US Swine Health Improvement Plan

DEPARTMENT OF AGRICULTURE <SUBAGY>Animal and Plant Health Inspection Service</SUBAGY> <CFR>9 CFR Parts 148 and 149</CFR> <DEPDOC>[Docket No. APHIS-2022-0061]</DEPDOC> <RIN>RIN 0579-AE75</RIN> <SUBJECT>US Swine Health Improvement Plan</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Animal and Plant Health Inspection Service, USDA. <HD SOURCE="HED">ACTION:</HD> Proposed rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> We are proposing the creation of regulations governing the US Swine Health Improvement Plan (US SHIP). US SHIP would be a voluntary livestock improvement program aimed at improving biosecurity, traceability, and disease surveillance for swine health. The swine industry has requested the establishment of US SHIP, which builds on an existing pilot program initiated by industry. We propose to codify US SHIP as a Federal regulatory program and allow participating sites to obtain certifications of disease-monitored status for African swine fever and classical swine fever. Establishment of US SHIP would allow participating sites to market their products with the relevant certification status, which could limit disruptions to international and interstate commerce during outbreaks. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> We will consider all comments that we receive on or before January 30, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> You may submit comments by either of the following methods: • <E T="03">Federal eRulemaking Portal:</E> Go to <E T="03">www.regulations.gov.</E> Enter APHIS-2022-0061 in the Search field. Select the Documents tab, then select the Comment button in the list of documents. • <E T="03">Postal Mail/Commercial Delivery:</E> Send your comment to Docket No. APHIS-2022-0061, Regulatory Analysis and Development, PPD, APHIS, Station 2C-10.16, 4700 River Road, Unit 25, Riverdale, MD 20737-1238. Supporting documents and any comments that we receive on this docket may be viewed at <E T="03">regulations.gov</E> or in our reading room, which is located in room 1620 of the USDA South Building, 14th Street and Independence Avenue SW, Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799-7039 before coming. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Dr. Lydia Carpenter, Veterinary Medical Officer, Aquaculture, Swine, Equine, and Poultry Health Center, VS, Department of Agriculture, Animal and Plant Health Inspection Service, 920 Main Campus Drive, Suite 200, Raleigh, NC 27606; phone: (919) 855-7276; email; <E T="03">lydia.carpenter@usda.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Background</HD> Under Section 8310(d) of the Animal Health Protection Act (AHPA, 7 U.S.C. 8301 <E T="03">et seq.</E> ), the Secretary of Agriculture may cooperate with “State authorities, Indian tribe authorities, or other persons in the administration of regulations for the improvement of livestock and livestock products.” Under Section 8315 of the AHPA, the Secretary of Agriculture has the authority to issue orders and promulgate regulations relative to the provisions of the Act. The Secretary has delegated authority to issue such orders and regulations to the Animal and Plant Health Inspection Service (APHIS). Pursuant to this authority, APHIS may issue regulations to establish and administer livestock improvement plans. Currently, APHIS administers one livestock improvement program, the National Poultry Improvement Program (NPIP), which is described in 9 CFR parts 145, 146 and 147. NPIP is a collaborative effort involving industry, State, and Federal partners providing standards for certifying the health status of more than 99 percent of commercial poultry and egg operations across the United States. NPIP establishes general provisions for administering its program through Official State Agencies (OSAs); flock, hatchery, and dealer participation and management, including testing and inspection; and more specific provisions for managing different kinds of breeding and commercial flocks. The NPIP regulations also set forth auxiliary provisions for NPIP oversight through a General Conference Committee (henceforth “GCC” or “the Committee”), with direction on establishing membership, selecting and confirming delegates, and the Committee's role in preparing and recommending changes to the NPIP regulations. Specific blood testing, bacteriological and molecular examination, and flock sanitation processes are set forth in a series of Program Standards that the APHIS Veterinary Services (VS) Avian Health program, with the GCC's help, periodically updates and publishes for public notice and comment. No such program currently exists in the regulations for the swine industry. However, the industry has operated the US Swine Health Improvement Plan (US SHIP, the Plan), as a pilot program since 2020. The pilot program aims to certify participating sites as African swine fever (ASF)- and classical swine fever (CSF)-Monitored. ASF and CSF are highly contagious diseases of swine that can spread rapidly with high rates of morbidity and mortality. Neither disease is known to occur in the United States; introduction of either disease would result in significant disruptions to domestic and international trade. In order to participate in the pilot program, participating sites must meet biosecurity, traceability, and testing requirements and maintain documentation demonstrating such adherence. Participating sites with ASF and CSF certifications may market their products as such. A goal of the program is to mitigate possible disruptions to trade, both domestically and internationally, that could be caused by the introduction of these diseases into the United States. The pilot program is governed by a House of Delegates, which has met annually and is composed of representatives from academia and industry, and State and Federal animal health officials. These representatives are called “delegates” and are selected by the OSAs of the States they represent. At the House of Delegates meeting, the delegates consider and vote to recommend changes to the US SHIP program. Under the terms of this proposed rule, the House of Delegates would be led by a General Conference Committee (“GCC”), which would function as a Federal advisory committee to provide recommendations to APHIS relative to the administration of US SHIP. We discuss this at greater length later in this document. The proposed US SHIP regulations would incorporate the provisions of the pilot program and this governance structure with some modifications to meet Federal requirements, as discussed below. APHIS, the States, and the swine industry would jointly administer the codified program. Like the pilot program, participants would need to meet biosecurity, traceability, and testing requirements. Also like the pilot program, US SHIP would, at least initially, target ASF and CSF. APHIS plans to model US SHIP after NPIP, which is also a Federal-State-industry program. US SHIP would establish a similar platform for safeguarding, improving, and representing the health status of swine across participating farm sites, supply chains, States, and regions. As with the NPIP, OSAs would administer the program in their States by enrolling participants and conferring certification based on requirements such as disease testing and site biosecurity practices specific to the participating site type. Site types are described at greater length below and in the Program Standards that accompany this proposed rule. Site types include boar stud facilities, breeding herds, growing pig facilities, farrow to feeder/finisher facilities, small holding facilities, non-commercial facilities, live animal marketing operations, and slaughtering facilities. NPIP covers analogous site types in the poultry industry, such as hatcheries, dealers, and slaughtering facilities. Unlike NPIP, entities eligible to serve as OSAs would be limited to veterinary authorities responsible for enforcing a State's swine health regulations ( <E T="03">i.e.,</E> a State Animal Health Official) or a cooperative effort between a State Animal Health Official and other entities. In NPIP, the OSA may be any State Authority recognized by the U.S. Department of Agriculture (USDA, the Department), such as the State Departments of Agriculture, State Veterinary Diagnostic Laboratories, and State Poultry Associations. This modification for US SHIP reflects the critical need for a regulatory role in a program that monitors for diseases that are not currently known to exist in the United States. US SHIP would also include traceability provisions, which are not part of the NPIP, but which are necessary for ensuring the movement of healthy swine. Finally, APHIS would establish as part of US SHIP a GCC composed of swine producers and other industry and State animal health participants that would advise APHIS on matters of swine health and disease management. The US SHIP GCC would operate like the NPIP GCC, but with different Technical Committees organized around the issues impacting swine health. The group would provide technical and swine-specific support and advice to program participants as well as APHIS, acting as a liaison between the Agency and the swine industry. To codify US SHIP, we are proposing to add two new parts to the 9 CFR, parts 148 and 149. Part 148 would contain two subparts, one for general provisions of US SHIP (subpart A), and another for participating slaughtering facilities in US SHIP (subpart B). Part 149 would discuss the procedures for changing the regulations and Program Standards for US SHIP, and also contain provisions regarding US SHIP conferences and committees. Below, we discuss the provisions of US SHIP in the order in which they appear in ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 141k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━