NOTICES
DEPARTMENT OF AGRICULTURE
General Quarantine Order; Rabbit Hemorrhagic Disease Vaccine
[52 Pa.B. 838]
[Saturday, February 5, 2022]Recitals
A. Rabbit Hemorrhagic Disease (RHD) is a fatal disease of domestic and wild rabbits of the family Leporidae, which includes hares, jackrabbits and cottontails. RHD is caused by a calicivirus and there are several strains of RHD virus which cause disease.
B. Rabbit Hemorrhagic Disease Virus Serotype 2 (RHDV-2) is highly contagious and affects both domestic and wild rabbits.
C. There is no known cure or treatment for this disease.
D. Outbreaks of RHDV-2 have been reported in domestic and wild rabbits in the United States.
E. The virus causing RHD can be transmitted by direct contact with infected rabbits or indirectly through carcasses, food, water, and any contaminated materials, and it is very resistant to extreme temperatures. RHD has not been shown to affect people or other mammals.
F. Infected rabbits often show few clinical signs and die within six to 24 hours after the onset of fever and may have blood visible around the nose and other orifices due to internal hemorrhaging. The morbidity rate is often 100%, and the mortality rate is often 60%—90%.
G. Under the Domestic Animal Law at, 3 Pa.C.S. § 2321(d) (relating to dangerous transmissible diseases), the Department has authority to declare a disease, that has not been specifically identified in the statute as a ''dangerous transmissible disease,'' to be a dangerous transmissible disease through issuance of a Temporary Order making that designation.
H. The Department issued a Temporary Order, through publication in the Pennsylvania Bulletin on January 16, 2021 (51 Pa.B. 334), and renewed on December 4, 2021 (51 Pa.B. 7496) designating RHD as a dangerous transmissible disease.
I. RHD is currently considered a foreign animal disease in the United States.
J. The Pennsylvania Department of Agriculture (Department) has broad authority under the Domestic Animal Law (3 Pa.C.S. §§ 2301—2389) to regulate the keeping and handling of domestic animals to exclude, contain or eliminate dangerous transmissible diseases such as RHD.
K. The Department also has broad authority under the Domestic Animal Law to establish and enforce a General Quarantine Order against any area or locality within the Commonwealth of Pennsylvania (Commonwealth) to exclude, contain or eliminate dangerous transmissible diseases such as RHD. (3 Pa.C.S.A. § 2329(d)).
L. There is no fully licensed vaccine available to protect rabbits against RHD in the United States, however an inactivated (killed) recombinant subunit Rabbit Hemorrhagic Disease Virus vaccine, Rabbit Hemorrhagic Disease Vaccine, Serotype 2, is available from Medgene Labs, 1006 32nd Avenue, Suite 104, Brookings, SD 57006, and has been approved by the Department for sale and distribution to licensed veterinarians in Pennsylvania.
Order of Quarantine
With the foregoing recitals incorporated into this Order by reference, the Pennsylvania Department of Agriculture under authority of the Domestic Animal Law, at 3 Pa.C.S.A. § 2329(d) and § 1702 of the Administrative Code of 1929 (71 P.S. § 442), hereby establishes a General Quarantine Order (''Quarantine Order'') related to the dangerous transmissible disease Rabbit Hemorrhagic Disease and the sale, distribution and administration of the Rabbit Hemorrhagic Disease Virus vaccine, Rabbit Hemorrhagic Disease Vaccine, Serotype 2 available from Medgene Labs, 1006 32nd Avenue, Suite 104, Brookings, SD 57006 (''RHD Vaccine'') in the Commonwealth of Pennsylvania. Compliance and assurance of compliance with the provisions and terms of this Quaran-tine Order shall be the responsibility of all persons, individuals and entities subject to its terms. The terms of this Quarantine Order are as follows:
1. Quarantine Area. This General Quarantine Order (''Quarantine Order'') is applicable to the entire Commonwealth of Pennsylvania.
2. Applicable definitions.
Rabbit—For the purpose of this document, the term ''rabbit'' will include domestic rabbits of the family Leporidae, which includes hares, jackrabbits and cottontails.
VCPR—Veterinarian-client-patient-relationship (VCPR). As defined in the PA Veterinary Medicine Practice Act, a relationship satisfying all of the following conditions: (i) the veterinarian has assumed the responsibility for making veterinary medical judgments regarding the health of an animal and the need for veterinary medical treatment, and the client, owner or caretaker of the animal has agreed to follow the instructions of the veterinarian; (ii) the veterinarian has sufficient knowledge of the animal to initiate at least a general, preliminary or tentative diagnosis of the medical condition of the animal; (iii) the veterinarian is acquainted with the keeping and care of the animal by virtue of an examination of the animal or medically appropriate and timely visits to the premises where the animal is kept; (iv) the veterinarian is available for consultation in cases of adverse reactions to or failure of the regimen of therapy; (v) the veterinarian maintains records on the animal examined in accordance with regulations established by the board.
3. General Provisions.
(a) This Quarantine Order provides approval for the sale and distribution of the Rabbit Hemorrhagic Disease Virus vaccine, Rabbit Hemorrhagic Disease Vaccine, Serotype 2, manufactured by Medgene Labs, 1006 32nd Avenue, Suite 104, Brookings, SD 57006, only. As other vaccines become available and are approved by the Department this Quarantine Order may be amended.
(b) This Quarantine Order allows for and provides standards and approval for sale and distribution of the Rabbit Hemorrhagic Disease Virus vaccine, Rabbit Hemorrhagic Disease Vaccine, Serotype 2 in the Commonwealth of Pennsylvania to Pennsylvania licensed veterinarians only. Distribution or sale of the Rabbit Hemorrhagic Disease Virus vaccine, Rabbit Hemorrhagic Disease Vaccine, Serotype 2 to any other person shall be a violation of this Quarantine Order.
(c) On a quarterly basis Medgene Labs, 1006 32nd Avenue, Suite 104, Brookings, SD 57006 (''Manufacturer'') shall provide to the Department the following information for each veterinarian receiving the Rabbit Hemorrhagic Disease Virus vaccine, Rabbit Hemorrhagic Disease Vaccine, Serotype 2:
i. Name of Individual Veterinarian or Practice where applicable
ii. Address
iii. Each Veterinarian's License Number whether an individual or group practice
iv. Phone number and email address
v. Number of doses in each shipment
(d) The vaccine shall be administered according to the Manufacturer's label instructions to domestic animals of the Leporidae family only. Wild rabbits may not be vaccinated with this product.
(e) The sale of the Rabbit Hemorrhagic Disease Virus vaccine, Rabbit Hemorrhagic Disease Vaccine, Serotype 2 is restricted to licensed veterinarians for their clients with whom they hold a valid veterinarian-client-patient relationship (VCPR).
(f) The administration of vaccine shall be documented in the veterinary medical records in accordance with Pennsylvania's ''Veterinary Medicine Practice Act'' (Act of December 27, 1974, P.L. 995, No. 326) as amended) (63 P.S. § 485.1 et seq.).
(g) Records of vaccination shall be made available to the Department within 72 hours upon request.
4. In accordance with the Domestic Animal Law, at section 2327 (3 Pa.C.S.A. § 2327(b) and (c)(2), ''It shall be the duty of every practitioner of veterinary medicine and every diagnostic laboratory in this Commonwealth, immediately upon receiving information thereof, to report to the department each case of any dangerous transmissible disease. . .'' and ''It shall be unlawful for any person who has knowledge that a domestic animal is infected with a dangerous transmissible disease. . .to conceal or attempt to conceal such domestic animal or knowledge of such a domestic animal from the department.'' Therefore, any person who has information or knowledge that a domestic animal may be infected with RHD shall immediately notify the Pennsylvania Department of Agriculture, Bureau of Animal Health and Diagnostic Services at the following:
Kevin D. Brightbill, DVM ¦ State Veterinarian ¦ Director
Pennsylvania Department of Agriculture ¦ Bureau of Animal Health and Diagnostic Services
2301 North Cameron Street ¦ Harrisburg, PA 17110
Phone: 717.772.28525. Violations/Penalties. Any person violating the requirements of this Quarantine Order shall be subject to enforcement and penalties as are allowed under the provisions of the Domestic Animal Law (3 Pa.C.S.A. § 2301 et seq.), which include, revocation of license, criminal prosecution, issuance of civil penalties of up to $10,000 per violation, injunctive relief or all or any combination of such penalties.
6. No Restriction on Further Action by the Department. This Quarantine Order shall not be construed as limiting the Department's authority to establish additional quarantine or testing requirements or take any actions otherwise permitted under applicable statute or regulation.
7. Contact information. Questions regarding this General Quarantine Order may be addressed to the Commonwealth of Pennsylvania, Department of Agriculture, Bureau of Animal Health, 2301 North Cameron Street, Harrisburg, PA 17110; or by telephone at 717-772-2852; or by email at RA-ahds@pa.gov.
8. Effective Date. This Order is effective immediately upon publication in the Pennsylvania Bulletin and shall remain in effect unless rescinded or modified by subsequent order.
RUSSELL C. REDDING,
Secretary
[Pa.B. Doc. No. 22-198. Filed for public inspection February 4, 2022, 9:00 a.m.]
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