NOTICES
DEPARTMENT OF AGRICULTURE
General Quarantine Order; Highly Pathogenic Avian Influenza Samplers
[53 Pa.B. 7736]
[Saturday, December 16, 2023]Recitals
A. Avian influenza, ''. . .an infectious disease of poultry cause by Type A. influenza virus,'' including highly pathogenic avian influenza (HPAI), is designated as a ''dangerous transmissible disease'' of animals under the provisions of the Domestic Animal Law (3 Pa.C.S.A. §§ 2301—2389), at 3 Pa.C.S.A. § 2321(a)(6).
B. The Pennsylvania Department of Agriculture (Department), under the edicts established at section 2327 of the Domestic Animal Law (3 Pa.C.S.A. § 2327) (related to disease surveillance and detection) has the authority and duty to carry out disease surveillance and detection and more specifically to regularly monitor the domestic animal population of this Commonwealth to determine the prevalence, incidence and location of transmissible diseases or contamination by hazardous substances.
C. The Department, under the provisions set forth at section 2329 of the Domestic Animal Law (3 Pa.C.S.A. § 2329) (related to quarantine) has the authority to establish three different types of quarantine orders—Interstate and International, General and Special. The Department may establish a Quarantine Order, ''Whenever a dangerous transmissible disease. . .exists anywhere within or outside of this Commonwealth, or whenever it is deemed advisable to test or treat any domestic animal upon the reasonable suspicion that it has contracted or been exposed to a dangerous transmissible disease. . .or whenever the testing or treatment of a domestic animal indicates that the domestic animal has been exposed to a dangerous transmissible disease. . .so as to render future accurate testing for recent exposure of that domestic animal to that dangerous transmissible disease. . .impractical or impossible, the department shall have the power to establish and enforce quarantines of any such infected, exposed, contaminated, suspected or susceptible domestic animal. . .'' (3 Pa.C.S.A. § 2329(a)).
D. The Department may establish and enforce a general quarantine order within the Commonwealth for any of the reasons set forth in section 2329(a) of the Domestic Animal Law, and provided in paragraph C above, ''. . .to prevent a dangerous transmissible disease. . .from being carried into, within, from or out of the area or locality that is subject to the quarantine. . .''
E. Section 2321 (related to dangerous transmissible diseases) of the Domestic Animal Law sets forth, at subsection (a), dangerous transmissible diseases (3 Pa.C.S.A. § 2321(a)). Section 2321(d) (related to designation of additional dangerous transmissible diseases through temporary order) allows the Department to designate additional transmissible diseases determined to, ''. . .present a danger to public health, to domestic animal health, to the safety or quality of the food supply or to the economic well-being of the domestic animal industries. . .'' as dangerous transmissible diseases through the issuance of a temporary order (3 Pa.C.S.A. § 2321(d)).
F. The dangerous transmissible diseases listed at section 2321(a) of the Domestic Animal Law and those designated by the Department through a temporary order are known to exist within or outside of this Commonwealth and have been determined to pose a danger to public health, domestic animal health, the safety or quality of the food supply or to the economic well-being of the domestic animal industries.
G. HPAI and other dangerous transmissible diseases of poultry are of concern to the entire Pennsylvania poultry industry and may severely limit the market for Pennsylvania poultry products or cause production losses or death in poultry flocks within and outside of the Commonwealth if not detected and controlled.
H. HPAI, in particular, has caused significant loss in the past to the Pennsylvania poultry industry and to the poultry industry in other states and as a whole.
I. Regulatory requirements for testing surveillance of poultry to determine the existence or spread of a dangerous transmissible disease in the Commonwealth exist to maintain, or to obtain, a disease-free status in the Commonwealth and the United States.
J. Regulatory surveillance for movement of poultry may be required for intrastate, interstate, and international commerce, and for entry into exhibitions or markets.
K. When HPAI has been identified in a Commonwealth flock, a Control Area (approximately a 10 kilometer radius around the infected premises), or a Surveillance Zone (approximately a 10 kilometer radius around the Control Area), or both may be placed by the Department to determine if additional flocks have been infected and to control the spread of disease.
L. Other areas may be designated for surveillance testing by the Department by a general quarantine order.
M. Surveillance testing of poultry flocks in a Control Area, Surveillance Zone or other area designated by a general quarantine order is required for surveillance purposes and, in a Control Area, for movement purposes.
N. Additional testing requirements may be placed for flocks being moved into other states by the state of destination when HPAI is identified in the Commonwealth.
O. Due to biosecurity concerns, it is preferable to reduce human and vehicular traffic onto and off a poultry premises located within a Control Area or Surveillance Zone. Additionally, Certified Poultry Technicians or poultry veterinarians who routinely sample these flocks may be unavailable to collect samples and swabs due to biosecurity concerns associated with going from one poultry premises to another.
P. Due to additional testing requirements mandated during a dangerous transmissible disease outbreak, there may be an inadequate number of Certified Poultry Technicians and poultry veterinarians available to collect samples and swabs necessary for surveillance and movement purposes.
Q. Poultry flocks located in poultry-dense areas of the Commonwealth may pose a high risk to the poultry industry and additional surveillance and testing requirements, as determined by the Department, may be implemented through an Interstate and International Quarantine Order, General Quarantine Order, or Special Quarantine Order.
R. This ''General Quarantine Order; Highly Pathogenic Avian Influenza Samplers'' establishes training and testing requirements necessary for poultry producers or their employees, or both, to be certified by the Department as HPAI Samplers to collect swab samples from poultry on Department-prescribed premises for testing for HPAI during a Declared Disease Outbreak (HPAI) in the Commonwealth.
S. Only persons trained and certified in accordance with the provisions set forth in this ''General Quarantine Order; Highly Pathogenic Avian Influenza Samplers'' may act as HPAI Samplers for the collection of swab samples for testing for HPAI for regulatory purposes in prescribed locations and during a Declared Disease Outbreak (HPAI), as determined by the Department.
Order
The Department hereby establishes this ''General Quarantine Order; Highly Pathogenic Avian Influenza Samplers'' (Order), incorporating the foregoing recitals. This Order is entered under authority of the Domestic Animal Law (at 3 Pa.C.S.A. § 2329) and § 1702 of the Administrative Code of 1929 (71 P.S. § 442), and establishes the following quarantine restrictions and standards with respect to training and testing of persons to become certified as HPAI Samplers, and provides standards for the collection of swab samples for testing for HPAI for regulatory purposes only in Department-prescribed locations and during a Declared Disease Outbreak (HPAI) as determined by the Department.
1. General.
For purposes of this Order, the term ''poultry'' includes all domesticated fowl, including chickens, turkeys, ostriches, emus, rheas, cassowaries, waterfowl, and game birds, except doves and pigeons, which are bred for the primary purpose of producing eggs or meat, or as otherwise defined under subpart A of the current version of Title 9 of the Code of Federal Regulations (CFR)—National Poultry Improvement Plan (NPIP).
2. Purpose.
This Order allows for qualified persons to become certified as HPAI Samplers for the collection of samples and swabbing of poultry for the surveillance and detection of HPAI, during a Declared Disease Outbreak (HPAI), on Department-prescribed poultry premises, and provides standards for the collection of swabs samples for testing for the detection of HPAI. Certified HPAI Samplers will enhance the Department's ability to surveil for and detect dangerous transmissible diseases in accordance with the Domestic Animal Law. This Order allows for a more proactive and preventative approach to quick detection and eradication of current and future dangerous transmissible diseases of poultry through surveillance, monitoring, and testing by the poultry industry. Such an approach furthers the legislative mandate of section 2327 of the Domestic Animal Law1 (related to disease surveillance and detection) and provides greater protection to the poultry population and industry in this Commonwealth. This Order delineates education and testing criteria that will allow for and require the certification of private sector individuals to carry out domestic poultry sampling and thereby enhance monitoring, detection, and containment of dangerous transmissible diseases of poultry.
3. Scope of certification.
This Order allows persons certified as HPAI Samplers in the Commonwealth of Pennsylvania to perform the duties of a HPAI Sampler on Department-prescribed premises only within the Commonwealth of Pennsylvania and only within a Control Area, Surveillance Zone, or other area as designated by a general quarantine order and only during a Declared Disease Outbreak (HPAI). Final certification shall be obtained prior to any person undertaking any sampling or other activity requiring certification under this Order.
4. Qualifications for certification.
(a) A Certified HPAI Sampler may carry out the duties established in this Order during a Declared Disease Outbreak (HPAI) and in any Control Area, Surveillance Zone or other area designated by a general quarantine order.
(b) Persons certified by the Department as HPAI Samplers may continue to carry out the duties and functions bestowed upon them under this Order so long as their certification remains valid and until such time as the Department has rescinded the quarantine order creating the Control Area, Surveillance Zone, or other area in which the HPAI Sampler is working.
(c) Nothing in this Order may or shall supplant the provisions of the Veterinary Medical Practice Act2 or its attendant regulations regarding the practice of veterinary medicine. Persons certified as HPAI Samplers may only carry out those practices that would not rise to the level of veterinary medical practice as defined under the Veterinary Medicine Practice Act.
(d) Certification of a HPAI Sampler shall only last until the date on which the Department has rescinded the Declared Disease Outbreak (HPAI). After such rescission the authority of a Certified HPAI Sampler to carry out the duties assigned under this Order shall terminate. A person may continue to renew their annual HPAI Sampler certification, as set forth in section 9. Of this Order but, may not carry out any of the duties of a Certified HPAI Sampler until such time as the Department issues a new Declared Disease Outbreak (HPAI).
(i) If a new Declared Disease Outbreak (HPAI) occurs within 12 months after the Department's rescission of the previous Declared Disease Outbreak (HPAI) the HPAI Sampler may resume their duties as a HPAI Sampler for the remainder of the calendar year in which the new Declared Disease Outbreak (HPAI) was issued, but must then meet the renewal standards established in section 9. of this Order unless an extension is granted by the Department due to an extended disease outbreak. Stakeholders shall be notified by the Department of any extensions.
(ii) A Declared Disease Outbreak (HPAI) occurring more than 12 months after the Department's pronouncement of the rescission of the previous Declared Disease Outbreak (HPAI) shall require persons that have not maintained their certified status under section 9. of this Order to be recertified and meet the certification requirements of this Order prior to resuming duties and functions as a Certified HPAI Sampler.
5. General Certification Requirements.
(a) To be certified as a HPAI Sampler, a poultry producer or their employee, or both, shall:
(i) Complete the required and appropriate certification course established by this Order, including review of the current training materials provided by the Department;
(ii) Fully and accurately complete a High Path Avian Influenza PCR Submission Form; and
(iii) Demonstrate to the satisfaction of the Approved Trainer as defined in section 6.(b) of this Order proficiency in oropharyngeal swabbing (including swabbing of the choanal slit) for gallinaceous species of poultry, or cloacal swabbing of waterfowl, or both, depending on which species the HPAI Sampler will be sampling.
(b) All applicants to be certified as HPAI Samplers who will sample birds destined for a live bird market shall fully and accurately complete a live bird market HPAI poultry inspection certificate (PIC) as part of their training.
(c) Swabbing proficiency must be demonstrated within two weeks after completion of the certification course using the training materials provided by the Department as described in sections 5(a)(i), (ii), and (iii), and section 5(b) has been successfully completed.
6. Certification Training.
(a) General. The Department has developed the HPAI Sampler certification course in accordance with the standards established in this Order. The Department may administer the course or may approve vendors to provide training.
(b) Approved Trainers. All certification courses shall be conducted by a person (trainer) approved by the Department. An approved trainer shall be either a Department veterinarian or inspector, a United State Department of Agriculture veterinarian or inspector, a Certified Poultry Technician, a licensed private veterinarian with poultry experience, a Pennsylvania State University or University of Pennsylvania veterinarian or poultry specialist, or other designee of the Department. Approved trainers shall be responsible for the certification training of all HPAI Samplers.
(c) Approved trainers shall provide the trainee name, address, and contact information to the Department for each trainee, to include a working phone number for the trainee; and if available an email address for the trainee or associated contact. This information shall be provided to the Department using a Department-approved spreadsheet format.
(d) Integrators. For producers employed by an integrator, and their employees, on a Department-prescribed poultry premises, the integrator shall be responsible for the certification training for HPAI Samplers and shall utilize the entities designated in section 6(b) above to carry out the training using current training materials provided by the Department.
(e) Independent Producers. For independent producers and their employees, the training shall be conducted by the entities designated in section 6(b) above. Independent producers and their employees may be trained by the entities designated in section 6(b) above who are employed by service companies which routinely provide consultation services for the flocks for which the independent producers and their employees are seeking certification to sample.
(f) HPAI Sampler Certification. After receipt of the completed training log the Department will create an active HPAI Sampler account for each person who successfully completed the training. Persons wishing to act as HPAI Samplers must have an active status as a Certified HPAI Sampler with the Department before collecting swab samples for regulatory testing. The Department will provide a certificate with an expiration date for each HPAI Sampler.
(g) Course content. At a minimum the course content shall include information and training necessary to meet the criteria established in section 8 of this Order, including training related to applicable provisions of the Domestic Animal Law and its attendant regulations, Department Orders regarding poultry, and identification of transmissible and reportable diseases of poultry (HPAI).
7. Access to Training.
(a) General. Current training materials will be provided by the Department to any person designated by the Department as an approved trainer, as set forth in paragraph 6(b) of this Order. Current training materials will be provided to approved trainers on at least an annual basis, or as amendments are made to the training materials, whichever occurs first.
(i) Revisions to sampling protocols will be provided to approved trainers as they become available.
(ii) Approved trainers shall provide certified HPAI Samplers trained by them with any Department updates to training or protocol materials throughout the year in a timely manner.
(b) Training Courses. In-person training will be offered by the Department or designee at least once per calendar year if deemed necessary by the Department. Training courses will be offered at various locations across the Commonwealth in a manner that will assure reasonable coverage and access, especially in poultry-dense areas.
(c) Approved Trainer Suspension. The Department may suspend an individual trainer's privileges to provide training at the Department's discretion if there are ongoing violations from certified HPAI Samplers trained by them.
8. Certification Criteria.
(a) At a minimum, the successful completion of the training course, completion of form(s), and demonstration of swabbing of poultry, as established in sections 5 and 6 of this Order, will demonstrate an applicant's understanding of and technical knowledge and proficiency relating to the duties set forth in this Order.
(b) The certification course and training requirements for a HPAI Sampler shall, at a minimum, address proper methods for the following:
(i) The collection of swab samples of sufficient quantity and quality for regulatory testing from poultry in accordance with applicable statutory and regulatory standards, and orders of the Department.
(ii) Handling, packaging, labeling, and timely submission of samples in accordance with applicable statutory and regulatory standards, and orders of the Department, and in a biosecure manner.
(iii) Comprehensive, timely and accurate completion of sample submission forms and all other forms required by the Department or the United States Department of Agriculture.
(iv) Reporting of any flock suspected to be infected with HPAI to the Department.
(v) Understanding of basic on-farm biosecurity principles.
(c) Criteria. The following establish the criteria related to certification and maintaining certification under this Order:
(i) A person seeking to act as a HPAI Sampler shall complete the certification training and courses required by this Order, including course work, swab sample collection training and demonstration of sampling competency; successful completion of a HPAI PCR Submission Form; and successful completion of a HPAI Poultry Inspection Certificate if they will be sampling birds destined for a live bird market.
(ii) A certified HPAI Sampler shall maintain certification during the Declared Disease Outbreak (HPAI) in accordance with the requirements set forth in this Order.
(iii) A certified HPAI Sampler shall conduct such sampling and other related activities in accordance with the requirements of this Order and any order issued by the Department.
9. Renewal for HPAI Sampler certification.
(a) The authority to continue to carry out the duties of a Certified HPAI Sampler shall end as of the date the Department rescinds the Declared Disease Outbreak (HPAI). After that date, the authority of a Certified HPAI Sampler to carry out the duties assigned under this Order shall terminate. A person may however continue to renew their annual HPAI Sampler certification, as set forth in this section but, may not carry out any of the duties of a Certified HPAI Sampler until such time as the Department issues a new Declared Disease Outbreak (HPAI).
(b) Certification as a HPAI Sampler shall expire on September 1 of each calendar year, and training as described in sections 4, 5, 6, and 8 of this Order is required for recertification or continued certification. A training log in a Department-approved format for the HPAI Sampler shall be submitted to the Department prior to September 1 of the same calendar year for the HPAI Sampler to remain active.
(b) Failure of a HPAI Sampler to be properly trained and certified and included in a training log in a Department-approved format submitted to the Department prior to September 1 of each calendar year will result in the following:
(i) The person's certification shall lapse, and the person will no longer be approved to act as a Certified HPAI Sampler.
(ii) The person may not continue to act or hold themselves out as a Certified HPAI Sampler.
(iii) Continuing to act or hold oneself out as a Certified HPAI Sampler shall be a violation of this Order and shall subject the person to the penalties provided for at sections 2383 (related to enforcement and penalties) and 2386 (related to civil remedy) of the Domestic Animal Law (3 Pa.C.S.A. §§ 2383 and 2386).
(iv) The person shall be required to successfully complete the certification training required under this Order to act as a Certified HPAI Sampler.
10. Duties and Limitations.
(a) Any person certified as a HPAI Sampler may engage in carrying out the duties and procedures within the scope of their certification as outlined under the provisions of this Order.
(b) A Certified HPAI Sampler may carry out the following:
(i) The collection of swab samples of sufficient quantity and quality for regulatory testing from poultry in accordance with applicable statutory and regulatory standards, and orders of the Department;
(ii) Handling, packaging, labeling, and timely submission of samples in accordance with applicable statutory and regulatory standards, and orders of the Department, and in a biosecure manner;
(iii) Comprehensive, timely and accurate completion of sample submission forms and all ther forms required by the Department or USDA; and
(iv) Collect samples from the flock(s) within a Control Area, Surveillance Zone, or other area as designated by a general quarantine order, and during a Declared Disease Outbreak (HPAI).
(v) Collect samples from a flock(s) under their care on a Department-prescribed premises.
(c) Certified HPAI Samplers may only collect samples for regulatory purposes if the flock which they are sampling is located in a Control Area or Surveillance Zone in place for control of a dangerous transmissible disease and designated by the Department, or in an area otherwise designated by the Department by a general quarantine order, and during a Declared Disease Outbreak (HPAI).
(d) A Certified HPAI Sampler may only collect the type of swab sample for which they are certified.
(e) A Certified HPAI Sampler shall immediately report suspected transmissible and reportable diseases in accordance with applicable statutory and regulatory standards, and orders of the Department.
(f) Being certified as a HPAI Sampler shall not entitle the person to perform any action or function for which a veterinary license, a certification as a veterinary technician, or a certification as a Certified Poultry Technician3 is required.
(g) If contact information changes for a HPAI Sampler at any time during the calendar year, updated contact information shall be provided to the Department within 10 business days.
11. Department oversight. The Department may observe a Certified HPAI Sampler performing the duties of a HPAI Sampler to assure compliance with the provisions of the Domestic Animal Law and this Order, and to assure proper procedures and protocols are being instituted and followed, and may conduct sampling and testing of its own to verify and assure the accuracy of the sampling being conducted by a HPAI Sampler.
12. Comprehension. If the applicant fails any part of the certification training, including failure to comprehend the training materials, to demonstrate adequate skills in collecting swab samples, or to properly complete the HPAI PCR Submission Form or the HPAI PIC (if applicable), the name of that applicant shall not be submitted to the Department for certification as a HPAI Sampler.
13. Duty to report. Consistent with the purpose of the Domestic Animal Law and the provisions established at section 2327 (related to disease surveillance and detection) (3 Pa.C.S.A. § 2327(b)), a Certified HPAI Sampler shall, immediately upon receiving information thereof or observing clinical signs consistent with a transmissible disease or reportable foreign animal disease, report to the Department each case of any transmissible disease, dangerous transmissible disease or foreign animal disease Failure to report s shall be considered a violation of this Order.
14. Violations and Penalties.
(a) Denial, suspension and revocation of certification. The Department may, after written notice, including a statement of the reasons therefore, deny, suspend, or revoke the certification of a HPAI Sampler for any of the following:
(i) A violation of the Domestic Animal Law, this Order or any order issued by the Department.
(ii) Failure of a Certified HPAI Sampler to meet the requirements of certification.
(iii) Inconsistency and demonstration of a lack of knowledge in the skills and techniques necessary to carry out the duties of a Certified HPAI Sampler.
(iv) Deficiencies in sample collection, sample handling, and sample submission requirements and criteria established by the Department.
(v) Failure to complete certification training, or renew certification in the established timeframe.
(vi) Being unwilling or unable to carry out the duties of a Certified HPAI Sampler
(vii) Falsifying information, including on applications, reports, records or correspondence with the Department.
(viii) A violation of any provision of the Domestic Animal Law, or its attendant regulations, an order of the Department or any requirement of certification, record keeping or other provision of this Order.
(ix) It shall be unlawful for any person to impede, hinder or interfere with the Department entering upon a premises or elsewhere in the performance of duties imposed under a quarantine order or for the sampling or testing of a domestic animal or to refuse to confine a domestic animal so as to allow testing without undue burden on the official conducting the test or to fail to present the person's domestic animals for testing by the Department under authority of this Order after reasonable notice of the proposed testing has been given.
(x) It shall be unlawful for any person who has knowledge that a domestic animal is infected with a dangerous transmissible disease or has been exposed to a dangerous transmissible disease or has been contaminated by a hazardous substance to conceal or attempt to conceal such a domestic animal or knowledge of such a domestic animal from the Department.
(b) Appeal and request for a hearing. A Certified HPAI Sampler may request a hearing, in writing, within fifteen (15) days of receipt of the Department's written notice of the proposed denial, suspension or revocation of their HPAI Sampler certification or any proposed civil penalties to be assessed by the Department, as allowed under section 2383(b) of the Domestic Animal Law (3 Pa.C.S.A. § 2383(b)). The written request shall be sent to the Bureau of Animal Health and Diagnostic Services, Agriculture Building, 2301 North Cameron Street, Harrisburg, Pennsylvania 17110. The written request for a hearing must clearly set forth the basis of any appeal, and clearly identify the relevant issues or objections to be resolved. If you deny or challenge any averment in the Department's proposed order of denial, revocation or suspension, the written appeal notice must identify that averment by number and describe the general basis for your denial or challenge. The scope of any subsequent administrative hearings or proceedings would be limited to those issues and objections set forth in the written appeal notice. No suspension, denial or revocation of certification or civil penalty issued shall become effective until the time to appeal the proposed action has expired and the proposed order has thus become final or, where a hearing is requested, a hearing in the matter has been completed and a final order of the Department has been issued.
(c) Suspended certification. Upon final suspension, a Certified HPAI Sampler whose certification has been suspended may not operate as a HPAI Sampler until that person has successfully completed the required certification requirements and other standards set forth in the final suspension adjudication.
(d) Denied or Revoked certification. A Certified HPAI Sampler whose certification has been denied or revoked may not operate as a HPAI Sampler until that person has completed the required certification requirements and any other standards established in the final order issued by the Department.
15. Criminal and civil penalties. The Department may impose those criminal and civil penalties specifically established at section 2383 of the Domestic Animal Law (3 Pa.C.S.A. § 2383) for any violation of the Domestic Animal Law or any rule regulation or order established thereunder.
16. Civil remedy. In addition to any other action or remedy sought, the Department may seek any civil remedy, as specifically established at section 2386 of the Domestic Animal Law (3 Pa.C.S.A. § 2386).
18. Continuing authority. This Order shall not be construed as limiting the Department's authority to establish additional requirements for initial or continued certification of HPAI Samplers or to limit any authority the Department possesses under the Domestic Animal Law or any other Act or Law administered by the Department.
19. Effective date. This Order is effective upon publication in the Pennsylvania Bulletin.
RUSSELL REDDING,
Secretary
[Pa.B. Doc. No. 23-1724. Filed for public inspection December 15, 2023, 9:00 a.m.] _______
1 3 Pa.C.S.A. § 2327.
2 Veterinary Medicine Practice Act (Act of December 27, 1974, P.L. 995, No. 326, as amended) (63 P.S. § 485.1 et seq.).
3 Veterinary Medicine Practice Act (Act of December 27, 1974, P.L. 995, No. 326, as amended) (63 P.S. § 485.1 et seq.), General Quarantine Order; Certified Poultry Technicians (49 Pa.B. 3088) (Saturday, June 15, 2019).
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