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DEPARTMENT OF AGRICULTURE

General Quarantine Order; Chronic Wasting Disease Program Requirements

[41 Pa.B. 727]
[Saturday, February 5, 2011]

Recitals

 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, and no successful vaccine against 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 could 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 may result in the destruction of the entire herd and may severely limit the market for product in this Commonwealth.

 H. Although CWD has not, to date, been detected in this Commonwealth, it has been detected in cervids in 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. This 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. By this Order, the Department is rescinding and supplanting the referenced August 4, 2006, General Quarantine Order to reflect the experience the Department has gained in administering the referenced general quarantine, as well as its current understanding of the threat posed by CWD.

Order of Quarantine

 With the foregoing recitals incorporated into this 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 Order are as follows:

 1. Quarantine Area. This General Quarantine is applicable to the entire Commonwealth of Pennsylvania.

 2. August 4, 2006 General Quarantine Order. The August 4, 2006 General Quarantine Order, published at 36 Pa.B. 4612 (August 19, 2006), is hereby rescinded and supplanted by this General Quarantine Order. Persons, premises and animals that were enrolled in either the CWD Herd Certification Program or the CWD Herd Monitoring Program under authority of the August 4, 2006 General Quarantine Order shall remain enrolled under the authority of this Order, and shall be subject to the terms and requirements of this Order. Persons currently enrolled under either of these Programs shall be afforded up to 60 days from the date of this Order within which to come into compliance with any new or different requirements imposed by this Order.

 3. Program Enrollment Requirement. 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 hybrid thereof, in captivity within this Commonwealth shall provide the Department with a completed Program Enrollment Form, as described in Section 5. The requirements of this Order are applicable to any type of location or operation at which CWD-susceptible cervids are maintained, including (but not limited to) private residences, farms, hunting ranches, zoological displays and menageries.

 4. Meeting the Program Enrollment Requirement; Required Adherence to Herd Certification or Herd Monitored Protocols. Farmed or captive CWD-susceptible cervids as described in Section 3 present on each premises described in Section 3 shall be enrolled by the cervid owner in either the CWD Herd Certification Program or the CWD Herd Monitored Program (both of which are described as follows). A cervid owner that is required to enroll one or more CWD-susceptible cervids under this Order, and who enrolls the animals in either the CWD Herd Certification Program or the CWD Herd Monitored Program, shall be referred to as a ''program participant'' throughout this 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.

 5. Obtaining a Program Enrollment Form. The Program Enrollment Forms described in Section 4 (for either the CWD Herd Certification Program or the CWD Herd Monitored 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 Coordinator
2301 North Cameron Street
Harrisburg, PA 17110-9408

 c. Downloading the forms from the Department's web site (www.agriculture.state.pa.us).

 6. Contents of the Program Enrollment Form for the CWD Herd Certification Program. The Program Enrollment Form for the CWD Herd Certification Program shall require the following information:

 a. Name, address, telephone number and e-mail address of the person who owns each subject farmed or captive cervid.

 b. Name, address, telephone number and e-mail address of the person who maintains each subject cervid, if other than the owner.

 c. Mailing address of premises at which each subject cervid is maintained in captivity or driving directions to the premises if there is no mailing address where each subject cervid is maintained.

 d. Number of cervids maintained on the premises, by species.

 e. The official identification (as described in Section 9(i)), farm identification, sex and date of birth of each subject cervid.

 f. The date of acquisition and source of each subject cervid that was not born into the herd.

 g. The location at which the records required under the Herd Certification Program shall be maintained and made available for inspection by the Department.

 7. Contents of the Program Enrollment Form for the CWD Herd Monitored Program. The Program Enrollment Form for the CWD Herd Monitored Program shall require the following information:

 a. Name, address, telephone number and e-mail address of the person who owns each subject farmed or captive cervid.

 b. Name, address, telephone number and e-mail address of the person who maintains each subject cervid, if that person is other than the owner.

 c. Mailing address of premises at which each cervid is maintained in captivity, or driving directions to the premises if there is no mailing address where each cervid is maintained.

 d. 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.

 e. The date of acquisition and source of each subject cervid that was not born into the herd.

 f. The location at which the records required under the Herd Monitored 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 Order shall deliver the completed Form to the Department by faxing it to (717) 787-1868, or mailing or delivering it to the address set forth in Section 5(b).

 9. CWD Herd Certification Program.

 a. Program established. The Chronic Wasting Disease Herd Certification Program (Herd Certification Program), as established by the August 4, 2006, General Quarantine Order described in Section 2, is continued, as modified by this Order.

 b. 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 ''Certified Status.'' the Department shall note 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 ''First Year Status'' for the first year following that date of enrollment. On the first four enrollment anniversary dates following enrollment, and if all of the applicable requirements of this Order have been met, the status of the herd shall be upgraded by 1 year. On the fifth enrollment anniversary date (that is, after 5 consecutive years of program participation have been completed), the status of the herd shall be upgraded to ''Certified Status'' if all of the conditions of the Herd Certification Program have been complied with, and this status shall last as long as the herd is CWD-free and continues to meet Herd Certification Program standards. If the herd is withdrawn from the Herd Certification Program and subsequently re-enrolled, the herd will be reassigned ''First Year Status'' and the 5-year process toward ''Certified Status'' shall begin again.

 c. Duty to Report Suspect Cervids. A program participant, the owner of a herd of farmed or captive CWD-susceptible cervids and all caretakers of that herd shall immediately report any cervid that shows signs that are consistent with CWD (such as staggering, drooling, wasting or unusual behavior) to the Department. Also, upon the discovery of any dead farmed or captive CWD-susceptible cervid aged 12 months or older, from a carcass in an advanced state of decomposition, the program participant, owner or caretaker shall immediately report this death to the Department. This report shall be made promptly to the Department Regional Office or by telephone to the number set forth in Section 5(a).

 d. 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 this Section 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, harvesting, culling or any other cause).

 e. 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 (d)(i), it shall be tested according to either of the following procedures:

 i. A person may 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.

 B. Deliver the carcass or head for CWD testing. The carcass or head shall be delivered to either a Department laboratory for this CWD testing, or to a laboratory that has been approved, in advance, by the Department and/or USDA, within 72 hours of the cervid's death, to perform this CWD testing.

 ii. As an alternative to the CWD testing procedure described in paragraph (i), the following procedure may be followed:

 A. Tissue samples shall be collected by one of the following:

 I. An accredited practitioner of veterinary medicine.

 II. An authorized State official.

 III. An authorized Federal official.

 IV. Another person who meets the current qualifications regarding authorized sample collectors, as prescribed by the United States Department of Agriculture/Animal and Plant Health Inspection Service (USDA/APHIS). A Department-certified CWD Technician does not meet the requirements of this subparagraph.

 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 that includes the official identification of the subject cervid.

 D. The tissue samples shall be delivered to the Department for testing, or to a laboratory that has been approved in advance by the Department and/or USDA, within 72 hours of the cervid's death, to perform CWD testing.

 f. 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 (d)(i)) 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 (d)(ii) and (d)(iii), it shall be tested according to the following procedures:

 i. Tissue samples shall be collected by one of the following:

 A. An accredited practitioner of veterinary medicine.

 B. An authorized State official.

 C. An authorized Federal official.

 D. A Department-certified CWD Technician.

 E. Another person who meets the current qualifications regarding authorized sample collectors, as prescribed by USDA/APHIS.

 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 that includes the official identification of the subject cervid.

 iv. The tissue samples shall, within 30 days of collection, be delivered to the Department for testing, or to a laboratory that has been approved in advance by the Department or USDA, or both, to perform CWD testing.

 v. As an alternative to the testing protocol described in Subsections (f)(i), (f)(ii), (f)(iii) and (f)(iv), a person may, within 72 hours of the cervid's death, collect and deliver either the entire carcass of the cervid or the entire head of the cervid to a Department laboratory for CWD testing, or to a laboratory that has been approved in advance by the Department and/or USDA to perform CWD testing. The person who collects or delivers the carcass or head need not be a sampler as described in Subsection (f)(i).

 g. Impact of Untestable Samples on Enrollment Status. The Department may lower the status of a herd that is enrolled in the Herd Certification Program, or move that herd to the Herd Monitored Program, if a sample from a dead cervid from that herd cannot be tested to determine whether that cervid has CWD. Adherence to the 72-hour deadlines established in Subsections (e)(ii) and (f)(ii) will be considered a mitigating factor by the Department in any reevaluation of herd status.

 h. Chain of Custody of Samples; Submission of Samples. A person may obtain Chain-of-Custody Forms and Sample Submission Forms from the Department as set forth in Section 5. A person submitting a sample (whether tissue samples, an entire carcass or an entire head) for analysis 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. The Chain-of-Custody Form shall clearly identify the source of the sample, 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 Department, a Department-approved laboratory or a USDA-approved laboratory for CWD testing. The Chain of Custody shall bear the signature, printed name and other identifying information with respect to each person who handles the sample. The completed Chain-of-Custody Form and the Submission Form shall be provided to a responsible person at the laboratory to which the sample is delivered.

 i. 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 shall have at least two forms of the Department or USDA/APHIS-approved, or both, animal identification attached. One form of identification must be official. If the other form of identification is not official, it shall be unique to the animal on the enrolled premises. Forms of identification that are Department-approved or USDA/APHIS-approved, or both, ''official'' forms of identification for purposes of this provision include the following:

 i. A tattoo of a unique number approved by the Department, or USDA/APHIS, or both.

 ii. A tamper resistant ear tag (with or without Radio Frequency Identification capability) bearing a unique 15-digit AIN or ISO compliant number.

 iii. A Department-issued metal ear tag, bearing a unique number provided by the Department.

 iv. A USDA/APHIS-issued metal ear tag, bearing a unique number provided by USDA/APHIS.

 v. An electronic implant device, such as a microchip, provided that an appropriate reader is immediately available wherever the animal is located.

 vi. Any other identification device approved by the Department, or USDA/APHIS, or both.

 j. Ongoing Record-Keeping Requirement. A program participant with a herd that is enrolled in the Herd Certification Program shall maintain up-to-date 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 1 month after each anniversary of the ''date of enrollment'' previously described in Section 9(b). These records shall include the following with respect to each subject cervid:

 i. An official identification as previously described in Subsection (i).

 ii. Either the second official identification or the unofficial identification that is unique to the animal on the enrolled premises, as previously described in Subsection (i).

 iii. The sex and date of birth of the subject cervid.

 iv. The date of departure and the destination of any subject cervid removed from the herd within the preceding 12 months; and the date of death and cause of death (if known) of any subject cervid that dies.

 v. If the subject cervid is new to the herd since the ''date of enrollment'' previously described in Section 9(b), designation of whether the subject was born to the herd or acquired from outside the herd and, if the latter is true, the source of the subject cervid.

 k. Ongoing Reporting Requirement regarding Removal of CWD-Susceptible Cervids from an Enrolled Herd or Wild CWD-Susceptible Cervids entering an Enrolled Herd. A program participant shall immediately report to the Department the removal of any farmed or captive CWD-susceptible cervid from the enrolled herd through theft or escape. A report of removal of a cervid shall clearly identify each cervid that was removed. A program participant shall immediately report to the Department if a wild CWD-susceptible cervid or any other CWD-susceptible cervid gains entrance into the enrolled herd. This reporting requirement is not applicable to additions to a herd as described in subsection (n) (titled Additions to the Herd). A report of a CWD-susceptible cervid gaining entrance to an enrolled herd shall clearly identify the individual cervid, to the extent identification information is known.

 l. Inspections. The Department or its agents acting under the authority and direction of the Department may, at intervals of no greater than 12 months, 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, whole herd inventory with individual animal identification, inspecting fences and otherwise determining whether the herd is being maintained in compliance with the Herd Certification Program.

 m. 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.

 n. Additions to the Herd. 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 the Herd Certification Program and has an equal or earlier enrollment date (month, day, year). This requirement applies regardless of whether a cervid is only added to an enrolled herd for a short period of time (Example: when a buck is moved to an enrolled herd for breeding season). If this requirement is not complied with, the herd enrollment date for the enrolled herd to which the CWD-susceptible cervid was added will be changed to that of the source of the herd addition, and herd status will be recalculated from that adjusted date.

 o. 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 by the seller and buyer including (as applicable) collection date, animal identification with respect to the cervid from which the cervid by-product was collected, animal identification 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.

 p. Intrastate Movement of Enrolled Cervids. Farmed or captive CWD-susceptible cervids that are enrolled under the Herd Certification Program may be moved intrastate, if the cervid has one or more of the forms of official identification described in Subsection (i), and this movement is also done in compliance with any other applicable intrastate movement requirements related to diseases other than CWD.

 q. 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 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, change the enrollment status of the enrolled herd to a lower status, or remove the herd from the CWD Herd Certification Program and enroll it under the CWD Herd Monitored Program. This action may be taken for violations such as failure to meet applicable mandatory testing requirements, animal identification requirements, record-keeping requirements or any other requirements imposed by this Order.

 10. CWD Herd Monitored Program.

 a. Program established. The Chronic Wasting Disease Herd Monitoring Program (Herd Monitoring Program), as established by the August 4, 2006 General Quarantine Order described in Section 2, is continued as the Chronic Wasting Disease Herd Monitored Program (Herd Monitored Program), and as otherwise modified by this Order.

 b. Duty to Report Suspect Cervids and Untestable Samples. The program participant, the owner of a herd of farmed or captive CWD-susceptible cervids and all caretakers of that herd shall immediately report any cervid that shows signs that are consistent with CWD (such as staggering, drooling, wasting or unusual behavior) to the Department. Also, upon the discovery of any dead farmed or captive CWD-susceptible cervid aged 12 months or older from a carcass in an advanced state of decomposition, the program participant, owner or caretaker shall immediately report this death to the Department. This report shall be made to the Department Regional Office or by telephone to the number set forth above in Section 5(a).

 c. Mandatory Testing for Farmed or Captive CWD-Susceptible Cervids designated as CWD Suspects. A program participant with a herd that is enrolled in the Herd Monitored Program shall be responsible to ensure that a farmed or captive CWD-susceptible cervid is tested according to either of the following procedures if it is enrolled in the Herd Monitored Program, shows signs (such as staggering, drooling, wasting or unusual behavior) that are consistent with CWD, and dies or is killed:

 i. A person may 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.

 B. Deliver the carcass or head for CWD testing. The carcass or head shall be delivered to either a Department laboratory for this CWD testing, or to a laboratory that has been approved, in advance, by the Department or USDA, or both, within 72 hours of the cervid's death, to perform this CWD testing.

 ii. As an alternative to the CWD testing procedure described in paragraph (i), the following procedure may be followed:

 A. Tissue samples shall be collected by one of the following:

 I. An accredited practitioner of veterinary medicine.

 II. An authorized State official.

 III. An authorized Federal official.

 IV. Another person who meets the current qualifications regarding authorized sample collectors, as prescribed by the United States Department of Agriculture/ Animal and Plant Health Inspection Service (USDA/APHIS). A Department-certified CWD Technician does not meet the requirements of this subparagraph.

 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 that includes the official identification of the subject cervid.

 D. The tissue samples shall be delivered to the Department for testing or to a laboratory that has been approved in advance by the Department or USDA, or both, within 72 hours of the cervid's death, to perform CWD testing.

 d. Mandatory Testing for CWD-Susceptible Cervids in Herds with a Cervid Source that is not enrolled in the Herd Certification Program. If a farmed or captive CWD-susceptible cervid that is 12 months of age or older is in an enrolled herd that contains one or more CWD-susceptible cervids that did not originate from that herd or a herd enrolled in the Herd Certification Program, does not exhibit signs (as described in Subsection (c)) that are consistent with CWD, and dies for any reason (including accident, natural causes, harvesting, culling or any other cause) or is sent to a slaughter facility, it shall be tested according to the testing protocol set forth in Subsection (f). If 30 such dead cervids are tested under this Subsection during a single 12-month period and are test-negative for CWD, this testing need not continue for the remainder of that 12-month period.

 e. Mandatory Testing for CWD-Susceptible Cervids in Herds Originating from Enrolled Herd Certification Program Herds.

 i. If a farmed or captive CWD-susceptible cervid that is 12 months of age or older is in an enrolled herd, and all of the CWD-susceptible cervids in the herd originate from herds that are enrolled in the Herd Certification Program, and such a CWD-susceptible cervid dies for any reason (including accident, natural causes, harvesting, culling or any other cause) or is sent to a slaughter facility, it shall be tested in accordance with the testing protocols set forth in Subsection (f). If 10% of the test-eligible CWD-susceptible cervids in the herd or 30 such cervids (whichever is less) are tested under this Subsection during a single 12-month interval and are test-negative for CWD, this testing need not continue for the remainder of that 12-month interval.

 ii. If a farmed or captive CWD-susceptible cervid that is 12 months of age or older is in an enrolled herd, and all of the CWD-susceptible cervids in the herd originate from herds that are enrolled in the Herd Certification Program and have achieved ''Certified Status'' (as described in Section 9(b)), and such a CWD-susceptible cervid dies due to accident, natural causes or unknown reason, it shall be tested in accordance with the testing protocols set forth in Subsection (f). This test requirement is not applicable to cervids that are harvested by hunting ranch clients, or are harvested for human consumption. If 30 such cervids are tested under this Subsection during a single 12-month interval and are test-negative for CWD, this testing need not continue for the remainder of that 12-month interval.

 f. 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 (c)) that are consistent with CWD, and is required to be tested because it is 12 months of age or older and to meet the requirements of Subsections (d) or (e), it shall be tested according to the following procedures:

 i. Tissue samples shall be collected by one of the following:

 A. An accredited practitioner of veterinary medicine.

 B. An authorized State official.

 C. An authorized Federal official.

 D. A Department-certified CWD Technician.

 E. Another person who meets the current qualifications regarding authorized sample collectors, as prescribed by USDA/APHIS.

 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 that includes the official identification of the subject cervid.

 iv. The tissue samples shall, within 30 days of collection, be delivered to the Department for testing, or to a laboratory that has been approved in advance by the Department or USDA, or both, to perform CWD testing.

 v. As an alternative to the testing protocol described in Subsections (f)(i), (f)(ii), (f)(iii) and (f)(iv), a person may, within 72 hours of the cervid's death, collect and deliver either the entire carcass of the cervid or the entire head of the cervid 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. The person who collects or delivers the carcass or head need not be a sampler as described in Subsection (f)(i).

 g. Chain of Custody of Samples; Submission of Samples. A person may obtain Chain-of-Custody Forms and Sample Submission Forms from the Department by the same means previously set forth in Section 5. A person submitting a sample (whether tissue samples, an entire carcass or an entire head) for analysis under the Herd Monitored 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. The Chain-of-Custody Form shall clearly identify the source of the sample, 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 Department, or a Department-approved laboratory, or a USDA-approved laboratory for CWD testing. The Chain of Custody shall bear the signature, printed name and other identifying information with respect to each person who handles the sample. The completed Chain-of-Custody Form and the Submission Form shall be provided to a responsible person at the laboratory to which the sample is delivered.

 h. Identification of Subject Animals and Carcasses. Each farmed or captive CWD-susceptible cervid that is within a herd that is enrolled in the Herd Monitored 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. Forms of identification that are Department-approved or USDA/APHIS-approved, or both, ''official'' forms of identification for purposes of this provision include the following:

 i. A tattoo of a unique number approved by the Department or USDA/APHIS, or both.

 ii. A tamper resistant ear tag (with or without Radio Frequency Identification capability) bearing a unique 15-digit AIN or ISO compliant number.

 iii. A Department-issued metal ear tag, bearing a unique number provided by the Department.

 iv. A USDA/APHIS-issued metal ear tag, bearing a unique number provided by USDA/APHIS.

 v. An electronic implant device, such as a microchip, provided that an appropriate reader is immediately available wherever the animal is located.

 vi. Any other identification device approved by the Department or USDA/APHIS, or both.

 i. Ongoing Record-Keeping Requirement. A program participant with a herd that is enrolled in the Herd Monitored Program shall maintain up-to-date 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 Monitored Program. These records shall include the following:

 i. Herd size (estimate if exact size is not known).

 ii. For each CWD-susceptible cervid with identification that is enrolled in the Herd Monitored Program:

 A. The unique number or identification information from the tattoo, tag, electronic implant device or other identification device described in Subsection (h).

 B. The sex of the animal.

 C. The date of birth of the animal.

 D. Clarification as to whether the animal was born into the herd or was acquired from outside the herd.

 E. If the animal was acquired from outside the herd, the name, address and telephone number of the source location from which the animal was acquired.

 iii. The date of departure and the destination (including name, address and telephone number) of any subject cervid removed from the herd within the preceding 12 months; and the date of death and cause of death (if known) of any subject cervid that dies.

 j. Ongoing Reporting Requirement regarding Removal of CWD-Susceptible Cervids from an Enrolled Herd or Wild CWD-Susceptible Cervids entering an Enrolled Herd. A program participant shall immediately report to the Department the removal of any farmed or captive CWD-susceptible cervid from the enrolled herd through theft or escape. A program participant shall immediately report to the Department if a wild CWD-susceptible cervid or any other CWD-susceptible cervid gains entrance into the enrolled herd. A report of removal of a cervid shall clearly identify the individual cervid. This reporting requirement is not applicable to additions to a herd as described in Subsection (i)(ii)(E). A report of a CWD-susceptible cervid gaining entrance to an enrolled herd shall clearly identify the individual cervid, to the extent identification information is known.

 k. Inspections. The Department or agents acting under authority and direction of the Department may, at its discretion and at reasonable times, inspect the premises upon which an enrolled herd of farmed or captive CWD-susceptible cervids is maintained. Inspections may include records review, checking individual animal identification, inspecting fences and otherwise determining whether the herd is being maintained in compliance with the Herd Monitored 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.

 l. Fencing. A herd of farmed or captive CWD-susceptible cervids that is enrolled under the Herd Monitored 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.

 m. Limitations on Intrastate Movement of Enrolled Cervids. Live farmed or captive CWD-susceptible cervids that are from a herd that is enrolled under the Herd Monitored Program may not be transported intrastate unless the destination is a hunting ranch or a slaughter facility and each cervid has the Department or USDA/APHIS-approved, or both, official animal identification (as described in Subsection (h)) attached and recorded before leaving the source premises. Those animals transported to a slaughter facility shall be sampled and tested for CWD in accordance with Subsection (d) or (e), as applicable. Those animals transported to a hunting ranch shall be sampled and tested for CWD in accordance with Subsections (d) or (e), as applicable.

 n. 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 Monitored Program if the following are met:

 i. The donor animal is from a herd enrolled in the CWD Herd Certification Program or its out-of-State equivalent. The source herd shall not have a CWD-positive animal, suspect animal, or exposed animal at time of collection. The premises of 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 by the seller and buyer including (as applicable) collection date, animal identification with respect to the cervid from which the cervid by-product was collected, animal identification 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.

 o. Changes of Status for Noncompliance. If a herd is enrolled in the CWD Herd Monitored 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, change the enrollment status of the enrolled herd to a lower status. This action may be taken for violations such as failure to meet applicable mandatory testing requirements, animal identification requirements, record-keeping requirements or any other requirements imposed by this Order.

 11. Participation in the Herd Certification Program or Herd Monitored 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 Monitored Program.

 12. Violations/Penalties. Any person violating the requirements of this Order shall be subject to criminal prosecution and/or civil penalties of up to $10,000 per violation.

 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. This Order is immediately effective upon publication in the Pennsylvania Bulletin, and shall remain in effect unless rescinded or modified by subsequent order.

RUSSELL C. REDDING, 
Secretary

[Pa.B. Doc. No. 11-208. Filed for public inspection February 4, 2011, 9:00 a.m.]



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