NOTICES
DEPARTMENT OF AGRICULTURE
General Quarantine Order; Influenza A Viruses in Ruminants; Mandatory Testing of Milk from Pennsylvania Dairy Farms
[54 Pa.B. 7873]
[Saturday, December 7, 2024]Recitals:
The following recitals set forth and describe the dangerous transmissible disease for which this General Quarantine Order; Influenza A Viruses in Ruminants, Mandatory Testing of Milk from Dairy Cattle Farms (General Quarantine Order) is instituted, specify the species of domestic animals affected by and subject to this General Quarantine Order, and provides the authority under which this General Quarantine Order is established.
A. Influenza A viruses have the potential to mutate and transfer into different host species.
B. The Highly Pathogenic Avian Influenza (HPAI) Eurasian lineage goose/Guangdong H5 clade 2.3.4.4 virus has been confirmed in wild birds and in poultry flocks across the United States in 2024.
C. HPAI has caused substantial loss in the past to the Pennsylvania poultry industry and has caused widespread losses to the poultry industry in states in which poultry have been infected.
D. Certain influenza A viruses, including H5 and H7 viruses, can cause severe disease in poultry and other avian species and have also been identified as a cause of clinical disease in other animals, including dairy cattle. In March 2024, an H5 influenza A virus was identified as a cause of a multistate outbreak of disease in dairy cattle. Clinical signs in dairy cattle include a decrease in feed consumption, with a simultaneous decrease in rumination and rumen motility; respiratory signs including clear nasal discharge; and subsequent acute drop in milk production. Additional clinical signs may include abnormal tacky or loose feces, lethargy, dehydration, and fever. Severely affected cattle may have thicker, concentrated, colostrum-like milk or produce no milk at all.
E. The ability of the H5 influenza A virus to be transmitted between poultry and cattle poses a threat to both the poultry and the cattle industries in Pennsylvania by threatening the economic wellbeing of the domestic animal and allied industries. In addition, H5 and H7 influenza A viruses in poultry and ruminants may pose a risk to farm workers due to their zoonotic potential.
F. Section 2321(a) of the Domestic Animal Law (relating to specific dangerous transmissible diseases) (3 Pa.C.S. § 2321(a)) establishes specific transmissible diseases as dangerous transmissible diseases within the meaning of the Domestic Animal Law.
G. Section 2321(d) of the Domestic Animal Law (relating to designation of additional dangerous transmissible disease through temporary order) provides, ''Upon the determination that a transmissible disease not listed in subsection (a) and not designated a dangerous transmissible disease through regulation under subsection (b) presents a danger to public health, to domestic animal health, to the safety or quality of the food supply or to the economic wellbeing of the domestic animal industries, the Department shall issue a temporary order proclaiming that transmissible disease to be a dangerous transmissible disease within the meaning of this chapter. . .'' (3 Pa.C.S. § 2321(d)).
H. The Department amended a previous Temporary Order Designating Dangerous Transmissible Diseases published in the Pennsylvania Bulletin on December 2, 2023 (53 Pa.B. 7373) to include ''Influenza A Viruses in Ruminants'' as a dangerous transmissible disease. The amended Temporary Order was published in the April 20, 2024, edition of the Pennsylvania Bulletin (54 Pa.B. 2098) and such designation was effective immediately upon publication of that edition.
I. Section 2329(a) of the Domestic Animal Law (relating to power to establish and enforce), authorizes the Department to 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. In addition to the aforedescribed domestic animals, a quarantine may apply to any goods, products, facilities, containers, vehicles or materials that may carry dangerous transmissible disease. . .and may be applied on or in or against any premises, area or locality as defined in this chapter.'' (3 Pa.C.S. § 2329(a)).
J. Section 2329 (related to quarantine) of the Domestic Animal Law (3 Pa.C.S. § 2329) establishes three different types of quarantine orders—Interstate and International (3 Pa.C.S. § 2329(c)), General (3 Pa.C.S. § 2329(d)) and Special (3 Pa.C.S. § 2329(e))—the Department may impose.
K. Section 2329(d) of the Domestic Animal Law provides specific authority to establish and enforce a general quarantine order ''. . .against any area or locality within this Commonwealth for any of the reasons set forth in subsection (a) 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. A general quarantine order may include any domestic animals, conveyances, containers, goods, products or materials that may carry dangerous transmissible disease. . .and may include any area or locality, including all buildings, structures, premises and equipment located therein.'' (3 Pa.C.S. § 2329(d)).
L. Section 2327(a) of the Domestic Animal Law provides, ''The department shall have the authority to regularly monitor the domestic animal population of this Commonwealth to determine the prevalence, incidence and location of transmissible diseases. . .'' (3 Pa.C.S. § 2327(a)).
M. Surveillance of Pennsylvania dairy cattle herds through milk testing is necessary to determine if influenza A is circulating in dairy cattle due to the risk posed to other dairy cattle herds, poultry flocks, and farm workers.
Order:
With the foregoing recitals incorporated into this General Quarantine Order by reference, the Department hereby establishes a General Quarantine Order related to mandatory testing requirements for Pennsylvania dairy cattle herds. This General Quarantine Order is established 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. Definitions
Approved inspector. A person who has been licensed by the Department to perform dairy farm inspections.
Approved sampler. A persons certified by the Department to obtain sample of milk or milk products for analysis by a Pennsylvania-approved dairy laboratory. Certified industry inspector. An approved inspector who has been licensed by the Department to inspect dairy farms on which milk is produces for an interstate milk shipper.
Bulk milk hauler/sampler. As defined in the Grade ''A'' PMO.
Dairy cattle. Cattle belonging to breeds raised for milk production purposes, or crosses thereof, included in the Genus Bos.
Grade ''A'' PMO. The 2023 revision of the Grade ''A'' Pasteurized Milk Ordinance and its appendices, as published by the Food and Drug Administration of the United States Department of Health and Human Services.
Industry milk sampler. As defined in the Grade ''A'' PMO.
Infected Premises. Premises where a presumptive positive case or confirmed positive case of influenza A in ruminants or poultry exists based on laboratory results, compatible clinical signs, HPAI case definition, and international standards.
Infected Zone. The 3-kilometer radius surrounding an infected premises. Milk tanker. Bulk delivery truck that delivers raw milk from a dairy farm to a processor.
NVSL. National Veterinary Services Laboratories.
Pennsylvania dairy farm. A farm located within the Commonwealth wherein dairy cattle are producing milk for sale.
Poultry. All birds reared or kept in captivity for the production of any commercial animal products or for breeding for this purpose, fighting cocks used for any purpose, and all birds used for restocking supplies of game or for breeding for this purpose, until they are released from captivity.
USDA. United States Department of Agriculture.
2. Quarantine Area. The area covered by this General Quarantine Order is the entire Commonwealth of Pennsylvania.
3. Mandatory Milk testing requirements.
(a) No later than November 26, 2024, any milk processor in Pennsylvania that is purchasing or receiving bulk raw milk directly from a Pennsylvania dairy farm or milk cooperative, and any individual Pennsylvania dairy farm or milk cooperative that is delivering bulk raw milk from a Pennsylvania dairy farm to an out-of-state milk processor, shall begin collecting and submitting samples of raw milk taken from each compartment of each milk tanker to the Department for testing in the following manner:
(i) Milk tanker samples must be collected on a schedule and at a frequency that ensures that at least one sample of milk from every Pennsylvania dairy farm in every pickup route is collected at least once every 14 days.
(ii) Collection of initial samples may be staggered so that samples from each Pennsylvania dairy farm in every pickup route are collected within the first 14 days after November 26, 2024. A staggered schedule of sample collection should be maintained so that approximately the same number of samples are collected and submitted each day during each 14-day period.
(iii) For milk purchased or received directly from a Pennsylvania dairy farm or milk cooperative by a milk processing plant in Pennsylvania, samples must be collected at the milk processing plant by an industry milk sampler.
(iv) For milk being delivered to an out of state processing plant by an individual Pennsylvania dairy farmer or a milk cooperative handling or marketing milk on behalf of individual dairy farmers, the sample must be collected by a bulk milk hauler/sampler.
(v) Samples must be submitted within 48 hours of collection in tubes provided by the Department. If hand delivering, samples must be delivered to the nearest Pennsylvania Animal Diagnostic Laboratory System lab. If mailing, samples must be submitted to: The Animal Diagnostic Laboratory, 131 Pastureview Rd. University Park, PA 16802.
(vi) Samples shall be accompanied by a PADLS submission form that indicates the number of farms contributing to each sample, the USDA-issued premises ID of the processing plant, individual farm, or cooperative submitting the sample, number of samples included in the submission, date of collection for each sample and the name of the sampler for each sample. Multiple samples may be included on a single submission form.
(vii) All purchasers, receivers, or handlers of raw bulk milk from a Pennsylvania farm shall keep records adequate to assure compliance with subsection 3(a) and to assure a sample of milk that tests positive or non-negative for Influenza A virus may be traced back to the Pennsylvania dairy farm from which that milk originated.
(b) If a milk tanker sample tests positive or non-negative for Influenza A virus, the following shall apply:
(i) The purchaser shall provide the Department access to the identification of all Pennsylvania dairy farms from which milk was collected on that tanker within 12 hours of the request.
(ii) The Department will collect and test milk samples from each dairy farm identified under subsection (i).
(iii) If test results confirm a positive or non-negative finding for Influenza A virus on a dairy farm, the Department will establish and post an order of special quarantine upon that farm, identify that farm as an infected premises and establish an Infected Zone surrounding that farm. The requirements established in section (c) of this General Quarantine Order will become applicable and will be implemented.
(c) Additional requirements will apply if infected premises are present in the Commonwealth.
i. All dairy cattle herds located within the Infected Zone shall submit bulk tank or in-line milk samples for the purpose of surveillance for influenza A. Each herd must have a USDA issued federal premises identification number registered with the Department.
ii. Testing and sampling on each premises with dairy cattle within the Infected Zone will continue at a frequency and duration set by the Department based upon epidemiological analyses until the Infected Zone is closed by the Department.
iii. The Department possesses the authority to perform additional surveillance and testing outside the Infected Zone and may assert and utilize that authority as deemed necessary.
iv. The Department will continue surveillance testing under section 3 of this General Quarantine Order to determine prevalence of disease in other parts of the Commonwealth.
(d) The Department reserves the ability to do additional testing as deemed appropriate from any milk quality testing laboratory, milk processor, or individual farm.
4. Milk sample requirements upon finding of positive or non-negative sample.
(a) Milk samples shall be collected and submitted by any of the following:
(i) An approved inspector, approved sampler or certified industry inspector,
(ii) Federal or State officials or alternative samplers selected and approved by USDA and the Department.
(iii) Category II Accredited Veterinarians.
(b) The sampling schedule will be determined by the Department and will be conveyed in writing to milk processors and individual farms.
5. Testing procedure. Samples shall be submitted to a Pennsylvania Animal Diagnostic Laboratory System (PADLS) laboratory according to sample submission guidelines provided by the laboratory and available at http://padls.agriculture.pa.gov. Each sample collected and submitted shall be tested for influenza A virus using polymerase chain reaction (PCR) testing under protocols approved by NVSL.
6. Reporting of premises information.
(a) The milk processor or milk quality laboratory shall submit samples to PADLS under their own USDA issued federal premises identification number and shall report within 24 hours the source location(s) of individual samples to the Department upon request.
(b) Individual farms submitting bulk tank or in-line samples shall report their USDA issued federal premises identification number on the PADLS submission form.
7. Violations and Penalties.
Any person violating the requirements of this Order shall be subject to enforcement and penalties as are allowed under the provisions of the Domestic Animal Law (3 Pa.C.S. § 2301 et seq.), which include criminal prosecution, civil penalties of up to $10,000 per violation, injunctive relief, or any combination of those penalties.
8. No Restriction on Further Action by the Department.
This General Quarantine Order shall not be construed as limiting the Department's authority to establish additional quarantine or testing requirements on imported cattle or to limit the Department's authority under the Domestic Animal Law or any other statutes or regulations administered by the Department.
9. Contact information.
Questions regarding this General Quarantine Order may be directed to the Commonwealth of Pennsylvania, Department of Agriculture, Bureau of Animal Health, 2301 North Cameron Street, Harrisburg, PA 17110 or by telephone at 717-772-2852, or email at RA-ahds@pa.gov.
10. Effective Date.
This General Quarantine Order in its entirety shall become effective immediately upon signature of the Secretary of the Pennsylvania Department of Agriculture and shall remain in effect for twelve months following publication unless rescinded, extended, or modified by a subsequent Order.
RUSSELL REDDING,
Secretary
[Pa.B. Doc. No. 24-1729. Filed for public inspection December 6, 2024, 9:00 a.m.]
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