuberculosis (i.e., fecal culture or PCR) must be conducted.

E)        Fecal collection must be done either by, or under the direct supervision of, an accredited veterinarian who must verify that the samples were collected from the animals identified on the test documents.

F)         The owner must certify on an agreement form prescribed by the Department:

i)          At the initial test date, the herd has been in existence for at least one year or was assembled only from herds enrolled in a M. avium paratuberculosis program and are at the same or higher level than the herd.  Animals purchased from herds participating in M. avium paratuberculosis programs outside of Illinois must have that state's program approved by the Director prior to certification.

ii)         At each test date, all animals in the herd 24 months of age or older were sampled and included in the herd test. A herd can qualify for certification through a split herd testing program.  The producer must test all test-eligible animals at least once a year throughout a 12 month period.  The anniversary date would be the date that the herd test is completed for the year.  The testing schedule for the year must be described in the annual herd agreement.

iii)        At each test date, a list identifying all animals previously tested but no longer in the herd  must be provided to the Department.

iv)        At each test date, all animals added to the herd since the last herd  test were natural additions to (born into) the herd, purchased from participating herds, or were tested at the time of arrival on the premises (see subsection (d)(6)).

v)         At each test date, with a written statement sent to the Department certifying to the best of his/her knowledge no animal that left the herd tested positive for paratuberculosis or was exhibiting clinical signs of Johne's disease.

3)         Upon completion of the required testing and review by the Director, the Department shall issue a certificate verifying the herd's status.

4)         Handling of animals exhibiting clinical signs:

A)        All animals exhibiting clinical signs of M. avium paratuberculosis must be tested and isolated from the herd pending the test results.  An organism detection test (i.e., fecal culture or PCR) must be used on feces from animals exhibiting clinical signs.

B)        A negative result on the M. avium paratuberculosis detection test will allow the herd to move to the next certification level.

5)         Suspension or revocation of herd certification:

A)        Identification of positive animals

i)          Identification

Identification of a positive animal using the organism detection test during the certification herd test will result in the loss of certification status.  The next negative test will qualify the herd for Level 1 certification.

ii)         Confirmation

If a positive animal is detected on any other test for Johne's disease during the current certification period other than by an organism detection test, the herd's certification will be suspended pending a confirmatory organism detection test of that animal.

B)        Herds not tested within 14 months after the last sampling will lose their certification status.  The next negative herd test will qualify the herd for Level 1 certification.

6)         Herd Additions.  Animals purchased from another herd participating in a M. avium paratuberculosis certification program may enter the herd without further testing, and will be tested along with the herd at the next annual test.  Animals originating from herds that are not participating in a M. avium paratuberculosis certification program must be isolated from the other members of the herd until a negative organism detection test has been received.  Isolation means that the animal can have no opportunity to share feed or water receptacles with other members of the herd, and there can be no chance of fecal contamination from the animal.

7)         Protocol. If an animal sold from a certified herd is identified as positive:

A)        If an animal sold from a certified negative herd is identified as positive by an organism detection test within 16 months after the date of sale, the selling certified herd  may, within 120 days after being notified, be required to conduct a herd retest of all eligible animals. Determination of retesting of the herd will be made by the Director based upon, but not limited to, the level of certification of the herd, the last negative organism detection test of the herd and the status of the other animals in the purchasing herd, if known.

B)        The selling certified herd will maintain its present certification status pending the results of the herd test or at the determination of the Director based on epidemiological evidence provided by a state or federal veterinarian.

C)        If the herd retest is negative, the herd will maintain its "present" certification status.  The herd owner/manager shall then have the option of maintaining his/her present test schedule or rescheduling his/her herd test date so that his/her next herd test is not due until 12 months after the retest.

D)        If a positive animal is identified on this retest, the selling herd will lose its certification status.  The next negative herd test will qualify the herd for Level 1 certification.

(Source:  Amended at 40 Ill. Reg. 2682, effective January 22, 2016)