NOTICES
DEPARTMENT OF AGRICULTURE
General Quarantine Order; Chronic Wasting Disease Program Requirements for Herd Certification Program and Herd Monitoring Program Recitals
[44 Pa.B. 1011]
[Saturday, February 22, 2014]A. Chronic Wasting Disease (CWD) is considered an infectious, progressive and always fatal disease of susceptible species of the genera Cervus, Odocoileus and Alces including elk, white-tailed deer, moose, mule deer, black-tailed deer, sika deer, red deer and hybrids thereof.
B. There is no known treatment for CWD infection, no successful vaccine against this disease and no reliable live animal test for this disease.
C. CWD is believed to be transmissible from infected to uninfected cervids by ingestion of infected or contaminated materials occurring through shared environment or close contact.
D. CWD has been designated a ''dangerous transmissible disease'' of animals by order of the Secretary of Agriculture under the provisions of the Domestic Animal Law (Law) (3 Pa.C.S. §§ 2301—2389), at 3 Pa.C.S. § 2321(d).
E. The Department of Agriculture (Department) has broad authority under the Law to regulate the keeping, transport and handling of domestic animals to exclude, contain or eliminate dangerous transmissible diseases, such as CWD.
F. The Department also has broad authority under the Law to prohibit the importation of domestic animals, conveyances, containers, goods, products or materials in an effort to keep dangerous transmissible diseases, such as CWD, from entering this Commonwealth.
G. CWD may negatively impact this Commonwealth's wild and domestic (farmed or captive) cervid populations. CWD is of particular concern to the captive/farmed cervid industry, in that presence of CWD infection in a herd has resulted in the destruction of an entire herd and severely limited the market for product within and outside this Commonwealth.
H. In 2012, CWD infection was confirmed in two domestic white-tailed deer on a farm in the Commonwealth. CWD was diagnosed in free ranging deer in the Commonwealth from testing done in association with the Pennsylvania Game Commission's 2012 hunter harvest program. It has also been detected in cervids in Maryland, New York, Virginia, and West Virginia, and is known to be present in a number of other states and several Canadian provinces.
I. On August 4, 2006, the Department issued a General Quarantine Order addressing the CWD threat. That General Quarantine Order, published at 36 Pa.B. 4612 (August 19, 2006), required persons who own or maintain one or more CWD-susceptible animals to enroll and participate in either the CWD Herd Certification Program or the CWD Herd Monitoring Program.
J. On February 4, 2011, the Department rescinded and supplanted the referenced August 4, 2006 General Quarantine Order to reflect the experience the Department had gained in administering the referenced General Quarantine Order, as well as its current understanding of the threat posed by CWD. That General Quarantine Order, published at 41 Pa.B. 727 modified requirements to the mandatory CWD Herd Certification and the CWD Herd Monitoring Programs to improve disease control procedures in the Commonwealth.
K. On October 19, 2013, the Department published a revised General Quarantine Order, at 43 Pa.B. No. 42, 6218 (October 19, 2013) which rescinded and supplanted the referenced February 4, 2011, General Quarantine Order. The purpose of the October 19, 2013 General Quarantine Order was to harmonize Commonwealth program standards with Federal regulations in 9 CFR Parts 55 and 81 which establish minimum national standards addressing State CWD herd certification programs for interstate cervid commerce and to impose improved disease control and monitoring procedures intended to better contain the spread of CWD in the captive deer population.
L. By this General Quarantine Order, the Department is rescinding and supplanting the referenced October 19, 2013, General Quarantine Order in order to allow the regulated community a time period to understand and come into compliance with the new provisions, to more clearly and effectively establish a date by which the regulated community must come into compliance with the provisions of this General Quarantine Order and to clarify provisions of the October 19, 2013, General Quarantine Order related to specific due dates for annual inventory reports, duty of the program participant to provide such annual reports and aspects of the whole herd inventories required to be done by program participants utilizing Accredited Category II veterinarians. This General Quarantine Order and all of its provisions shall become effective as of August 1, 2014, by which time the regulated community shall be in compliance with all aspects of this General Quarantine Order. By this General Quarantine Order, the Department hereby reinstates the provisions of the February 4, 2011 General Quarantine Order, published at 41 Pa.B. 727 (February 5, 2011), until such time, August 1, 2014, as this General Quarantine Order shall become effective.
Order of General Quarantine
With the foregoing recitals incorporated into this General Quarantine Order by reference, the Department hereby establishes a General Quarantine under authority of the Domestic Animal Law, at 3 Pa.C.S. § 2329(d). The terms of this General Quarantine Order are as follows:
1. Quarantine Area. This General Quarantine Order is applicable to the entire Commonwealth of Pennsylvania.
2. October 19, 2013 and February 4, 2011 General Quarantine Order; Chronic Wasting Disease Program. The October 19, 2013 General Quarantine Order; Chronic Wasting Disease Program Requirements for Herd Certification Program and Herd Monitoring Program, published at 43 Pa.B. No. 42 6218 (October 19, 2013) is hereby rescinded and supplanted by this General Quarantine Order. In addition, the February 4, 2011 General Quarantine Order; Chronic Wasting Disease Program, published at 41 Pa.B. 727 (February 5, 2011), is hereby reinstated by this General Quarantine Order, until such date, August 1, 2014, as the provisions and requirements of the Herd Certification Program (established by Section 9. of this General Quarantine Order) and the Herd Monitoring Program (established by Section 10. Of this General Quarantine Order) become effective. All persons or businesses that own or maintain one or more of any of the CWD-susceptible species of the genera Cervus, Odocoileus or Alces including elk, white-tailed deer, moose, mule deer, black-tailed deer, sika deer, red deer or hybrid thereof, in captivity within this Commonwealth shall continue to be required to be enrolled in and follow the requirements of either the CWD Herd Certification Program or the CWD Herd Monitoring Program. Persons, premises and animals that were enrolled in either the CWD Herd Certification Program or the CWD Herd Monitoring Program under authority of the February 4, 2011 General Quarantine Order shall remain enrolled under the authority of that General Quarantine Order until such time as they meet the program enrollment requirements of this General Quarantine Order, as set forth in Sections 3. through 8. herein. All enrolled herds shall be subject to the terms and requirements of this General Quarantine Order upon their effective dates as set forth in Section 14. herein.
3. Election of Program and Compliance.
a. Election of Program and Enrollment. All persons subject to this General Quarantine Order, as set forth in Subsection 4.a. of this General Quarantine Order, shall file a Program Enrollment Form with the Department within the time period established in Subsection 3.b. (related to election of program and compliance). Failure to enroll in the program, file a program enrollment form, file a complete program enrollment form or comply with the enrollment requirements established herein, shall be a violation of this General Quarantine Order and subject the person to such penalties as are authorized under the Domestic Animal Law (3 Pa.C.S.A. § 2301 et seq.)
b. Election of program and compliance. Both currently enrolled and new herds subject to this General Quarantine Order shall file a program enrollment form with the Department within the time periods established below. Program enrollment is open upon publication of this General Quarantine Order in the Pennsylvania Bulletin.
i. Persons Currently Enrolled. Persons currently enrolled under the Herd Certification or Herd Monitoring Program established under the authority of the February 4, 2011 General Quarantine Order, shall be afforded a time period, until August 1, 2014, to complete the program enrollment process required by this General Quarantine Order and elect a program under this General Quarantine Order. All previously enrolled participants in the 2011 General Quarantine Order shall complete a new program enrollment application, which shall include selection of the program—Herd Certification Program or Herd Monitoring Program—they wish to be enrolled under—and return it to the Department, at the address set forth in Section 6 (related to obtaining a program enrollment form) of this General Quarantine Order by the August 1, 2014 deadline.
A. Enrollment time period. Persons currently enrolled under the Herd Certification or Herd Monitoring Program established under the authority of the February 4, 2011 General Quarantine Order may choose to complete the enrollment process required by this General Quarantine Order and elect a program at any time prior to the August 1, 2014 deadline.
B. Election of program. Those persons currently enrolled under the CWD Herd Certification Program may elect to continue under the CWD Herd Certification Program established by this General Quarantine Order and be subject to the requirements set forth herein or may downgrade the captive herd and enroll in the Herd Monitoring Program established by this General Quarantine Order and be subject to the requirements set forth herein. Persons may also elect to upgrade from the Herd Monitoring Program to the Herd Certification Program. After enrollment, currently enrolled program participants, electing the voluntary Herd Certification Program may, at the Department's discretion, elect to change the anniversary date for subsequent years to meet the requirements of the Herd Certification Program. Any such request for a change in anniversary date shall be in writing signed by the program participant and mailed to the Department at the address set forth in Section 6 (related to obtaining a program enrollment form) of this General Quarantine Order.
C. Compliance. Persons currently enrolled under the Herd Certification or Herd Monitoring Program established under the authority of the February 4, 2011 General Quarantine Order shall have until August 1, 2014 to both elect a level of participation and within which to come into compliance with any new or different requirements imposed by this General Quarantine Order.
ii. Persons Not Currently Enrolled or New Participants. All persons not currently enrolled in the Herd Certification or Herd Monitored Program established under the authority of the February 4, 2011 General Quarantine Order which own or maintain one or more of any CWD susceptible species in captivity or new participants which seek to own or maintain one or more of any CWD susceptible species in captivity, shall immediately file a program enrollment form with the Department. Such persons shall be subject to the requirements of the February 4, 2011 General Quarantine Order until such time as the provisions of the Herd Certification Program (established by Section 9. of this General Quarantine Order) and the Herd Monitoring Program (established by Section 10. of this General Quarantine Order) become effective.
4. Program Enrollment Requirement.
a. Any person or business that owns or maintains one or more of any of the CWD-susceptible species of the genera Cervus, Odocoileus or Alces including elk, white-tailed deer, moose, mule deer, black-tailed deer, sika deer, red deer or hybrids thereof, in captivity within this Commonwealth shall enroll in one of two programs—CWD Herd Certification Program and CWD Herd Monitoring Program—established under this General Quarantine Order. Enrollment in the CWD Herd Certification Program is not mandatory. A person may choose to voluntarily enroll in the CWD Herd Certification Program and adhere to the more stringent requirements established under that program. A person who does not choose to enroll in the CWD Herd Certification Program, shall be required to enroll in the CWD Herd Monitoring Program.
b. A person required to adhere to the provisions of this General Quarantine Order shall provide the Department with a completed program enrollment form, as described in Sections 5 through 8 (related to meeting the program enrollment requirement; required adherence to Herd Certification or Herd Monitoring protocols, obtaining a program enrollment form, contents of the program enrollment forms, delivering the program enrollment form) of this General Quarantine Order. The program enrollment form utilized shall be the form developed and approved by the Department. The program enrollment form will be available on the Department's website (www.agriculture.state.pa.us) and will be made available in paper form for those not having internet access. The requirements of this General Quarantine Order are applicable to any type of location or operation at which CWD-susceptible cervids are maintained, including private residences, farms, hunting ranches, zoological displays and menageries. Each separate location, operation and herd will be assigned a state premises identification number which identifies that individual herd's status. The state premises identification number begins with 'PA' and followed by six alphanumeric characters.
c. When multiple program herds reside on the same premises, or where herds owned by the same person reside on more than one premises, a separate Program Enrollment Form shall be required for each program herd on each premises, which shall mean each separate level of Certified Status and each Monitoring herd held in captivity. For example, where one herd of CWD-susceptible species will be enrolled in the CWD Herd Certification Program and another is enrolled in the CWD Herd Monitoring Program, a separate Program Enrollment Form shall be required for each of those herds denoting a different program. Separation between perimeter fences shall be no less than 30 feet for animals on different programs for the same participant or between different participants.
d. Prior to transferring or bringing a CWD-susceptible species onto a premises not currently or not previously enrolled in the CWD program, a person shall submit to an inspection of the premises prior to approval of such premises to hold and maintain a CWD-susceptible species. Such inspection shall be carried out by a PDA official in order to assure the person has proper enclosures and fencing to maintain the CWD-susceptible species so as to prevent ingress and egress of cervids. Failure to submit to such an inspection or the failure to have erected proper enclosures and fencing in a manner that will prevent ingress and egress of cervids may result in any or all of the following actions:
i. The denial of the addition of a CWD-susceptible species to the premises;
ii. Criminal or civil penalties as allowed under the Law;
iii. Equitable relief as allowed under the Law;
iv. Such other action as allowed under the Law.
5. Meeting the Program Enrollment Requirement; Required Adherence to Herd Certification or Herd Monitoring Protocols. Farmed or captive CWD-susceptible cervids present on each premises described in Section 4 (related to program enrollment requirement) shall be enrolled by the cervid owner in either the CWD Herd Certification Program or the CWD Herd Monitoring Program (which are described as follows). A cervid owner who is required to enroll one or more CWD-susceptible cervids under this General Quarantine Order, and who enrolls the animals in either the CWD Herd Certification Program or the CWD Herd Monitoring Program, shall be referred to as a ''program participant'' throughout this General Quarantine Order. The program participant shall be responsible to maintain the subject animal or herd in compliance with all of the requirements of the program in which it is enrolled. The Department will promptly mail or deliver program enrollment forms to any person who requests the forms. Enrollment shall be completed by delivering a completed program enrollment form to the Department by any of the means described in Section 8 (related to delivering the program enrollment form).
6. Obtaining a Program Enrollment Form. The program enrollment forms described in Section 7 (related to contents of the program enrollment forms) (for either the CWD Herd Certification Program or the CWD Herd Monitoring Program) may be obtained by:
a. Telephoning the Department at (717) 783-5309 and requesting that a form be provided by mail or fax.
b. Mailing or presenting a request to the Department at the following address:
Pennsylvania Department of Agriculture
ATTN: CWD Program Manager, Animal Health
2301 North Cameron Street
Harrisburg, PA 17110-9408c. Downloading the forms from the Department's website (www.agriculture.state.pa.us).
7. Contents of the Program Enrollment Forms
a. CWD Herd Certification Program. The program enrollment form for the CWD Herd Certification Program shall require the following information:
i. Mailing address and contact information to include the name, address, telephone number and where applicable, the e-mail address of each person who owns or maintains an ownership interest in the operation or business and in each subject farmed or captive cervid. Where the operation or business is other than a sole proprietorship, the name, title and ownership interest of each person who is part of the business structure or involved in the operation or business shall be set forth, along with the names of any hired managers or authorized agents.
ii. Physical address of premises, which shall be the physical address of the premises on which the captive cervids are located and shall be a street address (P. O. Boxes will not be accepted) at which each subject cervid is maintained in captivity or driving directions to the premises if there is no street address where each subject cervid is maintained.
iii. Structure of the organization or operation, such as, corporation, limited liability corporation, S corporation, partnership, limited partnership, individual/sole proprietor, or other business structure, along with the name of the cervid operation, including any fictitious name (if applicable).
iv. The Cervidae Livestock Operation license number (where applicable).
v. The premises identification number (where one has been assigned).
vi. Number of cervids maintained on the premises, by species.
vii. All official and unofficial identification (as described in Subsection 9.j.) (related to identification of subject animals), sex and date of birth of each subject cervid.
viii. The date of acquisition and source, including contact information (name and complete address, as well as telephone number and where available email address), of each subject cervid that was not born into the herd.
ix. A listing of and the date of birth of any cervid that was born on the premises, as well as, any official or unofficial identification (as described in Subsection 9.j.) (related to identification of subject animals) that was attached to that cervid.
x. The location at which the records required under the Herd Certification Program shall be maintained and made available for inspection by the Department.
b. CWD Herd Monitoring Program. The program enrollment form for the CWD Herd Monitoring Program shall require the following information
i. Mailing address and contact information to include the name, address, telephone number and where applicable, the e-mail address of each person who owns or maintains an ownership interest in the operation or business and in each subject farmed or captive cervid. Where the operation or business is other than a sole proprietorship, the name, title and ownership interest of each person who is part of the business structure or involved in the operation or business shall be set forth, along with the names of any hired managers.
ii. Physical address of premises, which shall be the physical address of the premises on which the captive cervids are located and shall be a street address (P. O. Boxes will not be accepted) at which each subject cervid is maintained in captivity or driving directions to the premises if there is no street address where each subject cervid is maintained.
iii. Structure of the organization or operation, such as, corporation, limited liability corporation, S corporation, partnership, limited partnership, individual/sole proprietor, or other business structure, along with the name of the cervid operation, including any fictitious name (if applicable).
iv. The Cervidae Livestock Operation license number (where applicable).
v. The premises identification number (where one has been assigned).
vi. The number of each species of farmed or captive CWD-susceptible cervid on the premises. An estimate may be provided if the exact number cannot be determined.
vii. The date of acquisition and source of each subject cervid, including contact information (name and complete address, as well as telephone number and where available email address), including any form of identification on the subject cervid, that was not born into the herd.
viii. The location at which the records required under the Herd Monitoring Program shall be maintained and made available for inspection by the Department.
8. Delivering the Program Enrollment Form. A person required to file a program enrollment form under this General Quarantine Order shall deliver the completed signed form to the Department by faxing it to (717) 787-1868, or mailing or delivering it to the address set forth in Subsection 6.b. (related to obtaining a program enrollment form). Any changes to the information required by Subsection 7.a.i., ii., iii., iv., v. and x. or Subsection 7.b.i., ii., iii., iv., v. and viii. (related to contents of the program enrollment forms) shall be reported to the Department, in writing, within 30 days of such change occurring.
9. CWD Herd Certification Program.
a. Program established. The Chronic Wasting Disease Herd Certification Program (Herd Certification Program), as established by the August 19, 2006, General Quarantine Order; Chronic Wasting Disease Program, published at 36 Pa.B. 4612 (August 19, 2006) and amended by the February 4, 2011, General Quarantine Order; Chronic Wasting Disease Program, published at 41 Pa.B. 727 (February 5, 2011) and the October 19, 2013, General Quarantine Order; Chronic Wasting Disease Program Requirements for Herd Certification Program and Herd Monitoring Program, published at 43 Pa.B. 6218 (October 19, 2013) is hereby continued and modified by this General Quarantine Order in the manner established herein.
b. Voluntary Program. Enrollment in the CWD Herd Certification Program is purely voluntary for those with CWD susceptible species. The CWD Herd Certification Program establishes criteria which are more stringent than those required by the mandatory CWD Herd Monitoring Program. A participant voluntarily enrolling in the CWD Herd Certification Program shall be required to meet all of the criteria established thereunder or the Department, at its sole discretion, may:
i. Reduce or roll-back the program participant's ''Herd Status'' to a previous year or to ''First Year Status''; or
ii. Remove the program participant from the CWD Herd Certification Program and place the program participant in the CWD Herd Monitoring Program.
c. Status of Herd. The Herd Certification Program is a 5-year process by which a herd of farmed or captive CWD-susceptible cervids may achieve ''Fully Certified Status.'' The Department shall record the date of enrollment of a particular herd of farmed or captive CWD-susceptible cervids in the Herd Certification Program. The status of that enrolled herd shall be determined in the following manner:
i. First Year ''HC-1'' Status. A designation of ''HC-1'' shall be assigned to a herd of cervids enrolled in the Herd Certification Program for the first twelve (12) months from the date of enrollment of that herd of cervids in the Herd Certification Program. Only those cervids listed on the program participant's enrollment form and which have been verified through inspection, as set forth in Subsection 9.o. (related to department inspections) or a whole herd visual or hands-on inventory verification as set forth in Subsection 9.n. (related to whole herd visual or hands-on inventory verification) of this General Quarantine Order to bear the approved forms of identification shall be assigned a ''HC-1'' status. Failure to maintain compliance with all of the provisions of the Herd Certification Program may result in removal of the herd from the voluntary Herd Certification Program and placement into the mandatory Herd Monitoring Program, the imposition of civil or criminal penalties as allowed under Section 2383 of the Domestic Animal Law (3 Pa.C.S.A. § 2383) or any other equitable action established thereunder or any combination thereof.
ii. Subsequent Year Status. On the anniversary date of enrollment in each year following that date of initial enrollment the status of the program participant's herd may be upgraded by one year. The upgrade shall only occur if the program participant has maintained compliance and is currently in compliance with all of the requirements of the Herd Certification Program and the General Quarantine Order. The status of each subsequent twelve month period from the program participant's anniversary date, until reaching ''Fully Certified'' status, shall be designated as follows:
A. For months 13-24 the designation of ''HC-2'' shall be assigned to a herd that has maintained compliance with all of the requirements of the Herd Certification Program and the General Quarantine Order.
B. For months 25-36 the designation of ''HC-3'' shall be assigned to a herd that has maintained compliance with all of the requirements of the Herd Certification Program and the General Quarantine Order.
C. For months 37-48 the designation of ''HC-4'' shall be assigned to a herd that has maintained compliance with all of the requirements of the Herd Certification Program and the General Quarantine Order.
D. For the months 49-60 the designation of ''HC-5'' shall be assigned to a herd that has maintained compliance with all of the requirements of the Herd Certification Program and the General Quarantine Order.
E. Upon reaching 60 months from the initial anniversary date of the program participant, the designation of ''Fully Certified'' shall be assigned to a herd that has maintained compliance with all of the requirements of the Herd Certification Program and the General Quarantine Order.
iii. Fully Certified Status. On the anniversary date of the fifth year after the initial anniversary date (that is, after 5 consecutive years of program participation and compliance have been completed), the status of the program participant's herd may be upgraded to ''Fully Certified.'' The upgrade shall only occur if the program participant is in compliance with and has remained in compliance with all of the requirements of the CWD Herd Certification Program and the General Quarantine Order. The subject herd shall be classified as ''Fully Certified'' so long as the herd remains CWD-free and continues to maintain compliance with all provisions of the Herd Certification Program and this General Quarantine Order.
iv. Previously Enrolled Herds. The status of herds enrolled in the CWD Herd Certification Program under the February 4, 2011 Order of General Quarantine which are in compliance with that Order as of the effective date of this General Quarantine Order will maintain their existing certification status under this Order of General Quarantine if they elect to enroll in and agree to comply with the provisions of the CWD Herd Certification Program established under this Order of General Quarantine. If the program participant elects to withdraw his herd from the CWD Herd Certification Program, he shall enroll the herd in the CWD Herd Monitoring Program. Thereafter, any subsequent enrollment of the herd in the CWD Herd Certification Program shall result in the herd being assigned ''First Year Status'' and the 5-year process required to attain ''Fully Certified'' status shall begin again.
v. New herd assembled from current Herd Certification Program participants. If the herd is composed solely of animals obtained from herds already enrolled in the Program, the newly assembled herd will have the same status as the lowest status of any herd that provided animals for the new herd.
d. Duty to Report Suspects and Dead Cervids and Dead Cervids found in an advanced state of decomposition. The program participant, the owner of a herd of farmed or captive CWD-susceptible cervids and any caretaker of that herd shall report any suspect cervid, dead cervid or dead cervid found in an advanced state of decomposition as set forth herein. Failure to comply with any of the provisions of this subsection including, failure to report a suspect cervid, the death of a cervid within the time periods set forth herein or the discarding, removal or disposal of carcasses, parts, offal or tissues in a manner which is inconsistent with the provisions of this subsection or without the required verifications shall constitute a violation of this General Quarantine Order.
i. Suspect Cervid—Any cervid that shows signs that are consistent with CWD (such as staggering, drooling, wasting or unusual behavior) shall be immediately reported to the designated regional office of the Bureau of Animal Health in the Pennsylvania Department of Agriculture. The suspect cervid shall not be removed from the premises of the program participant until such time as the Department has been able to assess the animal and issue an order or guidance with regard to the holding, harvesting, testing and removal of such animal. Failure to immediately report a suspect cervid or abide by the removal provisions of this section shall constitute a violation of this General Quarantine Order.
ii. Dead cervid—Upon the discovery of any dead farmed or captive CWD-susceptible cervid aged 12 months or older, the program participant, owner or caretaker shall take the following steps and comport with the following protocols:
A. Record the death and include the animal as part of the Ongoing Annual Recordkeeping Requirements, established by Subsection 9.k. of this Order of General Quarantine.
B. Record the death and include the animal as part of the Ongoing Movement of Cervids Recordkeeping and Reporting Requirements, established by Subsection 9.l. of this Order of General Quarantine. Such information shall be reported within ten (10) business days of discovery of the death, on forms developed, approved and provided by the Department and shall set forth that information required by subparagraph 9.l.ix. of this Order of General Quarantine.
C. Have the dead cervid tested. The entire carcass, head or tissue samples from the carcass shall be transported for testing in accordance with the requirements of Subsections 9.f. or 9.g. (related to mandatory testing for farmed or captive CWD-susceptible cervids designated as CWD suspects, and testing protocol for other farmed or captive CWD-susceptible cervids), as applicable, of this General Quarantine Order.
iii. Dead cervid found in an advanced state of decomposition—Upon the discovery of any dead farmed or captive CWD-susceptible cervid aged 12 months or older, in an advanced state of decomposition, the program participant, owner or caretaker shall report this death to the designated regional office of the Department within 48 hours. The program participant, owner or caretaker shall take the following steps and comport with the following protocols:
A. The dead cervid, including all parts and offal, shall not be removed from the premises of the program participant, except that the entire carcass or head of the carcass may be transported for testing as set forth in Subsection 9.f.i. (related to mandatory testing for farmed or captive CWD-susceptible cervids designated as CWD suspects) of this General Quarantine Order or tissue samples may be collected and sent for testing as set forth at Subsection 9.f.ii. (related to mandatory testing for farmed or captive CWD-susceptible cervids designated as CWD suspects) of this General Quarantine Order.
B. Where only the head or tissue samples are sent for testing, the carcass, parts and offal of the dead cervid shall not be removed from the premises of the program participant until test results have been received or a determination made that the carcass is untestable and shall only be disposed of in a manner approved by and set forth in writing by the Department.
C. Dead cervid carcasses considered to be untestable by the program participant or owner shall be verified as such by a Department or a USDA, APHIS representative prior to removal or disposal of such carcass, parts and offal. The Department or USDA, APHIS representative may determine that the entire carcass shall be collected and moved directly to a laboratory for collection and potential testing.
iv. Failure to abide by the requirements of this Subsection d. (related to duty to report suspects and dead cervids and dead cervids found in an advanced state of decomposition) shall be a violation of this General Quarantine Order and may result in the imposition of such criminal and civil penalties and remedies as allowed under the Domestic Animal Law (3 Pa.C.S.A. §§ 2380.8, 2383 and 2386) and the reduction of Herd Certification Program status or cancellation of program enrollment and placement in the mandatory Herd Monitoring Program.
e. Mandatory Testing. A program participant with a herd that is enrolled in the Herd Certification Program shall be responsible to ensure that a farmed or captive CWD-susceptible cervid is tested in accordance with Subsection 9.f. (related to mandatory testing for farmed or captive CWD-susceptible cervids designated as CWD suspects) or 9.g. (related to testing protocol for other farmed or captive CWD-susceptible cervids), as applicable, if any of the following occur after the date of enrollment in the Herd Certification Program:
i. The cervid shows signs (such as staggering, drooling, wasting or unusual behavior) that are consistent with CWD and the cervid dies or is killed.
ii. The cervid is 12 months of age or older and is sent to a slaughter facility.
iii. The cervid is 12 months of age or older and dies for any reason (including accident, natural causes, slaughter, harvesting, hunting, culling or any other cause).
f. Mandatory Testing for Farmed or Captive CWD-Susceptible Cervids designated as CWD Suspects. If a dead farmed or captive CWD-susceptible cervid is required to be tested because it showed signs (such as staggering, drooling, wasting or unusual behavior) that are consistent with CWD before it died or was killed, as described in Subsection 9.e.i. (related to mandatory testing), it shall be tested according to either of the following procedures:
i. A person shall immediately notify the Department of the dead CWD-susceptible cervid and do the following:
A. Collect either the entire carcass of the cervid or the entire head of the cervid with official identification devices attached in situ.
B. Deliver the carcass or head with official identification devices attached in situ for CWD testing. The properly completed chain of custody forms and sample submission forms required under Subsection 9.i. (related to chain of custody of samples; submission of samples) of this General Quarantine Order shall accompany the carcass or head. The carcass or head shall bear a proper form of identification and be delivered within 72 hours of the cervid's death to either a Department laboratory or to a laboratory that has been approved in advance by the Department or USDA or both, to perform CWD testing. Results of samples submitted without the proper and required official identification or the properly completed chain of custody forms and sample submission forms may not be recognized by the Department in determining herd certification status and shall be considered a violation of this General Quarantine Order. Any such violation may result in the imposition of such criminal and civil penalties and remedies as allowed under the Domestic Animal Law (3 Pa.C.S.A. §§ 2380.8, 2383 and 2386) as well as the reduction of Herd Certification Program status or cancellation of program enrollment and placement in the mandatory Herd Monitoring Program.
ii. As an alternative to the CWD testing procedure described in paragraph (i), the following procedure shall be followed:
A. Tissue samples shall be collected by one of the following:
I. A USDA, APHIS Category II accredited practitioner of veterinary medicine.
II. An authorized State official. A Department-certified CWD Sampling Technician does not meet the requirements of this subparagraph.
III. An authorized Federal official.
B. Tissue samples shall be collected and preserved within 72 hours of the cervid's death.
C. Tissues samples shall consist of the obex and the medial retropharyngeal lymph nodes preserved in formalin; and in a separate container that does not contain formalin or any other preservative, a small portion of the ear or other skin that is attached to the official identification of the subject cervid.
D. The tissue samples shall be delivered within 72 hours of the cervid's death to the Pennsylvania Veterinary Laboratory or to a laboratory that has been approved in advance by the Department or USDA or both, for CWD testing. It is the owner's responsibility to report the death within a time frame that allows for collection and preservation of the tissue samples within 72 hours of the cervid's death as required by Subsection B. above and protect the carcass from further degradation until tissue samples can be collected.
E. Properly completed chain of custody forms and sample submission forms as required under Subsection 9.i. (related to chain of custody of samples; submission of samples) of this General Quarantine Order shall accompany the tissue samples.
g. Testing Protocol for Other Farmed or Captive CWD-Susceptible Cervids. If a farmed or captive CWD-susceptible cervid does not exhibit signs (as described in Subsection 9.d.i. (related to duty to report suspects and dead cervids and dead cervids found in an advanced state of decomposition)) that are consistent with CWD, and is required to be tested because it is 12 months of age or older and was either sent to a slaughter facility or died for any reason, as described in Subsections 9.e.ii. and 9.e.iii. (related to mandatory testing), the Department shall be notified by the program participant, who shall send the Department records setting forth the official identification of each farmed or captive CWD-susceptible cervid that was sent to slaughter or died for any reason set forth in Subsection 9.e.ii. and 9.e.iii. (related to mandatory testing), along with the name and address of the slaughter facility where each animal was slaughtered or the name and address of the place where the animal died or was harvested and the cause of death. In such cases, each farmed or captive CWD-susceptible cervid shall be tested according to the following procedures:
i. Tissue samples shall be collected by one of the following:
A. A USDA, APHIS Category II accredited practitioner of veterinary medicine.
B. An authorized State official.
C. An authorized Federal official.
D. A Department-certified CWD Sampling Technician.
ii. Tissue samples shall be collected and preserved within 72 hours of the cervid's death.
iii. Tissues samples shall consist of the obex and the medial retropharyngeal lymph nodes preserved in formalin; and in a separate container that does not contain formalin or any other preservative, a small portion of the ear or other skin that is attached to the official identification of the subject cervid.
iv. Properly completed chain of custody forms and sample submission forms as required under Subsection 9.i. (related to chain of custody of samples; submission of samples) of this General Quarantine Order shall accompany the tissue samples.
v. The tissue samples shall, within 30 days of collection, be delivered to the Pennsylvania Veterinary Laboratory or to a laboratory that has been approved in advance by the Department or USDA, or both, to perform CWD testing.
vi. As an alternative to the testing protocol described in paragraphs i, ii, iii, iv and v of this Subsection 9.g. (related to testing protocol for other farmed or captive CWD-susceptible cervids), the following protocols shall be followed:
A. Within 72 hours of the cervid's death, collect and deliver either the entire carcass of the cervid with official identification devices attached in situ or the entire head of the cervid with official identification devices attached in situ to a Department laboratory for CWD testing, or to a laboratory that has been approved in advance by the Department or USDA or both to perform CWD testing.
B. The program participant/herd owner shall be responsible for properly identifying the cervid carcass or head and delivering it in a manner that does not destroy or make the animal untestable.
C. The person who delivers the carcass or head need not be an approved tissue collector as described in Subsection 9.g.i. (related to testing protocol for other farmed or captive CWD-susceptible cervids).
D. The name, address and signature of the person collecting, or the person in possession of the carcass, and the person delivering the carcass or head shall be set forth in writing and such writing shall be attached to the chain of custody forms and sample submission forms required by this General Quarantine Order.
E. The properly completed chain of custody forms and sample submission forms required under Subsection 9.i. (related to chain of custody of samples; submission of samples) of this General Quarantine Order shall accompany the carcass or head.
F. Results of samples submitted without the proper and required official identification or the properly completed chain of custody forms and sample submission forms may not be recognized by the Department in determining herd certification status and shall be considered a violation of this General Quarantine Order. Any such violation may result in the imposition of such criminal and civil penalties and remedies as allowed under the Domestic Animal Law (3 Pa.C.S.A. §§ 2380.8, 2383 and 2386), as well as the reduction of Herd Certification Program status or cancellation of program enrollment and placement in the mandatory Herd Monitoring Program.
h. Impact of Late Notice, Delivery or Untestable Samples on Enrollment Status.
i. It is the program participant/herd owner's responsibility to assure good quality tissue is submitted for testing and ensure that all required samples are collected properly and in a timely manner as required by Subsections 9.f. (related to mandatory testing for farmed or captive CWD-susceptible cervids designated as CWD suspects) and 9.g. (related to testing protocol for other farmed or captive CWD-susceptible cervids) of this General Quarantine Order. All required tissues shall be collected regardless of sample condition (e.g. autolyzed or frozen). In cases where sample quality is poor, the Department shall be notified and a determination made on samples to be submitted.
ii. Failure to abide by the requirements of this section shall be a violation of this General Quarantine Order and may result in the imposition of such criminal and civil penalties and remedies as allowed under the Domestic Animal Law (3 Pa.C.S.A. §§ 2380.8, 2383 and 2386) and the reduction of Herd Certification Program status or cancellation of program enrollment and placement in the mandatory Herd Monitoring Program. Where the history of sample collections and submissions from the program participant/herd owner demonstrates a pattern of lack of submission of required samples, untimely submission of samples or poor performance including incorrect tissues submitted, poor tissue quality, or non-compliance with the provisions and requirements of Subsections 9.e. (related to mandatory testing), 9.f. (related to mandatory testing for farmed or captive CWD-susceptible cervids designated as CWD suspects) and 9.g. (related to testing protocol for other farmed or captive CWD-susceptible cervids) of this General Quarantine Order, the Department may seek such additional remedies, including injunctive relief as is allowed under the Domestic Animal Law. Adherence to the 72-hour deadlines established in Subsections 9.f.i.B, f.ii.B. f.ii.D. (related to mandatory testing for farmed or captive CWD-susceptible cervids designated as CWD suspects) and g.ii. and g.vi.A. (related to testing protocol for other farmed or captive CWD-susceptible cervids) will be considered a mitigating factor by the Department in any reevaluation of herd status.
i. Chain of Custody of Samples; Submission of Samples. A person may obtain chain of custody forms and sample submission forms from the Department by submitting a written request for such forms or by downloading the forms from the Department's website (www.agriculture.state.pa.us).
i. A person submitting a sample (whether tissue samples, an entire carcass or an entire head) for testing under the Herd Certification Program shall complete a chain of custody form and a sample submission form, and shall submit those forms along with the sample that is delivered for testing.
ii. The chain of custody form shall clearly identify the premises, including the address of the premises and the name and signature of the herd owner, on which the cervid resided and from which it was taken, official identification of the cervid, the date of sampling, and the persons (in chronological order) who handled the sample from the point it was taken until it is delivered to the Pennsylvania Veterinary Laboratory or a Department-approved laboratory or a USDA-approved laboratory for CWD testing.
iii. The chain of custody form shall bear the signature, printed name and other identifying information with respect to each person who handles the sample.
iv. The completed chain of custody form and the sample submission form shall be provided to a responsible person at the laboratory to which the sample is delivered.
j. Identification of Subject Animals. Each farmed or captive CWD-susceptible cervid that is within a herd enrolled in the Herd Certification Program and is either 12 months of age or older or is transported alive from the enrolled premises regardless of its age at the time of movement shall have at least two forms of the Department and USDA, APHIS-approved animal identification attached. One form of identification shall be official. In accordance with 9 CFR Parts 71, 77, 78, and 86 ''Traceability for Livestock Moving Interstate,'' official identification shall not be removed from animals. If the other form of identification is not official, it shall be unique to the animal on the enrolled premises. Other forms of secondary identification in addition to being unique to the animal in the herd, must be permanent and tamper-resistant. If duplicate (non-unique to the animal in the herd) secondary identification occurs, that duplication shall be resolved, corrected in the inventory paperwork, and promptly reported to the Department. Forms of identification that are Department-approved and USDA, APHIS-approved, ''official'' forms of identification for purposes of this provision include the following:
i. A legible and unique tattoo approved by the Department and USDA, APHIS.
ii. A USDA, APHIS-issued ear tag, bearing a unique number provided by USDA, APHIS that utilizes one of the following numbering systems:
A. The National Uniform Eartagging System (NUES).
B. The Animal Identification Number (AIN) bearing 15 digits starting with '840.'
C. The premises-based numbering system using a Premises Identification Number (PIN) in conjunction with a livestock production numbering system.
D. Any other numbering system approved by USDA, APHIS and the state veterinarian.
iii. An electronic implant device, such as a microchip that utilizes a nationally unique 15 digit animal identification number starting with '840' provided an appropriate reader is immediately available wherever the animal is located.
iv. Any other identification device approved by the Department and USDA, APHIS.
k. Ongoing Annual Recordkeeping Requirements. A program participant with a herd that is enrolled in the Herd Certification Program shall maintain up-to-date herd inventory records with respect to the subject herd for a period of 5 years and shall make these records available for inspection by the Department upon request. The original record forms, once completed are to be submitted by the last day of the month comprising the program participant's anniversary date to the Department's headquarters in Harrisburg by mail, attached to an email or faxed. The participant must keep copies of all the submitted forms if the original forms have been submitted by mail or keep the original completed forms, when records are submitted electronically, for a period of 5 years and make them available upon request by Department officials. If the Department identifies discrepancies with the submitted records, a complete set of these records forms and incomplete forms shall be returned to the program participant with a deadline for completion. Each year the program participant shall provide a current, updated annual inventory report to the Department. The anniversary date for each current certified herd program participant shall remain the same as under the previous quarantine order, unless the program participant submits a request in writing to the Department to change the anniversary date. New certified herd program participant's anniversary dates shall be determined by the date of their initial enrollment in the program. Any anniversary date change will be at the Department's discretion. The annual inventory reports shall be kept and filed on forms developed, approved and provided by the Department. Such forms will be made available on the Department's website (www.agriculture.state.pa.us) and will be available in paper form for those program participants that do not have internet access. The program participant shall be required to complete all fields on the recordkeeping forms. These records shall include the following information with respect to each subject cervid:
i. Official identification placed, as previously described in Subsection 9.j. (related to identification of subject animals) for each cervid in the enrolled herd.
ii. Either the second official identification in accordance with 9 CFR Parts 71, 77, 78, and 86 ''Traceability for Livestock Moving Interstate'' or the unofficial identification that is unique to the animal on the enrolled premises, as previously described in Subsection 9.j. (related to identification of subject animals).
iii. The sex, date of birth and species of the subject cervid.
iv. The date of departure and the destination, of any subject cervid removed from the herd since the last anniversary date. Such records shall include all of the following information:
A. The contact information (name, complete address, telephone number and when available, email address) of the person to whom the cervid was sold, lent, leased, consigned, exchanged, bartered, gifted, boarded, moved including for breeding purposes, given, harvested or otherwise transferred.
B. The contact information (name, complete address, telephone number and where applicable, Pennsylvania Dealer/Hauler or Cervidae Livestock Operations license number or both where both types of licenses are held) of any dealer, hauler or broker or Pennsylvania cervid livestock operation utilized in such transaction. The license expiration date shall also be included.
C. The date of death and cause of death (if known) of any subject cervid that dies and the CWD test result for that animal.
v. If the subject cervid is new to the herd since the anniversary date designation of whether the subject was born to the herd or acquired from outside the herd. Those animals born to the herd, less than 12 months of age, and without any identification shall be counted and listed by number and gender. For example, four buck fawns and three doe fawns born in 2014. If the subject cervid was acquired from outside the herd the following information shall be provided:
A. The source of the subject cervid including contact information (name, complete address, telephone number, and when available, email address) of the source herd.
B. The date of acquisition.
C. Where a Pennsylvania dealer, hauler, or broker or a Pennsylvania cervid livestock operation was involved in the transaction, the name, complete address, telephone number and Pennsylvania Dealer/Hauler or Cervidae Livestock Operations license number or both where both types of licenses are held of such dealer, hauler, broker or Pennsylvania cervid livestock operation. The license expiration date shall also be included.
l. Ongoing Movement of Cervids Recordkeeping and Reporting Requirements. A program participant shall report any and all movements of CWD susceptible species of cervids onto and off of the premises (i.e. additions and deletions to the herd). Such reports shall:
i. Be filed on an ongoing basis with the Department and shall be filed within ten (10) business days of the movement of a CWD susceptible species of cervid onto or off of the program participant's premises.
ii. Be on forms developed, approved and provided by the Department.
iii. Be complete and shall contain all of the information requested by the Department.
iv. Set forth the type of transaction, which included sold, lent, leased, consigned, exchanged, bartered, gifted, boarded, moved including for breeding purposes, given, harvested or otherwise transferred and whether such transaction transferred ownership or mere possession of the cervid(s).
v. Set forth the reasons for the movement, including to a slaughter facility; movement to or from another Pennsylvania program participant, movement to or from a separately enrolled premises of the same Pennsylvania program participant; movement to or from an out of state person or any other reason for movement of the cervid(s) on to or off of the program participant's property.
vi. With regard to both the premises of origin and the premises of destination, include, at a minimum, the following information:
A. The program participant's name and mailing address, which shall match that which was provided on the program participant's enrollment forms.
B. The fictitious name (if applicable) of the program participant's cervid businesses, which shall match those which were provided on the program participant's enrollment forms.
C. The Pennsylvania premises identification number of the program participant's property (where applicable), which shall match that which was provided on the program participant's enrollment forms.
D. The address and physical location of the property to which the CWD susceptible species of cervid(s) were added and the address and physical location of the property from which the CWD susceptible species were deleted. Post office box addresses shall not be acceptable. Where the property is that of a Pennsylvania program participant, the Pennsylvania premises identification number shall be set forth.
E. Where the premises of origin or premises of destination is out of state, the name, address of the person and entity from which the cervid(s) was purchased or acquired or to which the cervid was sold or transferred; a copy of the certificate of veterinary inspection (CVI) accompanying each cervid; and a copy of the bill of sale or purchase; and the bill of lading. The address of the person from which the cervid(s) was purchased or acquired or to which the cervid was sold or transferred shall be a physical address and a post office box address shall not be acceptable.
F. Where the premises of destination is a slaughter facility, the name and address of the slaughter facility shall be set forth and a copy of the bill of sale and bill of lading shall be attached.
vii. Where a dealer, broker or hauler was utilized, include the name, address and contact information of the broker, hauler and dealer. Where such dealer, hauler or broker was a Pennsylvania dealer, hauler or broker, the Pennsylvania Dealer/Hauler license number and license expiration date shall be set forth. The address shall be a physical address and a post office box address shall not be acceptable
viii. The address and property owners name of any premises, other than the final premises of destination, to which the CWD susceptible species of deer were shipped or on which they were housed, held or stopped-over prior to reaching the final premises of destination. The address shall be a physical address and a post office box address shall not be acceptable.
ix. For each cervid include the following information:
A. The official identification of each subject animal meeting the requirements of Subsection 9.j. (related to identification of subject animals) of this General Quarantine Order.
B. Either the second official identification in accordance with 9 CFR Parts 71, 77, 78, and 86 ''Traceability for Livestock Moving Interstate'' or the unofficial identification that is unique to the animal on the enrolled premises, as previously described in Subsection 9.j. (related to identification of subject animals) of this General Quarantine Order.
C. The sex, date of birth and species of the subject cervid.
D. The date of departure from the premises of origin of each cervid and the date of arrival at the final premises destination of each cervid. Locations where the cervid(s) were transferred, off loaded, held or otherwise stopped over at a destination that was not the final premises destination, the date of arrival and date of departure of each cervid from that destination.
x. For each cervid or herd of cervids moved, the herd certification status, as set forth in Subsection 9.c. (related to status of herd), of each cervid herd, from which each cervid was purchased, to which each cervid was shipped and the herd certification status of any person, entity or herd at which the cervid or herd of cervids was stopped-over or unloaded. Such information shall include the information for each person or entity as is required by paragraphs vi., vii. and viii. of this Subsection 9.l. (related to ongoing movement of cervids recordkeeping and reporting requirements) of this General Quarantine Order.
A. Where the cervid herd or individual cervid is not from a certified herd, the appropriate status, such as monitored, shall still be set forth. Such information shall include the information for each person or entity as is required by paragraphs vi., vii. and viii. of this Subsection 9.l. (related to ongoing movement of cervids recordkeeping and reporting requirements) of this General Quarantine Order.
B. Where the cervid herd or individual cervid is from an out-of-state herd the certification status assigned to the cervid(s) by the state of origin shall be set forth. Such information shall include the information for each person or entity as is required by paragraphs vi., vii. and viii. of this Subsection 9.l. (related to ongoing movement of cervids recordkeeping and reporting requirements) of this General Quarantine Order.
m. Ongoing Reporting Requirement regarding Theft or Escape of CWD-Susceptible Cervids from an Enrolled Herd or Wild CWD-Susceptible Cervids entering an Enrolled Herd.
i. Theft or escape—A program participant shall report to the designated Department's regional office within 48 hours the removal of any farmed or captive CWD-susceptible cervid from the enrolled herd through theft or escape. The program participant shall file a signed, written report of theft or escape of a cervid with the designated Department's regional office within ten (10) business days of the theft or escape either by mail, fax or email. The signed written report shall set forth the date of such theft or escape, the cause of such escape or perpetrator of such theft if known, a copy of the police report if theft was involved and shall clearly identify each cervid, including setting forth the official identification of each cervid, that escaped or was stolen.
ii. Breach by a wild CWD susceptible cervid—A program participant shall report to the designated regional office within 48 hours if a wild CWD-susceptible cervid or any other CWD-susceptible cervid gains entrance into the enrolled herd. The program participant shall file a signed, written report with the designated Department's regional office within ten (10) business days of the incident. Such report shall be filed either by mail, fax, or email. The signed written report shall set forth the date on which the wild CWD-susceptible cervid or any other CWD-susceptible cervid gained entrance and any action taken by the program participant, including the date on which the wild CWD susceptible cervid or any other CWD-susceptible cervid was removed from the enclosure, the method of removal, the cause of incident, such as a break in the fence or a gate left open and any action taken to prevent the ingress of wild CWD susceptible cervids or any other CWD-susceptible cervid from occurring again.
iii. Exception—This reporting requirement is not applicable to additions to a herd as described in Subsection 9.q. (related to additions to the herd).
iv. Failure to report—Failure to report theft, escapes, or ingress of wild cervids within prescribed deadlines shall be a violation of this General Quarantine Order and may result in imposition of such criminal and civil penalties and remedies as allowed under the Domestic Animal Law (3 Pa.C.S.A. §§ 2380.8, 2383 and 2386) and loss of program enrollment and placement in the Herd Monitoring Program.
n. Whole herd visual or hands-on inventory verification. Whole herd inventories, either on a yearly basis (visual inventory) or every three years (hands-on inventory) as set forth specifically below, shall be required and shall be carried out by an Accredited Category II Veterinarian, at the program participant's expense.
i. Whole herd inventories shall be done by either visual or hands-on verification, as set forth in paragraphs iii. and iv. of this Subsection 9.n. (related to whole herd visual or hands-on inventory verification). Whole herd inventories shall be reported on forms provided by the Department. It shall be the responsibility of the program participant to ensure all such forms are properly completed, signed, and mailed to the Department by the due date established in this General Quarantine Order.
ii. Whole herd inventories shall be required for all certified herd program participants. Whole herd inventories shall be conducted and performed by Accredited Category II veterinarians as set forth in paragraphs iii, iv and v. of this Subsection 9.n. (related to whole herd visual or hands-on inventory verification). Herd Certification Program participants shall have either a whole herd visual herd inventory performed each year, as set forth in paragraph iv. (related to whole herd visual herd inventory verification) of this Subsection 9.n. or a whole herd hands-on inventory verification performed every three years, as set forth in paragraph v. (related to whole herd hands-on inventory verification) of this Subsection 9.n..
iii. Inventory verification required. A visual or hands-on herd inventory by an Accredited Category II veterinarian shall be required for new program participants by the last day of the month comprising the program participant's anniversary date as selected by the new program participant, at the discretion of the Department. Current Herd Certification Program participants shall be required to have a visual or hands-on herd inventory completed by an Accredited Category II veterinarian by the last day of the month comprising the program participant's anniversary date as selected by the owner/program participant. In all cases the owner/program participant shall be responsible for assembling, handling, and restraining the animals and for all costs incurred to complete the visual or hands-on herd inventory. The owner/program participant shall be responsible for resolving any herd inventory discrepancies within a timeframe acceptable to USDA, APHIS, VS and the Department.
iv. Whole herd visual herd inventory verification. Herd inventories shall be visually verified at least every 12 months and shall be due to the Department by the last day of the month comprising the program participant's anniversary date. The whole herd visual herd inventory report shall be sent to the Department's headquarters in Harrisburg, Pennsylvania and may be sent via mail, email or fax. However, additional inventory verifications may be performed at the discretion of the Department. Accredited Category II veterinarians are approved to and shall be utilized to perform annual visual herd inventory verification. Those animals 12 months of age and older shall be bearing approved animal identification ear tags meeting the criteria of Subsection 9.j. (related to identification of subject animals) of this General Quarantine Order of which, at least, one form is visible and legible from a distance, within a pen or other suitable enclosure.
A. Where visual verification of the entire herd inventory is not possible, such as where an animal is not bearing a form of approved animal identification that can be visually inspected, the unidentified animal or animals shall be individually restrained for examination or a hands-on inventory of the entire herd shall be conducted. This process shall be completed in a timeframe acceptable to the Department or USDA APHIS.
B. The owner/program participant shall be responsible for assembling or restraining the herd in a manner that will allow the Accredited Category II veterinarian conducting the inventory to confirm the identification of each animal through inspection of one of the two forms of the Department and USDA, APHIS-approved animal identification meeting the criteria established by Subsection 9.j. (related to identification of subject animals) of this General Quarantine Order. A Department or USDA APHIS employee or agent shall have the authority to require the owner/program participant to assemble and restrain the herd for purposes of inventory verification or other compliance issues.
C. A hands-on inventory may require physical restraint of individual animals in chutes or chemical restraint methods which shall be done by and provided by the owner/program participant.
D. Those animals less than 12 months of age, without any identification shall be counted and listed by number and gender. For example, four buck fawns and three doe fawns born in 2014.
v. Whole herd hands-on inventory verification. A whole herd hands-on inventory verification for all Herd Certification Program participants who do not participate in the whole herd annual visual inventory verification option shall be required and performed at no greater than three year intervals, by the last day of the month comprising the program participant's anniversary date, by a USDA APHIS Category II accredited veterinarian. Such inventory verification reports shall be due to the Department by the last day of the month comprising the program participant's anniversary date in the year in which the hands-on inventory is performed. The whole herd hands-on inventory report shall be sent to the Department's headquarters in Harrisburg, Pennsylvania and may be sent via mail, email or fax. The owner or participant may elect to change the anniversary date for the Herd Certification Program, at the Department's discretion.
A. The owner/program participant shall be responsible for assembling and restraining all the animals in a manner that will allow the Accredited Category II veterinarian conducting the inventory to confirm the identification of such animal through inspection of all forms of the Department and USDA, APHIS-approved animal identification meeting the criteria established by Subsection 9.j. (related to identification of subject animals) of this General Quarantine Order of those animals 12 months of age and older. A Department or USDA APHIS employee or agent shall have the authority to require the owner/program participant to assemble and restrain all animals in the herd for purposes of inventory verification or other compliance issues.
B. Those animals less than 12 months of age, without any identification shall be counted and listed by number and gender. For example, four buck fawns and three doe fawns born in 2014.
C. A hands-on inventory may require physical restraint of individual animals in chutes or chemical restraint methods which shall be done by and provided by the owner/program participant.
vi. Reconciliation of herd inventory. All herd inventories verified through either visual or hands-on verification during inventories conducted by a USDA APHIS Category II accredited veterinarian shall be reconciled with written inventories, including respective official identification, required to be kept by the owner/program participant under Subsections 9.k. (related to ongoing annual recordkeeping requirements) and 9.l. (related to ongoing movement of cervids recordkeeping and reporting requirements) of this General Quarantine Order.
A. The reconciliation of herd inventories done through visual or hands-on verification and the owner/program participant's required written inventory records and reports shall be the duty of the owner/program participant.
B. A discrepancy in herd inventories done through visual or hands-on verification and the owner/program participant's written inventory records and reports shall be prima facie evidence of a violation of the recordkeeping provisions of this General Quarantine Order.
C. If duplicate (non-unique to the animal in the herd) secondary identification is observed during inventories conducted by a USDA APHIS Category II accredited veterinarian that duplication shall be resolved within a time frame acceptable to the Department.
vii. Whole herd inventory noncompliance—Failure to comply with the provisions of this Subsection 9.n. (related to whole herd visual or hands-on inventory verification) shall be a violation of this General Quarantine Order and may result in imposition of such criminal and civil penalties and remedies as allowed under the Domestic Animal Law (3 Pa.C.S.A. §§ 2380.8, 2383 and 2386).
o. Department Inspections. The Department or its agents acting under the authority and direction of the Department will, at least once per calendar year and as many times as may be necessary to assure compliance with this General Quarantine Order or in response to complaints, inspect the premises upon which an enrolled herd of farmed or captive CWD-susceptible cervids is maintained. The Department may conduct additional inspections at reasonable times. Inspections may include records review, herd inventory with individual animal identification (ID), inspecting fences to assure compliance with the height, maintenance and ingress and egress provisions of Subsection 9.p and other measures within the scope of authority of the Department and necessary to determine compliance with the Herd Certification Program and this General Quarantine Order.
i. Independent Inspections. Department inspections are separate and apart from the requirements of Subsection 9.n. (related to whole herd visual or hands-on inventory verification) and shall not be construed to meet the requirements thereof. Department inspections shall not constitute and shall not be done as a substitute for whole herd visual or hands-on inventory verification required by Subsection 9.n. of this General Quarantine Order.
ii. Interference with officer or employee of the department. As established at section 2385 of the Domestic Animal Law (3 Pa.C.S.A. § 2385), a person who willfully or intentionally interferes with an employee or officer of the department in the performance of duties or activities authorized under the Domestic Animal Law, which includes this General Quarantine Order, commits a misdemeanor of the third degree and shall, upon conviction, be subject to a term of imprisonment of not more than one year or a fine of not more than $2,500, or both.
p. Fencing. A herd of farmed or captive CWD-susceptible cervids that is enrolled under the Herd Certification Program shall be maintained so as to prevent ingress and egress of cervids. Fence height shall be a minimum of 8 feet, although a 10-foot height is recommended.
q. Additions to the Herd. The following requirements apply regardless of the period of time the cervid is in the herd (Example: when a buck is moved to an enrolled herd for breeding season). The addition of a CWD-susceptible cervid to a herd enrolled in the Herd Certification Program shall be done in accordance with all of the following requirements:
i. The addition of each cervid shall be documented consistent with and in the manner required by Subsection 9.l. (related to ongoing movement of cervids recordkeeping and reporting requirements) and shall be set forth in the annual report required by Subsection 9.k. (related to ongoing annual recordkeeping requirements) of this General Quarantine Order.
ii. No CWD-susceptible cervid may be added to a herd of farmed or captive CWD-susceptible cervids that is enrolled under the Herd Certification Program unless the CWD-susceptible cervid to be added originates from that herd or a herd that is also enrolled in and in good standing in the Pennsylvania Herd Certification Program.
iii. The added CWD-susceptible cervid shall be from a herd of an equal or greater certification status, as established in Subsection 9.c. (related to status of herd).
iv. Cervids sourced from out-of state herds must originate from fully certified (five year status) herds as required by 9 CFR Part 81 of the Code of Federal Regulations.
v. CWD-susceptible cervids shipped interstate or intrastate shall not be stopped over at or exposed to any cervid operation that does not meet the requirements set forth in this subsection or that is not in compliance with this General Quarantine Order.
A. Where a CWD-susceptible cervid is stopped over or unloaded at another premises on which CWD-susceptible cervids are kept or otherwise exposed to other CWD-susceptible cervids, those CWD-susceptible cervids shall be from a herd of equal certification status.
B. Where the stop over premises maintains CWD-susceptible cervids of a lower certification status, the incoming CWD-susceptible cervid(s) certification status shall be lowered to at least the certification status of the herd maintained on the stop over premises.
C. Where the stop over premises is within the Commonwealth and has a certification status greater than that of the CWD-susceptible species stopped over or unloaded at that premises, the certification status of the CWD-susceptible species maintained at the stop over premises shall be reduced to at least the certification status of the stopped over or incoming CWD-susceptible cervids.
vi. Failure to comply with the intrastate movement requirements shall result in adjustment of the herd certification status of the receiving program participant. The herd certification status shall be reduced to the herd certification status of the incoming cervid(s) or a lower status or the receiving program participant's herd being removed from the voluntary herd certification program and placed in the mandatory herd monitoring program.
vii. Failure to comply with interstate movement requirements shall result in removal from the voluntary Herd Certification Program and placement in the mandatory Herd Monitoring Program.
viii. A violation of any of the provisions of this Subsection 9.q (related to additions to the herd) may also result in the imposition of such criminal and civil penalties and remedies as allowed under the Domestic Animal Law (3 Pa.C.S.A. §§ 2380.8, 2383 and 2386).
r. Usage of semen, embryos, germ plasm, urine, and other cervid by-products. Semen, embryos, germ plasm, urine and other cervid by-products may be used in a herd of farmed or captive CWD-susceptible cervids that is enrolled under the Herd Certification Program if the following are met:
i. The donor animal is from a herd of equal or greater herd status as the destination herd. The source herd shall not have a CWD-positive animal, a CWD-suspect animal or a CWD-exposed animal at time of collection of the cervid by-product. The source herd shall not have CWD identified within the 60 months prior to collection.
ii. Out-of-state donor animals shall meet the same Tuberculosis and Brucellosis testing requirements as would be applicable if the donor animal, itself, was being imported.
iii. Records shall be maintained for 5 years from the date of receipt by the seller and buyer including (as applicable) collection date, animal identification, including the official identification number, with respect to the cervid from which the cervid by-product was collected, animal identification, including the official identification number, with respect to the cervid that received the cervid by-product, date of sale, the CWD status of the source premises, and both buyer and seller name, address and telephone number. If a donor animal is from outside this Commonwealth, records of negative Tuberculosis and Brucellosis testing shall also be maintained. Records shall demonstrate that semen, embryos, urine and other cervid by-products from CWD-positive, CWD-suspect, CWD-exposed, and CWD quarantined herds have been destroyed, including the date and method of destruction.
s. Intrastate Movement of Enrolled Cervids. Farmed or captive CWD-susceptible cervids that are enrolled under the Herd Certification Program may be moved intrastate only if all of the following requirements are fulfilled:
i. The cervid shall only be sold, lent, leased, consigned, exchanged, bartered, gifted, boarded, moved including for breeding purposes, given, harvested or otherwise transferred to a person or entity that is currently enrolled in either the CWD herd certification or CWD herd monitoring program established by this General Quarantine Order.
ii. The identification requirements delineated in Subsection 9.j. (related to identification of subject animals) of this General Quarantine Order are followed and obeyed.
iii. The movement is properly and fully recorded in a manner that meets all of the requirements established under Subsection 9.k. (related to ongoing annual recordkeeping requirements) of this General Quarantine Order.
iv. The movement is properly and fully recorded in a manner that meets all of the requirements established under Subsection 9.l. (related to ongoing movement of cervids recordkeeping and reporting requirements) of this General Quarantine Order.
v. The herd addition requirements established under Subsection 9.q. (related to additions to the herd) of this General Quarantine Order are followed and obeyed.
vi. A cervid enrolled under the Certified Herd Program shall not be moved back onto a certified herd property, if that cervid has entered onto the premises of a monitored herd or a non-enrolled premises, such as a stop-over premises or a fairground, even if such movement was for display purposes only.
vii. All other applicable intrastate movement requirements established by the Domestic Animal Law, its attendant regulations or an order of the Department are followed and obeyed.
t. Bills of Sale. All program participants shall create and have in their possession and shall keep as a part of their records for a period of five (5) years a bill of sale for each cervid purchased or sold. The bill of sale shall have information necessary to comply with the recordkeeping provisions of Subsection 9.l.vi., vii., viii. ix. and x. (related to ongoing movement of cervids recordkeeping and reporting requirements). For each cervid transferred by a means other than sale, including barter, lease, loan, exchange or otherwise, a written document of the transaction setting forth the type of transfer and the information required in the Bill of Sale shall be created. Such document shall be maintained as a part of the program participants file for a period of five (5) years. All documents required by this subsection shall be made available to the Department, its employees or agents, upon request.
u. Changes of Status or Change of Program for Non-Compliance. If a herd is enrolled in the CWD Herd Certification Program, and the program participant fails to meet the applicable requirements of the voluntary Herd Certification Program as described in this General Quarantine Order or the enrolled herd is not maintained in accordance with the applicable requirements of this General Quarantine Order, the Department may, as it determines is appropriate and for reasons more specifically set forth in the Herd Certification Program provisions of this General Quarantine Order, change the herd certification status of the enrolled herd to a lower status, or remove the herd from the voluntary CWD Herd Certification Program and enroll it under the mandatory CWD Herd Monitoring Program. These actions may be taken for violations such as failure to meet applicable mandatory testing requirements, animal identification requirements, reporting requirements, recordkeeping requirements, herd addition requirements, interstate or intrastate movement requirements or any other requirements imposed by this General Quarantine Order. Herd Certification Program participants found in violation of this Order shall be subject to imposition of such criminal and civil penalties and remedies as allowed under the Domestic Animal Law (3 Pa.C.S.A. §§ 2380.8, 2383 and 2386).
10. CWD Herd Monitoring Program.
a. Program established. The Chronic Wasting Disease Herd Monitoring Program (Herd Monitoring Program) as established by the August 4, 2006, General Quarantine Order; Chronic Wasting Disease Program (36 Pa.B. 4612 (August 19, 2006) described in Section 2 (related to October 19, 2013 and February 4, 2011 general quarantine order; chronic wasting disease program) and continued by the February 4, 2011, General Quarantine Order; Chronic Wasting Disease Program (41 Pa.B. 727 (February 5, 2011)), as the Chronic Wasting Disease Herd Monitoring Program (Herd Monitoring Program), is continued as otherwise modified by this Order in the manner established herein.
b. Mandatory Program. Enrollment in the CWD Herd Monitoring Program is mandatory, if not participating in the voluntary CWD Herd Certification Program, for those that own CWD-susceptible species. The CWD Herd Monitoring Program establishes criteria which are less stringent than those required by the CWD Herd Certification Program. Failure to enroll in the mandatory CWD Herd Monitoring Program or failure to comply with the criteria established in this General Quarantine Order may result in the imposition of penalties, such as criminal and civil penalties, injunctive, civil and equitable relief, as is allowed under the Domestic Animal Law (3 Pa.C.S.A. § 2301 et seq.).
c. Previously Enrolled Herds. The status of herds enrolled in the CWD Herd Monitoring Program under the February 4, 2011 Order of General Quarantine which are in compliance with that Order as of the effective date of this General Quarantine Order will maintain their existing status under this Order of General Quarantine if they elect to enroll in and agree to comply with the provisions of the CWD Herd Monitoring Program established under this Order of General Quarantine.
d. Duty to Report Suspects and Dead Cervids and Dead Cervids found in an advanced state of decomposition. The program participant, the owner of a herd of farmed or captive CWD-susceptible cervids and any caretaker of that herd shall report any suspect cervid, dead cervid or dead cervid found in an advanced state of decomposition as set forth herein. Failure to comply with any of the provisions of this subsection including failure to report a suspect cervid, the death of a cervid within the time periods set forth herein or the discarding, removal or disposal of carcasses, parts, offal or tissues in a manner which is inconsistent with the provisions of this subsection or without the required verifications shall constitute a violation of this General Quarantine Order.
i. Suspect Cervid—Any cervid that shows signs that are consistent with CWD (such as staggering, drooling, wasting or unusual behavior) shall be immediately reported to the designated regional office of the Bureau of Animal Health in the Pennsylvania Department of Agriculture. The suspect cervid shall not be removed from the premises of the program participant until such time as the Department has been able to assess the animal and issue an order or guidance with regard to the holding, harvesting, testing and removal of such animal. Failure to immediately report a suspect cervid or abide by the removal provisions of this section shall constitute a violation of this General Quarantine Order.
ii. Dead Cervid—Upon the discovery of any dead farmed or captive CWD-susceptible cervid aged 12 months or older, the program participant, owner or caretaker shall take the following steps and comport with the following protocols:
A. Record the death and include the animal as part of the Ongoing Annual Recordkeeping Requirements, established by Subsection 10.k. of this Order of General Quarantine.
B. Have the dead cervid tested. The entire carcass, head or tissue samples from the carcass shall be transported for testing in accordance with the requirements of Subsections 10.f. (related to mandatory testing for farmed or captive CWD-susceptible cervids designated as CWD suspects) or 10.g. (related to testing protocol for other farmed or captive CWD-susceptible cervids), as applicable, of this General Quarantine Order.
iii. Dead cervid found in an advanced state of decomposition—Upon the discovery of any dead farmed or captive CWD-susceptible cervid aged 12 months or older in an advanced state of decomposition, the program participant, owner or caretaker shall report this death to the designated regional office of the Department within 48 hours. The program participant, owner or caretaker shall take the following steps and comport with the following protocols:
A. The dead cervid, including all parts and offal, shall not be removed from the premises of the program participant, except that the entire carcass or head of the carcass may be transported for testing as set forth in Subsection 10.f.i. (related to mandatory testing for farmed or captive CWD-susceptible cervids designated as CWD suspects) of this General Quarantine Order or tissue samples may be collected and sent for testing as set forth at Subsection 10.f.ii. of this General Quarantine Order.
B. Where only the head or tissue samples are sent for testing, the carcass, parts and offal of the dead cervid shall not be removed from the premises of the program participant until test results have been received or a determination that the carcass is untestable and shall only be disposed of in a manner approved by and set forth in writing by the Department.
C. Dead cervid carcasses considered to be untestable by the program participant or owner shall be verified as such by a Department or USDA, APHIS representative prior to removal or disposal of such carcass, parts and offal. The Department or USDA, APHIS representative may determine that the entire carcass shall be collected and moved directly to a laboratory for collection and potential testing.
iv. Failure to abide by the requirements of this Subsection d. (related to duty to report suspects and dead cervids and dead cervids found in an advanced state of decomposition) shall be a violation of this General Quarantine Order and may result in the imposition of such criminal and civil penalties and remedies as allowed under the Domestic Animal Law (3 Pa.C.S.A. §§ 2380.8, 2383 and 2386).
e. Mandatory Testing. One-hundred percent of all mortalities, due to any cause, shall be tested. The mandatory testing requirements established herein shall become effective upon enrollment and shall apply to all cervids regardless of the herd of origin. A program participant with a herd that is enrolled in the Herd Monitoring Program shall be responsible to ensure that a farmed or captive CWD-susceptible cervid is tested in accordance with Subsections 10.f. (related to mandatory testing for farmed or captive CWD-susceptible cervids designated as CWD suspects) or 10.g. (related to testing protocol for other farmed or captive CWD-susceptible cervids), as applicable, if any of the following occur:
i. The cervid shows signs (such as staggering, drooling, wasting or unusual behavior) that are consistent with CWD and the cervid dies or is killed.
ii. The cervid is 12 months of age or older and is sent to a slaughter facility.
iii. The cervid is 12 months of age or older and dies for any reason (including accident, natural causes, slaughter, harvesting, hunting, culling or any other cause).
f. Mandatory Testing for Farmed or Captive CWD-Susceptible Cervids designated as CWD Suspects. If a dead farmed or captive CWD-susceptible cervid is required to be tested because it showed signs (such as staggering, drooling, wasting, or unusual behavior) that are consistent with CWD before it died or was killed, as described in Subsection 10.e.i. (related to mandatory testing), it shall be tested according to either of the following procedures:
i. A person shall immediately notify the Department of the dead CWD-susceptible cervid and do the following:
A. Collect either the entire carcass of the cervid or the entire head of the cervid with official identification devices attached in situ.
B. Deliver the carcass or head with official identification devices attached in situ for CWD testing. The properly completed chain of custody forms and sample submission forms required under Subsection 10.i. (related to chain of custody of samples; submission of samples) of this General Quarantine Order shall accompany the carcass or head. The carcass or head shall bear a proper form of identification and be delivered within 72 hours of the cervid's death to either a Department laboratory, or to a laboratory that has been approved, in advance, by the Department or USDA, or both, to perform CWD testing. Results of samples submitted without the proper and required official identification or the properly completed chain of custody forms and sample submission forms may not be recognized by the Department and shall be considered a violation of this General Quarantine Order. Any such violation may result in the imposition of such criminal and civil penalties and remedies as allowed under the Domestic Animal Law (3 Pa.C.S.A. §§ 2380.8, 2383 and 2386).
ii. As an alternative to the CWD testing procedure described in paragraph (i), the following procedure shall be followed:
A. Tissue samples shall be collected by one of the following:
I. A USDA, APHIS Category II accredited practitioner of veterinary medicine.
II. An authorized State official. A Department-certified CWD Sampling Technician does not meet the requirements of this subparagraph.
III. An authorized Federal official.
B. Tissue samples shall be collected and preserved within 72 hours of the cervid's death.
C. Tissues samples shall consist of the obex and the medial retropharyngeal lymph nodes preserved in formalin; and in a separate container that does not contain formalin or any other preservative, a small portion of the ear or other skin that is attached to the official identification of the subject cervid.
D. The tissue samples shall be delivered within 72 hours of the cervid's death to the Pennsylvania Veterinary Laboratory or to a laboratory that has been approved in advance by the Department or USDA, or both, for CWD testing. It is the owner's responsibility to report the death within the a time frame that allows for collection and preservation of the tissue samples within 72 hours of the cervid's death as required by Subsection B. above and protect the carcass from further degradation until tissue samples can be collected.
E. Properly completed chain of custody forms and Sample Submission Forms as required under Subsection 10.i. (related to chain of custody of samples: submission of samples) of the General Quarantine Order shall accompany the tissue samples.
g. Testing Protocol for Other Farmed or Captive CWD-Susceptible Cervids. One-hundred percent of all mortalities, due to any cause, shall be tested. If a farmed or captive CWD-susceptible cervid does not exhibit signs (as described in Subsection 10.d.i. (related to duty to report suspects and dead cervids and dead cervids found in an advanced state of decomposition)) that are consistent with CWD, and is required to be tested because it is 12 months of age or older and was either sent to a slaughter facility or died for any reason, as described in Subsections 10.e.ii. and 10.e.iii. (related to mandatory testing), the Department shall be notified by the program participant, who shall send the Department records setting forth the official identification of each farmed or captive CWD-susceptible cervid that was sent to slaughter or died for any reason set forth in Subsection 10.e.ii. and 10.e.iii., along with the name and address of the slaughter facility where each animal was slaughtered or the name and address of the place where the animal died or was harvested and the cause of death (see Subsection10.k. (related to ongoing annual recordkeeping requirements)). In such cases, each farmed or captive CWD-susceptible cervid shall be tested according to the following procedures:
i. Tissue samples shall be collected by one of the following:
A. A USDA, APHIS Category II accredited practitioner of veterinary medicine.
B. An authorized State official.
C. An authorized Federal official.
D. A Department-certified CWD Sampling Technician.
ii. Tissue samples shall be collected and preserved within 72 hours of the cervid's death.
iii. Tissues samples shall consist of the obex and the medial retropharyngeal lymph nodes preserved in formalin; and in a separate container that does not contain formalin or any other preservative, a small portion of the ear or other skin that is attached to the official identification of the subject cervid.
iv. Properly completed chain of custody forms and sample submission forms as required under Section 10.i. (related to chain of custody samples; submission of samples) of this General Quarantine Order shall accompany the tissue samples.
v. The tissue samples shall, within 30 days of collection, be delivered to the Pennsylvania Veterinary Laboratory or a laboratory that has been approved in advance by the Department or USDA, or both, to perform CWD testing.
vi. As an alternative to the testing protocol described in paragraph, i., ii., iii., iv., and v. of this Subsection 10.g. (related to testing protocol for other farmed or captive CWD-susceptible cervids) the following protocols shall be followed:
A. Within 72 hours of the cervid's death, collect and deliver either the entire carcass of the cervid with official identification devices attached in situ or the entire head of the cervid with official identification devices attached in situ to a Department laboratory for CWD testing, or to a laboratory that has been approved in advance by the Department or USDA, or both, to perform CWD testing.
B. The program participant/herd owner shall be responsible for properly identifying the cervid carcass or head and delivering it in a manner that does not destroy or make the animal untestable.
C. The person who delivers the carcass or head need not be an approved tissue collector as described in Subsection 10.g.i. (related to testing protocol for other farmed or captive CWD-susceptible cervids).
D. The name. address, and signature of the person collecting, or the person in possession of the carcass, and the person delivering the carcass or head shall be set forth in writing and such writing shall be attached to the chain of custody forms and sample submission forms required by this General Quarantine Order.
E. The properly completed chain of custody forms and sample submission forms required under Subsection 10.i. (related to chain of custody of samples; submission of samples) of this General Quarantine Order shall accompany the carcass or head.
F. Results of samples submitted without the proper and required official identification or the properly completed chain of custody forms and sample submission forms may not be recognized by the Department and shall be considered a violation of this General Quarantine Order. Any such violation may result in the imposition of such criminal and civil penalties and remedies as allowed under the Domestic Animal Law (3 Pa.C.S.A. §§ 2380.8, 2383 and 2386).
h. Impact of Late Notice, Delivery or Untestable Samples.
i. It is the program participant/herd owner's responsibility to assure good quality tissue is submitted for testing and ensure that all required samples are collected properly and in a timely manner as required by Sections 10.f. (related to mandatory testing for farmed or captive CWD-susceptible cervids designated as CWD suspects) and 10.g. (related to testing protocol for other farmed or captive CWD susceptible cervids) of this General Quarantine Order. All required tissues shall be collected regardless of sample condition (e.g. autolyzed or frozen). In cases where sample quality is poor, the Department shall be notified and a determination made on samples to be submitted.
ii. Failure to abide by the requirements of this section shall be a violation of this General Quarantine Order and may result in the imposition of such criminal and civil penalties and remedies as allowed under the Domestic Animal Law (3 Pa.C.S.A. §§ 2380.8, 2383 and 2386). Where the history of sample collections and submissions from the program participant/herd owner demonstrates a pattern of lack of submission of required samples, untimely submission of samples or poor performance including incorrect tissues submitted, poor tissue quality or non-compliance with the provisions and requirements of Subsections 10.e. (related to mandatory testing), 10.f. (related to mandatory testing for farmed or captive CWD-susceptible cervids designated as CWD suspects) and 10.g. (related to testing protocol for other farmed or captive CWD susceptible cervids) of this General Quarantine Order, the Department may seek such additional remedies, including injunctive relief as is allowed under the Domestic Animal Law. Adherence to the 72-hour deadlines established in this Subsection 10.f.i.B., 10.f.ii.B., 10.f.ii.D. (related to mandatory testing for farmed or captive CWD-susceptible cervids designated as CWD suspects) and 10.g.ii. and 10.g.vi.A. (related to testing protocol for other farmed or captive CWD susceptible cervids) will be considered a mitigating factor by the Department in any penalty assessed.
i. Chain of Custody of Samples; Submission of Samples. A person may obtain chain of custody forms and sample submission forms from the Department by sub-mitting a written request for such forms or by downloading the forms from the Department's website (www.agriculture.state.pa.us).
i. A person submitting a sample (whether tissue samples, an entire carcass or an entire head) for testing under the Herd Monitoring Program shall complete a chain of custody form and a sample submission form, and shall submit those forms along with the sample that is delivered for testing.
ii. The chain of custody form shall clearly identify the premises, including the address of the premises and the name and signature of the herd owner, on which the cervid resided and from which it was taken, official identification on the cervid, the date of sampling, and the persons (in chronological order) who handled the sample from the point it was taken until it is delivered to the Pennsylvania Veterinary Laboratory or a Department-approved laboratory, or a USDA-approved laboratory for CWD testing.
iii. The chain of custody form shall bear the signature, printed name and other identifying information with respect to each person who handles the sample.
iv. The completed chain of custody form and the sample submission form shall be provided to a responsible person at the laboratory to which the sample is delivered.
j. Identification of Subject Animals. Each farmed or captive CWD-susceptible cervid that is within a herd enrolled in the Herd Monitoring Program shall have at least one form of the Department and/or USDA, APHIS-approved official animal identification attached if it is transported from the enrolled premises or is tested for CWD as required by Subsection 10.e. (related to mandatory testing) of this General Quarantine Order. In accordance with 9 CFR Parts 71, 77, 78, and 86 ''Traceability for Livestock Moving Interstate'', official identification shall not be removed from animals. Identification devices shall be submitted with tissues or remain in place when heads or carcasses are submitted for testing. Forms of identification that are Department-approved or USDA, APHIS-approved, or both, are considered ''official'' forms of identification for purposes of this provision and include the following:
i. A legible and unique tattoo approved by the Department or USDA, APHIS.
ii. A USDA, APHIS-issued ear tag, bearing a unique number provided by USDA, APHIS that utilizes one of the following numbering systems:
A. The National Uniform Eartagging System (NUES).
B. The Animal Identification Number (AIN) bearing 15 digits starting with '840.'
C. The premises-based numbering system using a Premises Identification Number (PIN) in conjunction with a livestock production numbering system.
D. Any other numbering system approved by USDA, APHIS and the state veterinarian.
iii. A Department-issued metal ear tag, bearing a unique number provided by the Department.
iv. An electronic implant device, such as a microchip, that utilizes a nationally unique 15 digit animal identification number starting with '840' provided an appropriate reader is immediately available wherever the animal is located.
v. Any other identification device approved by the Department and USDA, APHIS.
k. Ongoing Annual Recordkeeping Requirements. A program participant with a herd that is enrolled in the Herd Monitoring Program shall maintain up-to-date herd inventory records with respect to the subject herd for a period of 5 years, shall make these records available for inspection by the Department upon request, and shall mail or deliver a copy of these records to the Department no later than one month after each anniversary of the ''date of enrollment'' in the Herd Monitoring Program. These records shall be kept and filed on forms developed, approved and provided by the Department. The forms will be made available on the Department's website (www.agriculture.state.pa.us) and will be available in paper form for those program participants that do not have internet access. The program participant shall be required to complete all fields on the recordkeeping forms and incomplete forms shall be returned to the program participant with a deadline for completion. These records shall include the following information with respect to each subject cervid:
i. Herd size (estimate if exact size is not known).
ii. Documentation of test results indicating a testing level of no less than 100% of cervids that have died from any cause, or were slaughtered or harvested from the last provided inventory and in accordance with the recordkeeping provisions, Subsections 10.k and 10.l. of this General Quarantine Order.
iii. For each CWD-susceptible cervid with identification that is enrolled in the Herd Monitoring Program:
A. The unique number or identification information from the tattoo, tag, electronic implant device or other identification device described in Subsection 10.j. (related to identification of subject animals).
B. The sex and species of the subject cervid.
C. The date of birth of the subject cervid.
iv. The date of departure and the destination of any subject cervid removed from the herd since the last provided inventory. Such records shall include all of the following information:
A. The contact information (name, complete address, telephone number and when available, email address) of the person to whom the cervid was sold, lent, leased, consigned, exchanged, bartered, gifted, boarded, moved including for breeding purposes, given, harvested or otherwise transferred.
B. The contact information (name, complete address, telephone number and where applicable, Pennsylvania Dealer/Hauler or Cervidae Livestock Operations license number or both where both types of licenses are held) of any dealer, hauler or broker or Pennsylvania cervid livestock operation utilized in such transaction.
C. The date of death and cause of death (if known) of any subject cervid that dies and the CWD test result for that animal.
v. If the subject cervid is new to the herd since the ''date of enrollment,'' or previous annual inventory report, designation of whether the subject was born to the herd or acquired from outside the herd. If the subject cervid was acquired from outside the herd the following information shall be provided:
A. The source of the subject cervid including contact information (name, complete address, telephone number and when available, email address) of the source herd.
B. The date of acquisition.
vi. Where a Pennsylvania dealer, hauler, broker or Pennsylvania cervid livestock operation was involved in the transaction, the name, complete address, telephone number and Pennsylvania Dealer/Hauler or Cervidae Livestock Operations license number or both where both types of licenses are held of such dealer, hauler, broker or Pennsylvania cervid livestock operation.
l. Ongoing Movement of Cervids Recordkeeping and Reporting Requirements. A program participant shall report any and all movements of CWD susceptible species of cervids onto and off of the premises (i.e. additions and deletions to the herd) if the transaction was with a Herd Certification Program participating herd. Such reports shall meet the requirements of Subsection 9.l. (related to CWD Herd Certification Program, ongoing movement of cervids recordkeeping and reporting requirements).
m. Ongoing Reporting Requirement regarding Theft or Escape of CWD-Susceptible Cervids from an Enrolled Herd or Wild CWD-Susceptible Cervids entering an Enrolled Herd.
i. Theft or escape—A program participant shall report to the designated Department's regional office within 48 hours the removal of any farmed or captive CWD-susceptible cervid from the enrolled herd through theft or escape. The program participant shall file a signed, written report of theft or escape of a cervid with the designated Department's regional office within ten (10) business days of the theft or escape either by mail, fax or email. The signed written report shall set forth the date of such theft or escape, the cause of such escape or perpetrator of such theft if known, a copy of the police report if theft was involved and shall clearly identify each cervid, including setting forth the official identification of each cervid, that escaped or was stolen.
ii. Breach by a wild CWD susceptible cervid—A program participant shall report to the designated regional office within 48 hours if a wild CWD-susceptible cervid or any other CWD-susceptible cervid gains entrance into the enrolled herd. The program participant shall file a signed, written report with the designated Department's regional office within ten (10) business days of the incident. Such report shall be filed either by mail, fax or email. The signed written report shall set forth the date on which the wild CWD-susceptible cervid or any other CWD-susceptible cervid gained entrance and any action taken by the program participant, including the date on which the wild CWD susceptible cervid or any other CWD susceptible cervid was removed from the enclosure, the method of removal, the cause of incident, such as break in the fence or a gate left open and any action taken to prevent the ingress of wild CWD susceptible cervids or any other CWD susceptible cervid from occurring again.
iii. Exception—This reporting requirement is not applicable to additions to a herd as described in Subsection 10.p. (related to additions to the herd)
iv. Failure to report—Failure to report theft, escapes, or ingress of wild cervids within prescribed deadlines shall be a violation of this General Quarantine Order and may result in imposition of such criminal and civil penalties and remedies as allowed under the Domestic Animal Law (3 Pa.C.S.A. §§ 2380.8, 2383 and 2386).
n. Inspections. The Department or agents acting under authority and direction of the Department may, at its discretion, inspect the premises upon which an enrolled herd of farmed or captive CWD-susceptible cervids is maintained to assure compliance with this General Quarantine Order or in response to complaints. The Department may conduct additional inspections at reasonable times.
i. General scope—Inspections may include records review, checking individual animal identification, whole herd inventory with individual animal identification, inspecting fences to assure compliance with the height, maintenance and ingress and egress provisions of Subsection 10.o. and other measures within the scope of authority of the Department and necessary to determine compliance with the Herd Monitoring Program. A program participant shall cooperate with the Department, and shall facilitate the inspection by making premises, animals and records available to the Department without delay.
ii. Inspection noncompliance—Failure to comply shall be a violation of this General Quarantine Order and may result in imposition of such criminal and civil penalties and remedies as allowed under the Domestic Animal Law (3 Pa.C.S.A. §§ 2380.8, 2383 and 2386).
iii. Interference with officer or employee of the department. As established at section 2385 of the Domestic Animal Law (3 Pa.C.S.A. § 2385), a person who willfully or intentionally interferes with an employee or officer of the department in the performance of duties or activities authorized under the Domestic Animal Law, which includes this General Quarantine Order, commits a misdemeanor of the third degree and shall, upon conviction, be subject to a term of imprisonment of not more than one year or a fine of not more than $2,500, or both.
o. Fencing. A herd of farmed or captive CWD-susceptible cervids that is enrolled under the Herd Monitoring Program shall be maintained so as to prevent ingress and egress of cervids. Fence height is to be a minimum of 8 feet, although a 10-foot minimum height is recommended.
p. Additions to the Herd. The following requirements apply regardless of the period of time the cervid is in the herd (Example: when a buck is moved to an enrolled herd for breeding season). The addition of a CWD susceptible cervid to a herd enrolled in the Herd Monitoring Program shall be done in accordance with all of the following requirements:
i. The addition of each cervid shall be documented consistent with and in the manner required by Subsection 10.l. (related to ongoing movement of cervids recordkeeping and reporting requirements) and shall be set forth in the annual report required by Subsection 10.k. (related to ongoing annual recordkeeping requirements) of this General Quarantine Order.
ii. Cervids sourced from out-of-state herds must originate from fully certified herds as required by 9 CFR Part 81 of the Code of Federal Regulations.
iii. A violation of any of the provisions of this Subsection 10.p. (related to additions to the herd) may result in the imposition of such criminal and civil penalties and remedies as allowed under the Domestic Animal Law (3 Pa.C.S.A. §§ 2380.8, 2383 and 2386).
q. Usage of semen, embryos, germ plasm, urine, and other cervid by-products. Semen, embryos, germ plasm, urine and other cervid by-products may be used in a herd of farmed or captive CWD-susceptible cervids that is enrolled under the Herd Monitoring Program if the following are met:
i. The donor animal is from a herd enrolled in the CWD Herd Monitoring Program, CWD Herd Certification Program, or an equivalent USDA, APHIS-approved out-of-state Herd Certification Program. The source herd shall not have a CWD-positive animal, CWD-suspect animal, or CWD-exposed animal at time of collection of the cervid by-product. The source herd shall not have CWD identified within the 60 months prior to collection.
ii. Out-of-state donor animals shall meet the same Tuberculosis and Brucellosis testing requirements as would be applicable if the donor animal, itself, was being imported.
iii. Records shall be maintained for 5 years from the date of receipt by the seller and buyer including (as applicable) collection date, animal identification including the official identification if available, with respect to the cervid from which the cervid by-product was collected, animal identification including the official identification if available, with respect to the cervid that received the cervid by-product, date of sale, the CWD status of the source premises, and both buyer and seller name, address and telephone number. If a donor animal is from outside the Commonwealth, records of negative Tuberculosis and Brucellosis testing shall also be maintained. Records shall demonstrate that semen, embryos, urine and other cervid by-products from CWD-positive, CWD-suspect, CWD-exposed and CWD-quarantined herds have been destroyed, including the date and method of destruction.
r. Limitations on Intrastate Movement of Enrolled Cervids. Farmed or captive CWD-susceptible cervids that are enrolled under the Herd Monitoring Program may be transported intrastate to destinations including hunting preserves, slaughter facilities, other Herd Monitoring Program participating herds or new premises obtaining cervids for the first time; only if all of the following requirements are fulfilled:
i. The cervid shall only be sold, lent, leased, consigned, exchanged, bartered, gifted, boarded, moved including for breeding purposes, given, harvested or otherwise transferred to a person or entity that is currently enrolled in either the Herd Certification Program or the Herd Monitoring Program established by this General Quarantine Order.
ii. The identification requirements delineated in Subsection 10.j. (related to identification of subject animals) of this General Quarantine Order are followed and obeyed.
iii. The movement is properly and fully recorded in a manner that meets all of the requirements established under Subsection 10.k. (related to ongoing annual recordkeeping requirements) of this General Quarantine Order.
iv. The movement is properly and fully recorded in a manner that meets all of the requirements established under Subsection 10.l. (related to ongoing movement of cervids recordkeeping and reporting requirements) of this General Quarantine Order.
v. The herd addition requirements established under Subsection 10.p. (related to additions to the herd) of this General Quarantine Order are followed and obeyed.
vi. All other applicable intrastate movement requirements established by the Domestic Animal Law, its attendant regulations or an order of the Department are followed and obeyed.
s. Bills of Sale. All program participants shall create and have in their possession and shall keep as a part of their records for a period of five (5) years a bill of sale for each cervid purchased or sold. The bill of sale shall have information necessary to comply with the recordkeeping provisions of Subsection 9.l. (related to CWD herd certification program, ongoing movement of cervids recordkeeping and reporting requirements). For each cervid transferred by a means other than sale, including barter, lease, loan, exchange or otherwise, a written document of the transaction setting forth the type of transfer and the information required in the Bill of Sale shall be created. Such document shall be maintained as a part of the program participants file for a period of five (5) years. All documents required by this subsection shall be made available to the Department, its employees or agents, upon request.
t. Noncompliance. If a herd is enrolled in the mandatory CWD Herd Monitoring Program, and the program participant fails to meet the applicable requirements of this Order or the enrolled herd is not maintained in accordance with the applicable requirements of this Order, the Department may, as it determines is appropriate, take enforcement action. This action may be taken for violations such as failure to meet applicable mandatory testing requirements, animal identification requirements, reporting requirements, recordkeeping requirements or any other requirements imposed by this Order. Herd Monitoring Program participants found in violation of this Order shall be subject to imposition of such criminal and civil penalties and remedies as allowed under the Domestic Animal Law (3 Pa.C.S.A. §§ 2380.8, 2383 and 2386).
11. Participation of non CWD-susceptible cervids in the Herd Certification Program or Herd Monitoring Program. Any contrary provision of this Order notwithstanding, persons may voluntarily enroll farmed or captive cervids that are not CWD-susceptible cervids (example: reindeer) in either the Herd Certification Program or the Herd Monitoring Program. Voluntary enrollment shall subject the owner/program participant to all provisions of the Program in which they enroll and the owner/program participant shall be required to meet and comply with all of the standard and edicts of either Program including those requirements that are specifically stated for CWD susceptible species.
12. Violations/Penalties. Any person violating the requirements of this Order shall be subject to imposition of such criminal and civil penalties and remedies as allowed under the Domestic Animal Law (3 Pa.C.S.A. §§ 2380.8, 2383 and 2386).
13. No Restriction on Further Action by the Department. This Order shall not be construed as limiting the Department's authority to establish additional quarantine or testing requirements on imported cervids.
14. Effective Date. Sections A though L of the ''Recitals'' and Sections 2. through 8. and 12. through 14. of this ''Order of General Quarantine'' shall become effective immediately upon publication in the Pennsylvania Bulle-tin. This Order in its entirety shall become effective as of August 1, 2014 and shall remain in effect unless rescinded or modified by subsequent order.
GEORGE D. GREIG,
Secretary
[Pa.B. Doc. No. 14-377. Filed for public inspection February 21, 2014, 9:00 a.m.]
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