89 FR 250 pgs. 107045-107063 - US Swine Health Improvement Plan

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Type: PRORULEVolume: 89Number: 250Pages: 107045 - 107063

Docket number: [Docket No. APHIS-2022-0061]

FR document: [FR Doc. 2024-31386 Filed 12-30-24; 8:45 am]

Agency: Agriculture Department

Sub Agency: Animal and Plant Health Inspection Service

Official PDF Version: PDF Version

Pages: 107045, 107046, 107047, 107048, 107049, 107050, 107051, 107052, 107053, 107054, 107055, 107056, 107057, 107058, 107059, 107060, 107061, 107062, 107063

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 148 and 149

[Docket No. APHIS-2022-0061]

RIN 0579-AE75

US Swine Health Improvement Plan

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Proposed rule.

SUMMARY:

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.

DATES:

We will consider all comments that we receive on or before January 30, 2025.

ADDRESSES:

You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to www.regulations.gov. Enter APHIS-2022-0061 in the Search field. Select the Documents tab, then select the Comment button in the list of documents.

• Postal Mail/Commercial Delivery: 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 regulations.gov 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.

FOR FURTHER INFORMATION CONTACT:

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; lydia.carpenter@usda.gov.

SUPPLEMENTARY INFORMATION:

Background

Under Section 8310(d) of the Animal Health Protection Act (AHPA, 7 U.S.C. 8301 et seq. ), 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.

[top] 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 ( i.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 the proposed regulations. We first discuss subpart A of part 148, then subpart B, then proposed part 149.

Proposed Part 148

Subpart A (General Provisions)

Subpart A of US SHIP, "General Provisions," would consist of proposed §§?148.1 through 148.11 and provide the general structure for participation in US SHIP.

Definitions (§?148.1)

Section 148.1 would contain definitions of the following terms used within proposed part 148: Administrator, African swine fever, Animal and Plant Health Inspection Service ( APHIS ), authorized agent, authorized laboratory, boar, boar stud, classical swine fever, Department, farrow to feeder/finisher facility, feral swine, gilt, growing pig facility, live animal marketing operation, National Animal Health Laboratory Network (NAHLN), non-commercial facility, Official State Agency, person, plan, pork product, Senior Coordinator, small holding facility, sow, State, swine, US SHIP Program Standards, and US SHIP Technical Committee.

We are proposing to define Administrator as "the Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator." This definition is drawn from NPIP and is generally consistent with the definition of the term within APHIS' regulations in 9 CFR chapter I.

We are proposing to define African swine fever as "a highly contagious viral hemorrhagic disease caused by a large, enveloped, double-stranded DNA virus of the family Asfarviridae and genus Asfivirus that affects animals in the family Suidae, including domestic pigs, feral swine, and Eurasian wild boar." This definition is derived from the World Organization for Animal Health (WOAH) technical disease card, ¹ APHIS Veterinary Services Center for Epidemiology and Animal Health (CEAH) case definition, ² and the Merriam-Webster dictionary. The APHIS Veterinary Services CEAH case definition was, in turn, developed by a group of APHIS interdisciplinary subject matter experts.

Footnotes:

¹ ?World Organization for Animal Health (June 2009). African Swine Fever. Technical Disease Cards. Retrieved September 6, 2024, from https://www.woah.org/app/uploads/2021/03/oie-african-swine-fever-technical-disease-card.pdf.

² ?APHIS (October 2023). African Swine Fever Response Plan: The Red Book. Retrieved September 6, 2024 from, https://aphis.stg.platform.usda.gov/sites/default/files/asf-responseplan.pdf.

We are proposing to define Animal and Plant Health Inspection Service (APHIS) as "the Animal and Plant Health Inspection Service of the U.S. Department of Agriculture." This definition is drawn from NPIP and is generally consistent with the definition of this term throughout APHIS' regulations in 9 CFR chapter I.

We are proposing to define authorized agent to mean any person designated under §?148.7 of the regulations to collect official samples for submission to an authorized laboratory in accordance with §?148.10 of the regulations. This definition is drawn from NPIP.

We are proposing to define authorized laboratory to mean a laboratory that meets the requirements of §?148.11 and is thus qualified to perform assays in accordance with the US SHIP regulations. This definition is likewise modeled on the definition of authorized laboratory within NPIP.

We are proposing to define boar as "a sexually intact male swine." This definition, along with the definitions of the terms gilt, sow, swine, and pork product, are derived from USDA's Agricultural Marketing Service's (AMS') regulations in 7 CFR 59.200. That section of AMS' regulations contains definitions of types of swine and pork products that must be reported under AMS' administration of the Agricultural Marketing Act of 1946 (7 U.S.C. 1635-1636i). Because of these mandatory requirements, we consider swine producers to be familiar with AMS' definitions, and also find them appropriate for the purposes of our proposed US SHIP regulations, which would establish a voluntary program to promote marketing of swine and pork products.

We are proposing to define boar stud as "a swine production site with mature boars that distributes semen to other swine production sites." This definition is taken from the US SHIP pilot program enrollment documents, which were created by the industry, academia, and regulatory experts that worked to develop the pilot program. An interdisciplinary group of APHIS Veterinary Services subject matter experts contributed to the definitions developed for the pilot program.

[top] We would define classical swine fever as "a highly contagious viral septicemia, caused by a small, enveloped RNA virus of the family Flaviviridae and genus Pestivirus, that affects animals in the family Suidae, including domestic pigs, feral swine, and Eurasian wild boar." This definition is derived from the WOAH technical disease card, the APHIS Veterinary Services CEAH case

definition, and the Merriam-Webster dictionary. The APHIS Veterinary Services CEAH case definition was, in turn, developed by a group of interdisciplinary subject matter experts.

We are proposing to define Department to mean the U.S. Department of Agriculture.

We are proposing to define farrow to feeder/finisher facility as "a swine production site with breeding females (gilts and/or sows) and grow feeder swine for purposes other than breeding stock replacement for this particular farm site, and that houses =1,000 breeder or feeder swine." This definition is taken from the US SHIP pilot program enrollment documents, which were created by the industry, academia, and regulatory experts that worked to develop the pilot program. An interdisciplinary group of APHIS Veterinary Services subject matter experts contributed to the definitions developed for the pilot program.

We are proposing to define feral swine as "free-roaming swine." This definition is taken from part of the definition of feral swine in 9 CFR 78.1. That section of part 78 contains definitions used within our regulations governing APHIS' domestic brucellosis program. The definition of feral swine in the US SHIP regulations, however, would omit additional provisions within that definition that pertain to swine brucellosis, as that disease is not currently covered by US SHIP.

We are proposing to define gilt as "a young female swine that has not produced a litter." The definition is derived from AMS' regulations in 7 CFR 59.200.

We are proposing to define growing pig facility as "a swine production site with =1,000 feeder swine (nursery, grower, or finisher)." This definition is taken from the US SHIP pilot program enrollment documents, which were created by the industry, academia, and regulatory experts that worked to develop the pilot program. An interdisciplinary group of APHIS Veterinary Services subject matter experts contributed to the definitions developed for the pilot program.

We are proposing to define Live animal market operation as "A dealer with a livestock yard/buying facility that markets swine for resale of such swine to slaughter facilities."

We are proposing to define the National Animal Health Laboratory Network (NAHLN) as "a nationally coordinated network and partnership of primarily Federal, State, and university-associated animal health laboratories that provide animal health diagnostic testing, methods research and development, and expertise for education and extension to detect biological threats to the nation's animal agriculture, thus protecting animal health, public health, and the nation's food supply." This definition is taken from 9 CFR 71.1, which contains definitions of, among other things, APHIS' regulations governing the approval of laboratories to conduct official testing. Approved laboratories must use APHIS-approved assay methods. As discussed further below, the laboratories that conduct official testing within US SHIP would have to belong to the NAHLN.

We are proposing to define non-commercial facility as "a swine production site with <100 breeding females (gilts, boars, and/or sows) or feeder swine. Backyard, exhibition, or niche swine production sites are considered non-commercial facilities if they maintain fewer than 100 breeding swine or feeder swine." This definition is taken from the US SHIP pilot program enrollment documents, which were created by the industry, academia, and regulatory experts that worked to develop the pilot program. An interdisciplinary group of APHIS Veterinary Services subject matter experts contributed to the definitions developed for the pilot program.

We are proposing to define Official State Agency as "the State veterinary authority recognized by the Department to cooperate in the administration of the Plan." This definition is drawn from NPIP, and OSAs would play a functionally equivalent role within US SHIP to that which they play within NPIP. We discuss this at greater length later in this proposed rule.

We are proposing to define person as "a natural person, firm, or corporation." This definition is drawn from NPIP, and, as within NPIP, we would use person in both an individual and a corporate sense within US SHIP.

We are proposing to define Plan to mean the provisions of the US SHIP contained in part 148. This definition is derived from NPIP, where the term is used equivalently.

We are proposing to define pork product as "a product or byproduct produced or processed in whole or in part from swine." This definition is derived from AMS' regulations in 7 CFR 59.200.

We are proposing to define Senior Coordinator to mean an employee of APHIS whose duties may include, but will not necessarily be limited to:

• Serving as Executive Secretary of the GCC;

• Serving as chairperson of the House of Delegates conference;

• Coordinating the State administration of US SHIP through periodic reviews of the administrative procedures of OSAs, according to the applicable provisions of the Plan and the Memorandum of Understanding; and

• Coordinating future rulemakings to incorporate the proposed changes of the provisions adopted at the House of Delegates meeting into the regulations in parts 148 and 149.

This definition is drawn from NPIP, in which the Senior Coordinator fulfills a similar role.

We are proposing to define small holding facility as "a swine production site with =100 and <1,000 breeding swine (gilts, boars, and/or sows) or feeder swine." This definition is taken from the US SHIP pilot program enrollment documents, which were created by the industry, academia, and regulatory experts that worked to develop the pilot program. An interdisciplinary group of APHIS Veterinary Services subject matter experts reviewed the definitions developed for the pilot program.

We are proposing to define sow as "an adult female swine that has produced 1 or more litters." The definition is derived from AMS' regulations in 7 CFR 59.200.

We are proposing to define State as "any State, the District of Columbia, or Puerto Rico." This definition is drawn from NPIP. We acknowledge that the definition of State within the AHPA itself is more expansive, and also includes all other territories or possessions of the United States. However, as with NPIP, the sole participating territory or possession in US SHIP is Puerto Rico, and no other territories or possessions are expected to participate.

We are proposing to define swine as "a porcine animal raised to be a feeder pig, raised for seedstock, raised for exhibition, or raised for slaughter." This definition is derived from AMS' regulations in 7 CFR 59.200.

[top] We are proposing to define US SHIP Program Standards as "a document that contains biosecurity, traceability, and sampling and testing procedures approved by the Administrator for use under parts 148 and 149. This document may be obtained from the US SHIP website at (address to be added in final rule) or by writing to APHIS at US Swine Health Improvement Plan (US SHIP), APHIS, USDA, 920 Main Campus Drive, Suite 200, Raleigh, NC 27606." This definition is modeled after NPIP with changes to reflect the contact information for US SHIP.

We are proposing to define US SHIP Technical Committee as "a committee made up of technical experts on swine health, including topics such as biosecurity, traceability, and sampling and testing. The committee consists of representatives from the swine and pork products industries, universities, and State and Federal governments that are appointed by the Senior Coordinator and reviewed by the General Conference Committee. The committee will consider proposed changes to the Provisions and Program Standards of the Plan and provide recommendations to the House of Delegates as to whether they are scientifically or technically sound." This definition is derived from NPIP with modifications to fit the specific characteristics of US SHIP.

Administration (§?148.2)

Proposed §?148.2 would outline the administration of US SHIP, including the respective roles of APHIS, the OSAs, and authorized laboratories. These provisions are modeled on similar provisions in NPIP, with some changes to reflect the specific needs of US SHIP.

Proposed §?148.2(a) would provide that the Department will cooperate through a Memorandum of Understanding (MOU) with OSAs in the administration of the Plan. It also would require OSAs to designate a contact representative to serve as a liaison between APHIS and the OSAs. These provisions are modeled on similar provisions within NPIP. As in NPIP, APHIS would coordinate extensively with OSAs in the administration of the program, and the MOU and designated liaison would facilitate that interaction.

Proposed §?148.2(b) would provide that the administrative procedures, decisions, and records of the OSA relevant to the implementation of US SHIP are subject to review by APHIS. This provision is modeled on similar provisions within NPIP.

State administrative procedures, decisions, and records would only be subject to review by APHIS as they pertain to the implementation of US SHIP. Proposed paragraph (b) of §?148.2 would provide further that the OSA shall carry out the administration of the Plan within the State according to the applicable provisions of the Plan and the MOU. This provision is directly modeled on NPIP, in which the NPIP regulations and the MOU serve as the framework to guide the OSA's actions.

Proposed §?148.2(c) would provide that the OSA of any State may adopt regulations applicable to the administration of the Plan in such State further defining the provisions of the Plan or establishing higher standards compatible with the Plan. This provision is modeled after NPIP and allows States to further delineate or augment administration of the Plan within the general framework provided by the regulations themselves and the MOU.

Proposed §?148.2(d) would provide that laboratories authorized in accordance with proposed §?148.11 will conduct diagnostic testing when determining the status of a participating herd with respect to official Plan classifications. Section 148.11 would contain requirements for laboratories to be authorized to conduct official testing within US SHIP. This provision is modeled on similar provisions in §?145.2 of the NPIP regulations; however, as discussed at greater length below, while laboratories do not have to belong to the NAHLN to conduct testing within the NPIP, they would within US SHIP.

Participation (§?148.3)

Proposed §?148.3 would outline rules for participation in US SHIP. These rules are modeled after similar provisions in NPIP, with some changes to reflect the specific needs of US SHIP. These provisions also draw on the US SHIP pilot program.

Proposed paragraph §?148.3(a) would provide that US SHIP is a cooperative Federal-State-Industry program aimed at preventing and monitoring specific diseases in swine. This provision is modeled after NPIP. The paragraph also outlines the kinds of entities that can participate in US SHIP, which would 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 that meet Plan standards in biosecurity, traceability, and surveillance for designated diseases and are in States with an APHIS-recognized OSA. This list of entities that may participate in US SHIP is drawn from the US SHIP pilot program's Enrollment Form. ³ This list is also modeled after similar provisions in NPIP, but with changes to reflect the terminology used in, and structure of, the U.S. swine industry.

Footnotes:

³ ?US SHIP Pilot Program (2024). Enrollment Forms. U.S. Swine Health Improvement Plan. Retrieved September 6, 2024, from https://usswinehealthimprovementplan.com/program-documents/enrollment-documents/.

Proposed §?148.3(a) also would provide that certifications would require participants to meet Plan standards in biosecurity, traceability, and surveillance for designated diseases. These standards are drawn from the US SHIP pilot program.

Proposed §?148.3(b) would outline prerequisites for participation in the plan. Potential participants would have to demonstrate to their OSA that their facilities, personnel, and practices are adequate for carrying out the applicable requirements of the Plan. Participants would also have to sign an agreement with the OSA to comply with the Plan's provisions and any regulations of the OSA under §?148.2. This provision is modeled on NPIP.

Proposed §?148.3(c) would define the timeframe of participation in US SHIP. Participants would have to comply with the requirements of the program until released by the OSA. This provision is modeled on NPIP.

Proposed §?148.3(d) would provide that participants may enroll with any swine operations within each participating State or slaughter facilities within each participating State, and it would list the information that participants would have to report to their OSA upon enrolling. The US SHIP pilot program's Enrollment Form requires participants to submit the same information listed here, and the information on the Enrollment Form was modeled on the information requirements to participate in NPIP. ⁴

Footnotes:

⁴ ?US SHIP Pilot Program (2024). Enrollment Forms. U.S. Swine Health Improvement Plan. Retrieved September 6, 2024, from https://usswinehealthimprovementplan.com/program-documents/enrollment-documents/.

Proposed §?148.3(d)(1) would require participants to submit the name, address, and contact information for the US SHIP participant, which will be the swine owner or owner of the slaughtering facility.

Proposed §?148.3(d)(2) would require participants to submit the address (including latitude and longitude, if a 911 address is not available for the site) of animal location, and name and contact information for the premises (site) owner.

[top] Proposed §?148.3(d)(3) would require participants to submit the premises identification number (PIN) for the site and common name of site. This provision is modeled on NPIP, which requires participants to use a number assigned by APHIS. NPIP did not require the use of a PIN, as such a system had not yet been established when the NPIP regulations were initially drafted. The requirement that participants use their existing PIN is, therefore, unique to US SHIP, and is drawn from the US SHIP pilot program. For purposes of US SHIP, we would recognize existing PINs. All participating sites will be assigned a PIN

when they join, should they not already have one, so this requirement will not impose additional burdens on participants. PINs are widely used in the swine industry and, based on the pilot program, we anticipate that many sites will already have PINs before they begin participating in US SHIP.

Proposed §?148.3(d)(4) would require participants to submit premises type, including 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. These premise types are taken directly from the US SHIP pilot program's Enrollment Form.

Proposed §?148.3(d)(5) would require participants to submit expected site capacity unless the site is a slaughtering facility. This provision is again drawn from the US SHIP Enrollment Form. We discuss later in this document the parallel information that would be required for participating slaughtering facilities.

Proposed §?148.3(d)(6) would require participants to submit the name and contact information of the individual who is attesting to their understanding and intent to comply with the regulations and relevant US SHIP Program Standards. This requirement is drawn from the pilot program's US SHIP Enrollment Form.

Finally, proposed §?148.3(d)(7) would require the aforementioned individual's acknowledgement that they understand and intend to comply with the regulations and relevant US SHIP Program Standards and the date of their acknowledgement.

Proposed §?148.3(e) provides that participants may qualify solely for ASF and CSF Monitored certification. In other words, the OSA cannot compel participation in any other classifications for US SHIP outlined in §?148.10. This provision is modeled on similar provisions within NPIP.

We acknowledge that, at least initially, there will only be one program certification within US SHIP. However, as additional certifications are added over time, participants may exercise the option to participate in those additional certifications. All US SHIP participants would have to participate in the ASF/CSF Monitored certification in order to participate in the additional certifications.

Proposed §?148.3(f) would allow participants to use the official US SHIP emblem. It would also provide a link to a website that will display the official US SHIP emblem that may be used by participants. Additionally, it would describe the procedure for revising the emblem through publication of notices in the Federal Register . The use of participation emblems within US SHIP is modeled on similar provisions within NPIP. However, NPIP reproduces the emblems in the regulatory text of the NPIP regulations themselves, rather than web-lists the emblems.

Using a link to a website instead of reproducing the emblem in the regulations would allow us to revise the emblem through a notice-based process, rather than through rulemaking. In the notice-based process, if APHIS proposes to revise the Plan emblem, we would publish a notice in the Federal Register making available the revised emblem, as well as the basis for the revisions, and requesting public comment. If no comments are received on the notice, or if the comments received do not call into question the basis for the revisions, we would publish a subsequent notice in the Federal Register responding to the comments received and announcing the revised emblem. If comments identify concerns regarding the basis for the proposed revisions, however, APHIS would not take any action to revise the emblem until first addressing those concerns as appropriate.

General Provisions for All Participants (§?148.4)

Proposed §?148.4 outlines provisions for all participants. As with other sections of the proposed regulations, these provisions are modeled after similar provisions in NPIP, with some changes to reflect the specific needs of US SHIP.

Proposed §?148.4(a) would provide that participants must retain records necessary for demonstrating compliance with certification requirements. This provision is modeled on NPIP and the pilot program for US SHIP, and, as noted previously in this document, participant retention of records is necessary to demonstrate compliance and eligibility to participate in the Plan.

Proposed §?148.4(b) would provide that a participant's animals, animal products, and records as needed to confirm certification requirements of swine or pork products, as well as advertising materials, are subject to inspection by the OSA or APHIS at any time, in accordance with §?148.8(b) and any additional requirements by the Official State Agency. This provision is also modeled on NPIP.

Proposed §?148.4(c) would provide that advertising by Plan participants must comply with the Plan itself, as well as applicable rules of the OSA and the Federal Trade Commission. This provision is likewise modeled after NPIP. The paragraph also provides that if a participant advertises swine or pork products as belonging to one of the Plan's official classifications, the participant may only include references to associated or franchised facilities if those facilities produce swine or pork products carrying the same official classification. This provision is modeled after NPIP and ensures that marketing within US SHIP clearly differentiates facilities that are part of US SHIP from those that are not.

Proposed §?148.4(d) would provide that PINs will be used to verify participation in US SHIP, and that previously existing PINs will be recognized for this purpose. Only participants who do not have a PIN will receive a new one. The requirement that participants have some kind of identifying number is drawn from NPIP. However, NPIP does not require the use of a PIN. Instead, NPIP requires APHIS to assign participants approval numbers. The requirement that participants use the PIN is drawn from the US SHIP pilot Program Standards. The US SHIP pilot program uses the PIN for identification purposes because most potential participants already have a PIN, which is widely used in the swine industry, and it is more efficient to use the existing PIN system rather than assigning new identifying numbers to participants.

Terminology and Classification; General (§?148.5)

Proposed §?148.5 would outline general terminology and classification within US SHIP. As with other provisions of US SHIP, these are modeled after similar provisions in NPIP, with some changes to reflect the specific needs of US SHIP.

Proposed §?148.5(a) would provide that participants may only use the classification terms listed in proposed §?148.6 and their respective emblems to describe swine or pork products that have met all the specific requirements of such classifications. This provision is modeled after NPIP and ensures that products marketed as having met a particular classification have, in fact, done so.

[top] Proposed §?148.5(b) would provide that swine or pork products carrying Plan classification shall lose their identity under the Plan if they are purchased for resale by, or consigned to, non-participants. This provision is modeled after NPIP and helps ensure that swine and products marketed as having met a particular classification were continually maintained under the classification's requirements.

Terminology and Classification; Herds, Products, and States (148.6)

Proposed §?148.6 would outline terminology and classifications for herds, products, and States within US SHIP.

Proposed §?148.6(a) would provide that participating swine operations and products that have met any of the terms or classifications specified in the section may be designated with the corresponding emblem for the term or the classification, and the paragraph provides the web address where all such emblems are located. This provision is modeled after similar provisions in NPIP.

The paragraph also would describe APHIS' procedure for modifying the emblems for various terms or classifications provided in the section. As with the process for modifying the emblem for participation in US SHIP itself, APHIS would announce these changes through a notice published in the Federal Register with a public comment period. If we propose to revise an emblem, we would publish a notice in the Federal Register making available the revised emblem, as well as the basis for the revision, and requesting public comment. If no comments are received on the notice, or if the comments received do not call into question the basis for the revisions, we would publish a subsequent notice in the Federal Register responding to the comments received and announcing the revised emblem. If comments identify concerns regarding the basis for the proposed revisions, however, APHIS would take no action to revise the emblem until addressing those concerns as appropriate.

Proposed §?148.6(b) would outline the ASF-CSF Monitored certification and the requirements for participants to receive the certification. This certification is modeled after the certifications for various poultry diseases covered by NPIP. The specific requirements of the ASF-CSF Monitored certification draw on the requirements for ASF-CSF Monitored certification within the US SHIP pilot program.

Proposed §?148.6(b)(1) would require that participating swine operations only introduce herd additions that have either been exclusively sourced from certified ASF-CSF Monitored sites or sites that have participated in testing and clinical observation of their herds sufficient to demonstrate freedom from ASF and CSF.

The US SHIP pilot program did not include any requirements for additions of new swine to certified sites. This addition is necessary, however, because this requirement would further help prevent introduction of disease to herds certified as ASF-CSF Monitored and ensure that swine on certified sites are held to and recognized as a different status than swine on non-certified sites.

Proposed §?148.6(b)(2) would require the swine operation to collect samples and submit them for testing for any disease incident or death loss of participating swine that is suggestive of ASF or CSF. Testing would have to be conducted through the USDA Swine Hemorrhagic Fevers Surveillance Plan or a foreign animal disease investigation at a laboratory authorized in accordance with proposed §?148.11, and using tests approved by the Administrator to detect the presence of ASF and CSF. The US SHIP Program Standards document states that participants should submit ASF/CSF NAHLN-approved sample types ( https://www.aphis.usda.gov/sites/default/files/nahln-sample-chart-regulatory-submitters.pdf ) to a NAHLN laboratory approved by APHIS to conduct test(s) for the disease(s) of concern. Authorized laboratories must follow NAHLN Standard Operating Procedures (SOPs) to conduct the requested testing. Further information regarding the USDA Swine Hemorrhagic Fevers Surveillance Plan is provided at https://aphis.usda.gov/sites/default/files/hemorrhagic-fevers-integrated-surveillance-plan.pdf.

NPIP requires similar testing following disease incidents. However, the requirement to use only NAHLN laboratories would be unique to US SHIP and is taken from the US SHIP pilot Program Standards document. For reasons discussed below in our discussion of proposed §?148.11, only NAHLN laboratories have the necessary equipment and expertise to perform the required tests for ASF and CSF in swine.

Proposed §?148.6(b)(3) would require participants to demonstrate competency in tracking all swine movements onto and off of certified sites, as described in the Program Standards. This requirement would ensure that swine and pork products could be traced to their farm of origin.

Proposed §?148.6(b)(4) would require biosecurity to be maintained in a manner approved by APHIS and evaluated against these standards by the OSA. The paragraph also provides that approved biosecurity procedures will be listed in the US SHIP Program Standards. The Program Standards address biosecurity procedures such as Plan requirements, downtime and personal protective equipment requirements, and requirements in the event of an ASF/CSF incursion.

Changes to the US SHIP Program Standards would be made in accordance with §?149.9, as described later in this proposed rule.

Finally, currently, US SHIP includes a classification for ASF and CSF. However, we are open to including additional programs and classifications. We ask for input on what additional programs and classifications might be beneficial within US SHIP. As noted previously, if additional programs and classifications are established, producers could elect whether or not to participate in them but would have to participate in the ASF-CSF Monitored program as a condition of participation in those programs.

Supervision (§?148.7)

Proposed §?148.7 would discuss supervision of the Plan.

Proposed §?148.7(a) would provide that the OSA may designate qualified persons as authorized agents to collect samples for diagnostic testing as required by §?148.10. This provision is modeled after a similar provision in §?145.11 of the NPIP regulations.

Proposed §?148.7(b) would provide that the OSA shall employ or authorize qualified persons as State inspectors to verify compliance with the Plan. This provision is likewise modeled after NPIP.

Proposed §?148.7(c) would provide that the authorities to collect samples or verify program compliance issued under the provisions of this section that are designated by the OSA are subject to cancelation by the OSA or by APHIS on the following grounds: Incompetence, failure to comply with provisions of the Plan, or failure to comply with APHIS or OSA regulations.

This provision is modeled on similar provisions within NPIP. However, NPIP only allows the OSA to cancel the authorities outlined in the regulations but does not grant such an allowance to APHIS. However, US SHIP covers diseases ASF and CSF, which are Foreign Animal Diseases (FADs), that is, diseases that are not known to exist in the United States. The control of such diseases is a Federal responsibility, therefore, in US SHIP, APHIS must also have the power to cancel the authorities outlined in this section.

[top] The paragraph also would provide that canceling the authorities to collect samples or verify program compliance that have been previously granted by the OSA may only be taken following an investigation by the OSA or APHIS and after the authorized person has been notified of the action and given the

opportunity to present their views. This provision is modeled on similar provisions in §?145.11 of the NPIP regulations; however, unlike NPIP, we would allow for cancellation of authority for violation not only of OSA regulations but also APHIS regulations. Again, the diseases covered by US SHIP (ASF and CSF) are FADs, and therefore subject to Federal authorities. For that reason, failure to follow APHIS or OSA regulations regarding such diseases could have significant consequences for domestic producers, and we thus consider it necessary to revoke authorization based on failure to adhere to these regulations. Additionally, and for a similar reason, whereas the NPIP regulations require investigations relative to cancellation to be conducted by the OSA, we would allow either the OSA or APHIS to conduct the investigation.

Maintenance of Certification (§?148.8)

Proposed §?148.8 would discuss maintenance of certification within US SHIP. Proposed §?148.8(a) would provide that the OSA would verify whether each certified participant continues to meet the requirements to maintain certification at least one time annually, or more if determined appropriate for purposes of determining Plan compliance. This provision is modeled on a similar provision in NPIP for hatcheries that participate in NPIP and is necessary in order to ensure that facilities continually adhere to the requirements of the Plan.

Proposed §?148.8(b) would require all records supporting continued program participation to be able to be made available to a State inspector for annual review. This provision is modeled on similar NPIP provisions. However, whereas the NPIP provisions reference specific forms that must be used for the records, the US SHIP regulations would not contain such requirements. This would allow greater latitude to APHIS and producers to develop mechanisms for recordkeeping that can be used to meet the requirements of the regulations, without having to update the regulations each time a new mechanism is identified. The paragraph also requires each OSA to maintain enrollment records for 5 years and inspection records for at least 3 years from the date of inspection. We are proposing that the OSA would have to maintain initial enrollment records for 5 years because these records are foundational in documenting the OSA's decision to allow the facility to participate in US SHIP.

The paragraph also would allow OSAs to arrange on-site inspections of herds and premises by its representatives or a designee if the State inspector has reasonable basis to believe that a breach of biosecurity, specimen testing, or other provision may have occurred for Plan programs for which the herds have qualified. This provision is modeled after NPIP with some changes in terminology to reflect the kind of testing used in US SHIP.

Proposed §?148.8(c) would allow APHIS to conduct on-site inspections of participating swine herds and premises if it has reasonable basis to believe that a breach of the Plan's provisions may have occurred. NPIP only allows the OSA to conduct such inspections, not APHIS. However, because of the nature of the diseases covered by US SHIP, we believe it is also necessary to retain the ability of APHIS to investigate herds and premises, if warranted. If OSAs initiate investigations, they will provide APHIS with a summary of the compliance concerns that were investigated and supporting evidence, along with their recommended outcomes for resolutions. APHIS will determine whether to accept those outcomes or pursue further action.

Debarment From Participation (§?148.9)

Proposed §?148.9 would discuss debarment from participation in the Plan. These rules are modeled after similar provisions in NPIP with some changes to reflect the specific needs of US SHIP. In particular, US SHIP grants powers to APHIS and the OSA, which are only granted to the OSA in NPIP. This change is needed because the diseases covered by US SHIP are FADs. The introduction of such diseases into the United States has potentially severe economic implications, therefore APHIS has additional responsibilities for controlling these kinds of diseases.

The section would provide that, following an investigation by the OSA, its representative, or by APHIS, APHIS will notify participants in writing of their compliance or noncompliance with Plan provisions or with regulations of the OSA or APHIS. In the event of a finding of noncompliance, the notification would articulate that APHIS may debar the participant from further participation in US SHIP if the noncompliance concerns are not addressed, and would afford the participant time of at least 30 days to demonstrate or achieve compliance.

The section also would state that if the participant does not demonstrate or achieve compliance within the specified time period, APHIS may debar the participant from the Plan until the participant can demonstrate compliance with the plan.

The section also would provide that the debarred participant will be given written notice of the bases for the debarment and must be given an opportunity to present their views in accordance with procedures adopted by APHIS. Following the participant's statement, APHIS would decide whether the debarment will continue. All of these provisions are taken from NPIP, but with the relevant authorities granted to APHIS, instead of just to the OSA, as is the case in NPIP.

The paragraph also would provide that APHIS' decision will be final unless the debarred participant requests the Administrator to review the eligibility of the debarred participant for continued participation within 30 days from the issuance of the written notice of debarment. The request for review would have to state all facts and reasons upon which the participant relies to consider the debarment to be in error. As promptly as circumstances allow, the Administrator would respond in writing to uphold or reverse the debarment.

Testing (§?148.10)

Proposed §?148.10 discusses testing within US SHIP. The section is modeled after similar provisions in NPIP, with some changes to reflect the specific needs of US SHIP. The section provides that samples shall be collected by an authorized agent or State or Federal inspector and tested by a laboratory authorized in accordance with proposed §?148.11. This provision is modeled after NPIP. Additionally, as in NPIP, the Program Standards document would be used to describe the testing procedures.

Authorized Laboratories (§?148.11)

[top] Proposed §?148.11 would outline requirements for authorized laboratories. These proposed requirements are modeled after similar provisions in NPIP, with some changes to reflect the specific needs of US SHIP. The section would provide that in order to be authorized to conduct testing, laboratories must be approved by APHIS in accordance with 9 CFR 71.22 and must be NAHLN laboratories approved as proficient in the assays for diseases specified by US SHIP. This provision is modeled on NPIP. However, NPIP does not require laboratories to belong to the NAHLN in order to be authorized to conduct testing within NPIP. This is because the diseases of poultry covered by NPIP are often not FADs, and testing for them may be conducted at laboratories without specific proficiency in FADs. However, ASF and CSF are FADs, and only certain laboratories within the NAHLN have both the assays and the requisite proficiency in their

usage to test for these diseases. Accordingly, even within the US SHIP pilot program, all testing for ASF and CSF has been conducted at NAHLN laboratories.

The paragraph also requires authorized laboratories to follow the NAHLN guidance document for reporting diseases specified as part of US SHIP directly to APHIS. Because all the laboratories used in US SHIP will be NAHLN laboratories, US SHIP does not need to outline additional reporting procedures within the regulations and can instead refer parties to the relevant procedures and processes in the NAHLN guidance document.

Subpart B (Special Provisions for Slaughtering Facilities)

Subpart B of US SHIP, "Special Provisions for Slaughtering Facilities," would consist of proposed §§?148.21 through 148.23 and contain provisions for slaughtering facilities to participate in US SHIP. As with other sections of the proposed regulations, these provisions are modeled after similar provisions in NPIP, with some changes to reflect the specific needs of US SHIP.

Definition (§?148.21)

Proposed §?148.21 lists definitions relevant to the subpart. We are proposing to define slaughtering facility as "a slaughter plant processing swine that is Federally inspected or under State inspection that the US Department of Agriculture's Food Safety Inspection Service has recognized as equivalent to Federal inspection." This definition is drawn from the definition of the term meat-type chicken slaughter plant within §?146.31 of the NPIP regulations, with appropriate modifications to reflect the nature of the swine industry.

Participation (§?148.22)

Proposed §?148.22(a) would require participating slaughter facilities to comply with the general provisions of §?148.4 of the regulations as well as the slaughter facility-specific provisions of subpart B.

Proposed §?148.22(b) would require participating slaughter facilities to supply the information outlined in §?148.3(d), which is also required of all other Plan participants, with one exception. Instead of providing expected site capacity (number of breeding swine and/or growing pigs), as required by §?148.3(d)(5), slaughtering facilities should provide expected slaughter capacity (number of swine slaughtered daily/weekly).

Terminology and Classification; Slaughtering Facilities (§?148.23)

Proposed §?148.23 discusses terminology and classification for slaughtering facilities within US SHIP.

Proposed §?148.23(a) would provide that participating slaughtering facilities may use designs illustrated at an APHIS website listed in the regulations if they have complied with the requirements specified in §?148.23. This provision is modeled on NPIP. However, NPIP reproduces the designs in the regulations. As in subpart A, we would not include the designs in the regulations so that we may propose to update them using notices published in the Federal Register . The notice-based process for updating the designs for various classifications would be identical to that articulated in proposed subpart A for updating the designs for the classifications listed in that subpart.

Proposed §?148.23(b) would outline the ASF-CSF certification requirements for slaughter facilities, which include maintaining animal and product segregation. This certification is modeled after the certifications for various poultry diseases covered by NPIP. The specific requirements of the ASF-CSF monitored certification draw on the US SHIP pilot Program Standards document.

Proposed §?148.23(b)(1) would require slaughter participants to have the capability to separate ASF-CSF monitored slaughter swine from swine and pork products from source farms not certified in the Plan in a manner satisfactory to the OSA. This provision is based on provisions of the pilot program, which is modeled after analogous provisions in NPIP.

Proposed §?148.23(b)(2) requires participants to report disease events with clinical signs compatible with ASF-CSF, including ante- or post-mortem indicators of possible hemorrhagic disease, for surveillance testing. Compatible clinical signs are listed in the US SHIP Program Standards. This provision is based on provisions of the pilot program, which is modeled after analogous provisions in NPIP.

Part 149 Procedures for Changing US SHIP Provisions

Proposed part 149, consisting of §§?149.1 through 149.9, outlines the procedures for changing the provisions of US SHIP. As with other sections of the proposed regulations, these provisions are modeled after similar provisions in NPIP, with some changes to reflect the specific needs of US SHIP. However, while most provisions in US SHIP are not only modeled after similar provisions of NPIP, but also based on provisions in the US SHIP pilot program, this is not true of many of the provisions in part 149. This is because the pilot program operates as an industry-led endeavor under the auspices of an independent overseer, whereas the codified US SHIP regulations would be an APHIS-administered program in which an industry-led advisory committee would advance policy recommendations for incorporation into the US SHIP regulations.

To that end, if this proposed rule is finalized and US SHIP regulations are issued, APHIS intends to establish an advisory committee pursuant to the Federal Advisory Committee Act (5 USC. 10, FACA) to serve as the GCC for US SHIP. Our current thinking is that the GCC would best function as an independent FACA committee operating under a charter rather than as a subcommittee within one of USDA's existing FACA committees; however, we request specific public comment on this matter.

Definitions (§?149.1)

Proposed §?149.1 lists definitions relevant to part 149. We are proposing to define Administrator as "the Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator." This definition is drawn from NPIP and is generally consistent with the definition of the term within APHIS' regulations in 9 CFR chapter I.

We are proposing to define Animal and Plant Health Inspection Service (APHIS) as "the Animal and Plant Health Inspection Service of the US Department of Agriculture." This definition is drawn from NPIP and is generally consistent with the definition of this term throughout APHIS' regulations in 9 CFR chapter I.

We are proposing to define Department as "the US Department of Agriculture." This definition is taken directly from NPIP.

[top] We are proposing to define House of Delegates as "a decision-making body composed of US swine industry participants and subject matter experts that aim to represent the interests of swine industry stakeholders across each of the participating States. The House of Delegates meets at regular intervals for the purpose of sharing research and outcomes from program-related initiatives, reviewing and voting on proposed program changes, and formally facilitating the program's development." This definition is drawn from the US SHIP pilot program.

We are proposing to define non-commercial facility as "a swine production site with <100 breeding swine (gilts, boars, and/or sows) or feeder swine. Backyard, exhibition, or niche swine production sites are considered non-commercial facilities if they maintain fewer than 100 breeding swine or feeder swine." This definition is taken from the US SHIP pilot program enrollment documents, which were created by the industry, academia, and regulatory experts that worked to develop the pilot program. An interdisciplinary group of APHIS Veterinary Services subject matter experts contributed to the definitions developed for the pilot program.

We are proposing to define Official State Agency as "the State veterinary authority recognized by the Department to cooperate in the administration of the Plan." This definition is drawn from NPIP, and as noted throughout this document, OSAs would play a functionally equivalent role within US SHIP to that which they play within NPIP.

We are proposing to define Plan to mean the provisions of the US Swine Health Improvement Plan contained in part 149. This definition is derived from NPIP, where the term is used equivalently.

We are proposing to define Senior Coordinator to mean an employee of APHIS whose duties may include, but will not necessarily be limited to:

• Serving as Executive Secretary of the GCC;

• Serving as chairperson of the House of Delegates conference;

• Coordinating future rulemakings to incorporate the proposed changes of the provisions adopted at the House of Delegates meeting into the regulations in parts 148 and 149.

This definition is drawn from NPIP, in which the Senior Coordinator fulfills a similar role.

We are proposing to define slaughtering facility as "a slaughter plant processing swine that is Federally inspected or under State inspection that the U.S. Department of Agriculture's Food Safety Inspection Service has recognized as equivalent to Federal inspection." This definition is drawn from the definition of the term meat-type chicken slaughter plant within §?146.31 of the NPIP regulations, with appropriate modifications to reflect the nature of the swine industry.

We are proposing to define State as "any State, the District of Columbia, or Puerto Rico." This definition is drawn from NPIP. We acknowledge that the definition of State within the AHPA itself is more expansive, and also includes all other territories or possessions of the United States. However, as within NPIP, the sole participating territory or possession in US SHIP is Puerto Rico, and no other territories or possessions are expected to participate.

We are proposing to define swine as "a porcine animal raised to be a feeder pig, raised for seedstock, raised for exhibition, or raised for slaughter." As noted previously, this definition is derived from AMS' regulations in 7 CFR 59.200.

We are proposing to define US SHIP Program Standards as "a document that contains biosecurity, traceability, and sampling and testing procedures approved by the Administrator for use under parts 148 and 149. This document may be obtained from the US SHIP website at (address to be added in final rule) or by writing to APHIS at U.S. Swine Health Improvement Plan, APHIS, USDA, 920 Main Campus Drive, Suite 200, Raleigh, NC 27606." This definition is modeled after NPIP with changes to reflect the contact information for US SHIP.

General (§?149.2)

Section 149.2 would provide that changes to the US SHIP regulations will be proposed according to the procedures outlined in proposed part 149, provided that the Department reserves the right to make changes without observance of these procedures when such action is deemed necessary in the public interest. This provision is drawn from NPIP.

General Conference Committee (§?149.3)

Proposed §?149.3 would outline rules governing the GCC. The US SHIP GCC is primarily modeled on the US SHIP pilot program's GCC as described above. As noted above, however, the pilot program's GCC is an industry-governed body making recommendations to industry members, whereas under US SHIP the GCC would be a FACA committee making recommendations to APHIS regarding the administration of the Program. As described above, delegates at the House of Delegates meeting elect the GCC members. The GCC members will serve as an advisory committee to the US SHIP program to provide these recommended changes to APHIS.

Proposed §?149.3(a) would provide that the GCC Chairperson and the Vice Chairperson shall be elected by the members of the GCC by simple majority. This provision is modeled from the US SHIP pilot program's GCC. The paragraph also states that a representative of APHIS will serve as the Executive Secretary, who provides staff support for the GCC. The pilot program's GCC does not have this provision, but it must be added because of APHIS' administration of US SHIP. The paragraph also would provide that the GCC shall consist of nine members. It would also provide that, when members are affiliated with a swine production premises or slaughter plant, that premises or plant must maintain US SHIP certification status in good standing. GCC members must also not have any known violations of other APHIS regulations within the past three years. This provision is modeled the US SHIP pilot program's GCC.

[top] The paragraph would state that the nine members will consist of one member to be elected from each of six designated regions, and three members at large, by delegates at the House of Delegates meeting. A non-voting State Animal Health Official, as recommended by the National Assembly of State Animal Health Officials, will also be appointed to the GCC. This provision is primarily modeled after NPIP, which also uses a mix of regional and at large representatives. As a result of a 2024 recommendation within the US SHIP pilot program, however, the proposed rule is different from NPIP in that it adds a non-voting State Animal Health Official. The designated regions within US SHIP would differ from those in NPIP; rather, they track the regions

during the pilot program, which are based on the number of swine operations in each region. These designations help ensure relative parity among regions in terms of operations covered. As noted above, there would be six designated regions proposed in US SHIP, consisting of the following States and territories:

• North Atlantic: Maine, New Hampshire, Vermont, Massachusetts, Rhode Island, Connecticut, New York, New Jersey, Pennsylvania, Delaware, Maryland, West Virginia, Ohio, Michigan, and Kentucky.

• East Central: Wisconsin, Indiana, Illinois, and Missouri.

• North Central: North Dakota, South Dakota, and Minnesota.

• Central: Iowa.

• South Atlantic: Virginia, North Carolina, Tennessee, Arkansas, Louisiana, Mississippi, Alabama, Georgia, South Carolina, Florida, and Puerto Rico.

• Western: Texas, Oklahoma, Kansas, Nebraska, Colorado, Wyoming, Montana, Idaho, New Mexico, Arizona, Utah, Nevada, Washington, Oregon, California, Alaska, and Hawaii.

Proposed §?149.3(a)(7) provides that delegates will elect one member-at-large from representatives of the slaughtering facilities and one member-at-large from non-commercial facilities designations. This provision is modeled on the rules governing the US SHIP pilot program's GCC, which also includes representatives affiliated with these two classifications.

Proposed §?149.3(a)(8) would state that one member at large will be elected without geographic or classification affiliation. Additionally, it would state that no more than two members of any standing GCC may be employed by, or associated with, the same business entity. This latter provision is meant to preclude one business entity from having disproportionate influence over the decisions of the GCC.

Proposed §?149.3(b) would provide that the regional committee members will be elected by the official delegates of their respective regions, and the members-at-large will be elected by all voting delegates. These provisions are modeled on the rules governing the GCC within NPIP, and also governed the US SHIP pilot program's GCC. Delegate selection would be discussed in proposed §?149.5.

Proposed §?149.3(c) would state that three GCC members shall be elected at each House of Delegates meeting. All members shall serve for a period of 3 years, subject to the continuation of the Committee by the Secretary of Agriculture. In the event that there is a mid-term vacancy of a GCC position, the GCC shall make an interim appointment by simple majority vote of its members, and the appointee shall serve until the next House of Delegates at which time an election will be held. That election will be to fill the remaining term of the vacated position. These provisions also governed the US SHIP pilot program's GCC.

Proposed §?149.3(d) would outline the duties of the GCC. Proposed §?149.3(d)(1) would provide that the GCC should represent the interests of the entire United States swine industry regarding the operation of US SHIP. This provision also governed the US SHIP pilot program's GCC.

Proposed §?149.3(d)(2) would state that the GCC should advise the Department on the relative importance of maintaining adequate departmental funding for US SHIP to enable the APHIS Senior Coordinator and other Department staff to fully administer the provisions of the Plan. This provision is not present in the pilot program, because it is, again, administered by the industry itself. However, as noted above, the codified US SHIP regulations would be an APHIS-administered program in which an industry-led Federal advisory committee would advance policy recommendations to the Department.

Proposed §?149.3(d)(3) would state that the GCC shall advise and make yearly recommendations to the Department with respect to the Plan budget well in advance of the start of the budgetary process. This provision is not present in the pilot program, but, for similar reasons to the foregoing provision, is necessary as US SHIP transitions to an APHIS-administered program.

Proposed §?149.3(d)(4) would state that the GCC shall assist the Department in planning, organizing, and conducting the Swine Health Improvement Plan House of Delegates Meeting. The US SHIP pilot administrative team plans and organizes the House of Delegates meeting under the pilot program; however, as US SHIP transitions to an APHIS-administered program working in consort with a FACA committee, this role would likewise shift to one of joint assistance in planning and organizing the conference.

Proposed §?149.3(d)(5) would state that the GCC shall advise and make recommendations to the Department with respect to the Swine Health Improvement Plan Technical Committees' leadership selection and composition. This provision is modeled on NPIP, which also makes use of a Technical Committee.

Proposed §?149.3(d)(6) would state that the GCC shall review each proposal submitted to be considered by the House of Delegates. It also would state that the GCC shall meet jointly with the Swine Health Improvement Plan Technical Committees to consider the technical aspects of each proposal. This provision also governed the interaction between the GCC and House of Delegates within the US SHIP pilot program.

Proposed §?149.3(d)(7) would outline the areas in which the GCC shall represent the entire United States swine industry in the interim between House of Delegates meetings:

• Advising the Department regarding administrative procedures and interpretations of the Plan provisions as contained in parts 148 and 149. This provision is modeled on a similar provision within NPIP. The pilot program's GCC does not have this provision, but it must be added as US SHIP transitions to an APHIS-administered program working in consort with a FACA committee.

• Assisting the Department in evaluating comments received from interested persons concerning proposed amendments to the Plan. Again, this provision, which is modeled on a similar provision within NPIP, did not govern the pilot program's GCC but must be added as US SHIP transitions to an APHIS-administered program working in consort with a FACA committee.

• Recommending to the Secretary of Agriculture any changes in the provisions of the Plan in situations where postponement until the next House of Delegates would seriously impair operation of the program. Such recommendations would remain in effect only until confirmed or rejected by the next House of Delegates, or until they are rescinded by the committee. This provision, which is also modeled on a similar provision within NPIP, did not govern the pilot program's GCC but must be added as US SHIP transitions to an APHIS-administered program working in consort with a FACA committee.

• The Committee may convene an emergency meeting of the House of Delegates as the need arises. This provision governs the GCC during the pilot program and would remain in effect.

[top] Proposed §?149.3(d)(8) provides that the GCC shall serve as an official advisory committee for the study of problems relating to swine health and, as the need arises, shall make specific recommendations to the Secretary of Agriculture concerning ways in which

the Department may assist the industry in addressing these issues. The pilot program's GCC does not have this provision, which is modeled on a provision within NPIP, but it must be added as US SHIP transitions to an APHIS-administered program working in consort with a FACA committee.

Proposed §?149.3(d)(9) states that the GCC shall serve as a direct liaison between the US SHIP and the United States Animal Health Association (USAHA). This provision is modeled on a similar provision within NPIP and would establish the GCC's role as an intermediary between APHIS and USAHA regarding matters pertaining to US SHIP as US SHIP transitions to an APHIS-administered program working in consort with a FACA committee.

Proposed §?149.3(d)(10) would state that the GCC shall advise and make recommendations to the Department regarding US SHIP involvement or representation at swine industry functions and activities as deemed necessary or advisable for the purposes of the Plan. This provision is also modeled on a similar provision with NPIP. The pilot program's GCC does not have this provision, but it is necessary as US SHIP transitions to an APHIS-administered program working in consort with a FACA committee.

Submitting, Compiling, and Distributing Proposed Changes (§?149.4)

Proposed §?149.4(a) would provide that changes to the regulations may be proposed by any participant, OSA, the Department, or any other interested person or industry organization. This provision, which is modeled on a similar provision within NPIP, was not part of the pilot program, but it is necessary as US SHIP transitions to an APHIS-administered program working in consort with a FACA committee.

Proposed §?149.4(b) would provide that proposed changes must be submitted in writing and reach APHIS no later than 100 days prior to the opening date of the House of Delegates Meeting, and that participants in the Plan must submit any proposed changes through their OSA. This provision is also modeled on a similar provision within NPIP and was not part of the pilot program but is necessary as US SHIP transitions to an APHIS-administered program working in consort with a FACA committee.

Proposed §?149.4(c) would provide that the name of the proponent must be indicated on each proposed change when submitted and that each proposal should be accompanied by a short supporting statement. This provision is modeled on a similar provision within NPIP and was part of the pilot program.

Proposed §?149.4(d) would require APHIS to notify all persons on the US SHIP mailing lists concerning the dates and general procedure of the House of Delegates Meeting. This provision is also modeled on a similar provision within NPIP and was not part of the pilot program but is necessary as US SHIP transitions to an APHIS-administered program working in consort with a FACA committee.

Proposed §?149.4(e) would require APHIS to compile the proposed changes, together with the names of the proponents and supporting statements and distribute the proposed changes. If two or more similar changes are submitted, APHIS would try to unify them into one proposal acceptable to all proponents. Copies would be distributed to officials of the OSAs working with US SHIP. Additional copies would be made available in response to individual requests. This provision is modeled on a similar provision within NPIP, and the basic procedure for compiling proposed changes was substantially similar within the pilot program. However, the pilot program does not give APHIS the role of compiler.

Official Delegates (§?149.5)

Proposed §?149.5 would outline the rules governing official delegates to the US SHIP House of Delegates. The section provides that each cooperating State shall be entitled to one or more official delegates, and that the official delegates shall be elected by a representative group of participating industry members and be certified by the OSA. It further provides that it is recommended, but not required, that the official delegates be Plan participants. The section also states that official delegate allocations for cooperating States will be calculated using methods outlined in the Program Standards. This section states that each official delegate shall try to obtain, prior to the House of Delegates conference, the recommendations of industry members of their State regarding each proposed change. All of these provisions are modeled on the US SHIP pilot program's House of Delegates. Changes to the rules governing the House of Delegates will be made in accordance with proposed §?149.9. As with other sections of the proposed regulations, these provisions are modeled after similar provisions in NPIP, with some changes to reflect the specific needs of US SHIP.

Committee Consideration of Proposed Changes (§?149.6)

Proposed §?149.6 would outline rules for the formation of committees and consideration of proposed changes to the regulations or US SHIP Program Standards.

Proposed §?149.6(a) provides that a Biosecurity committee, a Traceability Committee, and a Sampling and Testing Committee shall be formed to consider changes in their respective fields. These committees and their respective fields are drawn from the US SHIP pilot program.

Proposed §?149.6(b) provides that the committees must discuss related proposals with other committees.

Proposed §?149.6(c) would provide that the committees shall make recommendations to the House of Delegates concerning each proposal. The individual committee reports shall be submitted to the chairperson of the House of Delegates, who will combine them into a single report showing, in numerical order, the committee recommendations on each proposal. As stated in this text, if the committee makes a recommendation, the House of Delegates report shall show any proposed change in wording. These provisions are drawn from the US SHIP pilot program.

The proposed paragraph would further state that, once completed, the combined committee report will be distributed electronically to the OSAs prior to the delegates voting on the final day of the House of Delegates conference. This provision involving the OSAs is not present in the pilot program, but it is necessary as US SHIP transitions to an APHIS-administered program working in consort with State cooperators and a FACA committee.

Proposed §?149.6(d) would provide that Technical Committee meetings shall be open to any interested person, and that advocates for or against any proposal may appear before the appropriate committee and present their views.

House of Delegates Consideration of Proposed Changes (§?149.7)

Proposed §?149.7(a) would state that the chairperson of the House of Delegates shall be a representative of the Department. This provision is not present in the pilot program, but it is necessary as US SHIP transitions to an APHIS-administered program.

[top] Proposed §?149.7(b) would provide that, at the time designated for voting on proposed changes by official delegates, the chairperson of the GCC and all committee chairpersons shall sit at the

speaker's table and assist the chairperson of the House of Delegates at the time designated for voting on proposed changes by the official delegates. This provision is drawn from the procedures of the GCC in the US SHIP pilot program.

Proposed §?149.7(c) would state that the chairperson shall set the rules of order for the GCC. This provision is drawn from the procedures of the GCC in the US SHIP pilot program.

Proposed §?149.7(d) would state that proposals that have not been submitted in accordance with §?149.5 will be considered by the House of Delegates only with the unanimous consent of the GCC. Any such proposals must be referred to the appropriate committee for consideration before being presented for action by the House of Delegates. These provisions are drawn from the US SHIP pilot program.

Proposed §?149.7(e) would state that voting will be by States, and each official delegate, as determined by §?149.5, will be allowed one vote on each proposal. This provision is drawn from the US SHIP pilot program.

Proposed §?149.7(f) would state that a roll call of States for a recorded vote will be used when requested by a delegate or at the discretion of the chairman. This provision is drawn from the US SHIP pilot program.

Proposed §?149.7(g) would state that all motions on proposed changes shall be for adoption. This provision is drawn from the US SHIP pilot program.

Proposed §?149.7(h) would state that proposed changes shall be adopted by a two-thirds majority vote of the official delegates present and voting. This provision is drawn from the US SHIP pilot program.

Proposed §?149.7(i) would state that the House of Delegates conference shall be open to any interested person. This provision is drawn from the US SHIP pilot program.

Approval of House of Delegates Recommendations by the Department (§?149.8)

Proposed §?149.8 would state that proposals adopted by the official delegates will be recommended to the Department for incorporation into US SHIP in parts 148 and 149. The paragraph also would reserve the right for the Department, as the sponsor of US SHIP, to approve or disapprove the recommendations of the House of Delegates.

Changes to the US SHIP Program Standards (§?149.9)

Proposed §?149.9 would provide the notice-based processes by which certain changes to the US SHIP Program Standards would be made.

The introductory text of the section would provide that the US SHIP Program Standards document references details on tests and sample types that have been approved by the Administrator for diseases covered by the regulations in proposed part 148, approved procedures for maintaining biosecurity at a participating swine operation, and calculations for official delegate allocations. It further would provide that changes to any of the foregoing will be made in the manner set forth in paragraphs (a) and (b) of the section.

Proposed §?149.9(a) would contain the normal process for making such changes. Under this process, we would publish a notice in the Federal Register providing the proposed changes to the US SHIP Program Standards document and the basis for the changes. The notice would request public comment. If no comments are received on the notice, or if the comments received do not call into question the basis for the changes, we would publish a subsequent notice in the Federal Register announcing that the changes have been made to the US SHIP Program Standards document and making available the revised US SHIP Program Standards document. If comments identify concerns with the proposed revisions or call into question the basis for the changes, APHIS would consider and address those comments as appropriate prior to making any changes.

Proposed §?149.9(b) would provide the process for making immediate changes to the US SHIP Program Standards document. If the Administrator determines that that procedures for maintaining biosecurity and animal traceability at participating swine operations that are described in the US SHIP Program Standards document are not adequate, or that testing procedures must be revised in order to ensure that they provide reliable assurances regarding test results, we would make the relevant change to the US SHIP Program Standards document. As soon as is feasible, we would publish a notice in the Federal Register announcing the change, as well as the basis for the change. The notice would request public comment. Under this process, we may make further revisions the Program Standards document based on the comments received. If comments identify concerns with the proposed revisions or call into question the basis for the changes, APHIS would consider and address those comments as appropriate prior to making any changes.

Executive Orders 12866 and Regulatory Flexibility Act

This proposed rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. Copies of the full analysis are available by contacting the person listed under FOR FURTHER INFORMATION CONTACT or on the Regulations.gov website (see ADDRESSES above for instructions for accessing Regulations.gov ).

This proposed rulemaking would result in the creation of regulations governing the US Swine Health Improvement Plan (US SHIP), 9 CFR parts 148 and 149. 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. The proposal would codify US SHIP as a Federal regulatory program and allow participants to obtain certifications of disease-monitored status for African swine fever and classical swine fever. Establishment of US SHIP would allow participants to market their products with the relevant certification status, which could limit disruptions to international and interstate commerce during outbreaks.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service (APHIS) has determined that this action will not have a significant economic impact on a substantial number of small entities.

Executive Order 12372

This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 2 CFR chapter IV.)

Executive Order 12988

[top] This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted: (1) All State and local laws and regulations that are in conflict with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings

will not be required before parties may file suit in court challenging this rule.

Paperwork Reduction Act

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), the information collection or recordkeeping requirements included in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB).

Written comments and recommendations for the proposed information collection should be sent within 60 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting "Currently under Review-Open for Public Comments" or by using the search function. Please send a copy of your comments to: (1) Docket No. APHIS-2022-0061, Regulatory Analysis and Development, PPD, APHIS, Station 2C-10-16, 4700 River Road, Unit 25, Riverdale, MD 20737-1238, and (2) Clearance Officer, OCIO, USDA, Room 404-W, 14th Street and Independence Avenue SW, Washington, DC 20250. A comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication of this proposed rule. APHIS will respond to any information collection-related comments in the final rule. All comments will also become a matter of public record. For assistance with the Paperwork Reduction Act or information collection reporting process, please write to aphis.pra@usda.gov or telephone (301) 851-2533.

APHIS is proposing the creation of new regulations, 9 CFR parts 148 and 149, governing the United States Swine Health Improvement Plan ("US SHIP"), a voluntary livestock improvement program aimed at bettering biosecurity, traceability, and disease surveillance for swine health. The swine industry requested the establishment of US SHIP, which builds on an existing pilot program initiated by the swine industry. The proposal would codify US SHIP as a Federal regulatory program and allow participating sites to obtain certifications of disease-free status for African swine fever and classical swine fever. Establishment of US SHIP would allow producers to market their products with the relevant disease-free status which could limit disruptions to international and interstate commerce during outbreaks.

New information collection activities resulting from this proposed rule affect State government agency and commercial respondents. These activities include memoranda of understanding and cooperative agreement financial and performance reporting; site enrollment and compliance statements; applications for certification; interstate certificates of veterinary inspection; periodic State data reports, animal movement reports, herd and site inspections; biosecurity plans; cancellation/debarment and reconsideration of cancellations; solicitation of participant input on program implementation and solicitation of current industry practices to inform program standards; and recordkeeping. Further information on the activities can be found in this proposed rulemaking and in the information collection request submitted to OMB.

We are soliciting comments from the public (as well as affected agencies) concerning our proposed reporting and recordkeeping requirements. These comments will help us:

(1) Evaluate whether the proposed information collection is necessary for the proper performance of our agency's functions, including whether the information will have practical utility;

(2) Evaluate the accuracy of our estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology; e.g., permitting electronic submission of responses).

Estimate of burden: The public burden for this collection of information is estimated to average 0.275 hours [or minutes] per response.

Respondents: Herd owners, breeders, slaughter plant workers, laboratory technicians, State animal health officials, and individuals.

Estimated annual number of respondents: 12,051.

Estimated annual number of responses per respondent: 18.

Estimated annual number of responses: 213,112.

Estimated total annual burden on respondents: 60,463 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

E-Government Act Compliance

The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. Official State Agencies will maintain in the US SHIP Site Status Verification Database limited collected information. Detailed participant and premises level-specific identifiers remain with the respective US SHIP OSA and are not reported to, or contained in, the US SHIP Site Status Verification Database. At this time, other activities are documented on paper. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Mr. Joseph Moxey, APHIS' Paperwork Reduction Act Coordinator, at (301) 851-2533.

List of Subjects in 9 CFR Parts 148 and 149

Swine, producers, slaughtering facilities, certification, African swine fever, Classical swine fever, Official State Agency.

Accordingly, under the authority of 7 U.S.C. 8301 et seq., we propose to amend 9 CFR chapter I by adding parts 148 and 149 to subchapter G to read as follows:

PART 148-UNITED STATES SWINE HEALTH IMPROVEMENT PLAN

Subpart A-General Provisions

Sec. 148.1 Definitions.148.2 Administration.148.3 Participation.148.4 General provisions for all participants.148.5 Terminology and classification; general.148.6 Terminology and classification; herds and products.148.7 Supervision.148.8 Maintenance of Certification.148.9 Debarment from participation.148.10 Testing.148.11 Authorized laboratories.

Subpart B-Special Provisions For Slaughtering Facilities

Sec. 148.21 Definitions.148.22 Participation.148.23 Terminology and classification; slaughtering facilities.

Authority:

7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

§?148.1 Definitions.

[top] For the purpose of this subpart, unless the context otherwise requires, the following terms shall have the meanings assigned to them in this section. The

singular form shall also impart the plural.

Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.

African swine fever (ASF). A highly contagious viral hemorrhagic disease cause by a large, enveloped, double-stranded DNA virus of the family Asfarviridae and genus Asfivirus that affects animals in the family Suidae, including domestic pigs, feral swine, and Eurasian wild boar.

Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the U.S. Department of Agriculture.

Authorized agent. Any person designated under §?148.7 to collect official samples for submission to an authorized laboratory in accordance with §?148.10.

Authorized laboratory. A laboratory that meets the requirements of §?148.11 and is thus qualified to perform assays in accordance with this part.

Boar. A sexually intact male swine.

Boar stud. A swine production site with mature boars that distributes semen to other swine production sites.

Classical swine fever (CSF). A highly contagious viral septicemia, caused by a small, enveloped RNA virus of the family Flaviviridae and genus Pestivirus, that affects animals in the family Suidae, including domestic pigs, feral swine, and Eurasian wild boar.

Department. The U.S. Department of Agriculture (USDA).

Farrow to feeder/finisher facility. A swine production site with breeding females (gilts and/or sows) and grow feeder swine for purposes other than breeding stock replacement for this particular farm site, and that houses =1,000 breeder or feeder swine.

Feral swine. Free-roaming swine.

Gilt. A young female swine that has not produced a litter.

Growing pig facility. A swine production site with =1,000 feeder swine (nursery, grower, or finisher).

Live animal marketing operation. A dealer with a livestock yard/buying facility that markets swine for resale of such swine to slaughter facilities.

National Animal Health Laboratory Network (NAHLN). The NAHLN is a nationally coordinated network and partnership of primarily Federal, State, and university-associated animal health laboratories that provide animal health diagnostic testing, methods research and development, and expertise for education and extension to detect biological threats to the nation's animal agriculture, thus protecting animal health, public health, and the nation's food supply.

Non-commercial facility. A swine production site with <100 breeding swine (gilts, boars, and/or sows) or feeder swine. Backyard, exhibition, or niche swine production sites are considered non-commercial facilities if they maintain fewer than 100 breeding swine or feeder swine.

Official State Agency. The State veterinary authority recognized by the Department to cooperate in the administration of the Plan.

Person. A natural person, firm, or corporation.

Plan. The provisions of the US Swine Health Improvement Plan (US SHIP) contained in this part.

Pork product. A product or byproduct produced or processed in whole or in part from swine.

Senior Coordinator. An employee of APHIS whose duties may include, but will not necessarily be limited to:

(1) Serving as Executive Secretary of the General Conference Committee;

(2) Serving as chairperson of the House of Delegates conference;

(3) Coordinating the State administration of the US SHIP through periodic reviews of the administrative procedures of the Official State Agencies, according to the applicable provisions of the Plan and the Memorandum of Understanding; and

(4) Coordinating future rulemakings to incorporate the proposed changes of the provisions adopted at the House of Delegates meeting into the regulations in this part and part 149 of this subchapter.

Small holding facility. A swine production site with =100 and <1,000 breeding swine (gilts, boars, and/or sows) or feeder swine.

Sow. An adult female swine that has produced one or more litters.

State. Any State, the District of Columbia, or Puerto Rico.

Swine. A porcine animal raised to be a feeder pig, raised for seedstock, raised for exhibition, or raised for slaughter.

US SHIP Program Standards. A document that contains biosecurity, traceability, and sampling and testing procedures approved by the Administrator for use under this part and part 149 of this subchapter. This document may be obtained from the US SHIP website at [ADDRESS TO BE ADDED IN FINAL RULE] or by writing to APHIS at US Swine Health Improvement Plan (US SHIP), APHIS, USDA, 920 Main Campus Drive, Suite 200, Raleigh, NC 27606.

US SHIP Technical Committee. A committee made up of technical experts on swine health, including topics such as biosecurity, traceability, and sampling and testing. The committee consists of representatives from the swine and pork products industries, universities, and State and Federal governments that are appointed by the Senior Coordinator and reviewed by the General Conference Committee. The committee will consider proposed changes to the Provisions and Program Standards of the Plan and provide recommendations to the House of Delegates as to whether they are scientifically or technically sound.

§?148.2 Administration.

(a) The Department cooperates with Official State Agencies in the administration of the Plan through a Memorandum of Understanding. In the Memorandum of Understanding, the Official State Agency must designate a contact representative to serve as a liaison between APHIS and the Official State Agency.

(b) The administrative procedures, decisions, and records of the Official State Agency relevant to the implementation of US SHIP are subject to review by APHIS. The Official State Agency shall carry out the administration of the Plan within the State according to the applicable provisions of the Plan and the Memorandum of Understanding.

(c) The Official State Agency of any State may adopt regulations applicable to the administration of the Plan in such State that further define the provisions of the Plan or establish higher standards compatible with the Plan.

(d) Laboratories authorized in accordance with §?148.11 will conduct diagnostic testing when determining the status of a participating herd with respect to official Plan classifications.

§?148.3 Participation.

(a) The US SHIP is a cooperative Federal-State-Industry program for preventing and monitoring specific swine diseases. US SHIP will apply new or existing diagnostic technology. US SHIP establishes and implements certification programs that identify 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 that meet biosecurity, traceability, and surveillance standards for specific diseases articulated in this part in States with Official State Agencies that operate under a Memorandum of Understanding with the Department pursuant to §?148.2.

[top] (b) Any person producing or dealing in swine or pork products may

participate in US SHIP when they have demonstrated, to the satisfaction of the Official State Agency, that their facilities, personnel, and practices are adequate for carrying out the applicable provisions of the Plan and has signed an agreement with the Official State Agency to comply with the general and the applicable specific provisions of the Plan and any regulations of the Official State Agency under §?148.2.

(d) Any person seeking to enroll in any participating State may participate with any of their eligible swine operations or slaughter facilities within each participating State. The prospective participant shall enroll by providing the following information to the Official State Agency:

(1) Name, address, and contact information of the swine owner or owner of the slaughtering facility (US SHIP participant);

(2) Address (including latitude and longitude, if a 911 address is not available for the site) of animal location, and name and contact information of the premises (site) owner;

(3) Premises identification number (PIN) of physical participating site location (animal location) and common name of site;

(4) Premises type, such as 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;

(5) Expected site capacity (number of swine), unless the site is a slaughtering facility;

(6) Name and contact information of the individual submitting an acknowledgment that they understand and intend to comply with the regulations and relevant US SHIP Program Standards; and

(7) Acknowledgement by this individual that they understand and intend to comply with the regulations and relevant US SHIP Program Standards and the date of their acknowledgement.

(e) No person shall be compelled by the Official State Agency to qualify swine or pork products for any of the other classifications described in §?148.10 as a condition of qualification for the U.S. African Swine Fever-Classical Swine Fever Monitored certification. Participation in the U.S. African Swine Fever-Classical Swine Fever Monitored certification, however, is a condition of participation in such other classifications.

(f) Participation in the Plan shall entitle the participant to use the Plan emblem reproduced at [ADDRESS TO BE ADDED IN FINAL RULE]. If APHIS proposes to revise the Plan emblem, APHIS will publish a notice in the Federal Register making available the revised emblem, as well as the basis for the revisions, and requesting public comment. If no comments are received on the notice, or if the comments received do not call into question the basis for the revisions, APHIS will publish a subsequent notice in the Federal Register responding to the comments received and announcing the revised emblem. If comments identify concerns regarding the basis for the proposed revisions, however, APHIS will take no action to revise the emblem until addressing those concerns as appropriate.

§?148.4 General provisions for all participants.

(a) Participants must retain records necessary for demonstrating compliance with certification requirements.

(b) A participant's animals, animal products, and records as needed to confirm certification requirements of swine or pork products, and material used to advertise products, are subject to inspection by the Official State Agency or APHIS at any time in accordance with §?148.8(b) and any additional requirements by the Official State Agency.

(c) Advertising must be in accordance with the Plan, and applicable rules and regulations of APHIS, the Official State Agency, and the Federal Trade Commission. A participant advertising swine or pork products as being of any official classification may include in their advertising reference to associated or franchised facilities only when such facilities produce swine or pork products carrying the same official classification.

(d) APHIS and the Official State Agency will use PINs to verify participation in the Plan. Existing PINs will be recognized for this purpose, and the Official State Agency will assign a new PIN for participants who do not have an existing PIN.

§?148.5 Terminology and classification; general.

(a) The official classifications provided in §?148.6 and the various designs illustrative of the official classifications reproduced at [ADDRESS TO BE ADDED IN FINAL RULE] may be used only by participants and to describe swine or pork products that have met all the specific requirements of such classifications.

(b) Swine and pork products produced under the Plan shall lose their identity under Plan terminology when they are purchased for resale by, or consigned to, nonparticipants.

§?148.6 Terminology and classification; herds and products.

(a) Terms and classifications for participating swine operations. Participating swine operations and products produced from them which have met the respective requirements specified in this section for a particular term or classification may be designated by the corresponding emblem illustrated at [ADDRESS TO BE ADDED IN FINAL RULE]. If APHIS proposes to revise an emblem, APHIS will publish a notice in the Federal Register making available the revised emblem, as well as the basis for the revision, and requesting public comment. If no comments are received on the notice, or if the comments received do not call into question the basis for the revisions, APHIS will publish a subsequent notice in the Federal Register responding to the comments received and announcing the revised emblem. If comments identify concerns regarding the basis for the proposed revisions, however, APHIS will take no action to revise the emblem until addressing those concerns as appropriate.

(b) ASF-CSF Monitored. This program is intended to be the basis from which swine operations enact measures for the prevention and monitoring of ASF-CSF. The program is intended to assist with the detection of ASF-CSF in swine through monitoring for clinical signs or suspicious test results for ASF-CSF and participation in the active ASF-CSF surveillance program. A swine operation and all swine or pork products produced by that operation will qualify as "ASF-CSF Monitored" when the Official State Agency determines that a prospective participant has met the following requirements:

(1) The swine operation only introduces herd additions that have either been exclusively sourced from certified ASF-CSF Monitored sites or sites that have participated in testing and clinical observation of their herds sufficient to demonstrate freedom from ASF and CSF.

[top] (2) The swine operation collects samples and submits them for testing for any disease incident or death loss that is suggestive of ASF or CSF. Testing must be conducted through the USDA Swine Hemorrhagic Fevers Surveillance Plan or a foreign animal disease investigation at a laboratory authorized in accordance with §?148.11 and using

tests approved by the Administrator to detect the presence of ASF and CSF. Requirements for participant sampling and testing can be found in the Program Standards.

(3) The swine operation demonstrates and maintains competency in tracking all swine movements onto and off of certified sites, as described in the US SHIP Program Standards.

(4) The swine operation maintains biosecurity in a manner approved by APHIS and verified by the Official State Agency. Approved procedures for maintaining biosecurity are listed in the US SHIP Program Standards. Changes to the US SHIP Program Standards will be made in accordance with §?149.9 of this subchapter.

§?148.7 Supervision.

(a) The Official State Agency may designate qualified persons as authorized agents collect samples for diagnostic testing as required by §?148.10.

(b) The Official State Agency shall employ or authorize qualified persons as State inspectors to verify compliance with the requirements of the Plan.

(c) Authorities of qualified persons to collect samples or verify program compliance that are issued under the provisions of this section shall be subject to cancellation by APHIS or by the Official State Agency on the grounds of incompetence or failure to comply with the provisions of the Plan or failure to comply with regulations of APHIS or the Official State Agency. Such actions shall not be taken until a thorough investigation has been made by APHIS or the Official State Agency and the authorized person has been given notice of the proposed action and the basis therefore and has an opportunity to present their views.

§?148.8 Maintenance of Certification.

(a) The Official State Agency will verify whether each certified participant continues to meet the requirements to maintain certification at least one time annually, or more if determined appropriate for purposes of determining Plan compliance.

(b) All participant records supporting continued program participation must be able to be made available to a State inspector and examined at least annually. The Official State Agency must maintain enrollment records for 5 years after the date of enrollment and inspection records for 3 years after the date of inspection. The Official State Agency will arrange on-site inspections of herds and premises by its representatives or designee if the State inspector has reasonable basis to believe that a breach of biosecurity, specimen testing, or other provision may have occurred for Plan programs for which the herds have qualified. The Official State Agency must provide a summary of the compliance concerns it investigated and its recommended resolutions or outcomes to APHIS for review and possible further action.

(c) APHIS may conduct on-site inspections of herds and premises if it has reasonable basis to believe that a breach of biosecurity, specimen testing, or other provisions may have occurred.

§?148.9 Debarment from participation.

(a) Upon completion of an investigation by the Official State Agency, its representative, or APHIS, APHIS will notify the participant in writing of their compliance or noncompliance with the Plan provisions or regulations of the Official State Agency. In the event of a finding of noncompliance, the notification will articulate that APHIS may debar the participant from further participation in the Plan if the noncompliance concerns are not addressed, and will afford the participant at least 30 days to demonstrate or achieve compliance. If compliance is not demonstrated or achieved within the specified time, APHIS may debar the participant from further participation in the Plan, including any opportunities to market product or animals as having originated from a Plan participant, until the participant can demonstrate compliance with the plan. APHIS shall provide the debarred participant with written notice of the bases for the debarment. Such decision shall be final unless the debarred participant, within 30 days after the issuance of the written notice of debarment, requests the Administrator to review the eligibility of the debarred participant for participation in the Plan. The request for review must state all facts and reasons upon which the participant relies to consider the debarment order to be error. As promptly as circumstances allow, the Administrator will respond in writing to uphold or reverse the debarment.

(b) [Reserved]

§?148.10 Testing.

Samples for official tests shall be collected by a Federal inspector, State inspector, or its authorized agent. Samples must be tested by a laboratory authorized in accordance with §?148.11. Procedures for testing shall be described in the Program Standards. Changes to these procedures will be made in accordance with §?149.9 of this subchapter.

§?148.11 Authorized Laboratories.

In order to be authorized to conduct testing as provided for in §?148.10, laboratories must be approved by APHIS in accordance with §?71.22 of this chapter and must be NAHLN laboratories approved as proficient in the assays for diseases specified as part of US SHIP. Authorized laboratories will follow the NAHLN guidance document for reporting diseases specified as part of US SHIP directly to APHIS.

Subpart B-Special Provisions For Slaughtering Facilities

§?148.21 Definitions.

For the purpose of this subpart, unless the context otherwise requires, the following term shall have the meaning assigned to it in this section. The singular form shall also impart the plural.

Slaughtering facility. A slaughter plant processing swine that is federally inspected or under State inspection that the U.S. Department of Agriculture's Food Safety and Inspection Service has recognized as equivalent to Federal inspection.

§?148.22 Participation.

(a) Participating slaughtering facilities shall comply with the provisions in §?148.4 and the special provisions of this subpart.

(b) Except for the information required in §?148.3(d)(5), participating slaughtering facilities shall provide the same information required for other participants as outlined in §?148.3(d). For purposes of complying with §?148.3(d)(5), slaughtering facilities must provide expected slaughter capacity (number of swine slaughtered daily/weekly).

§?148.23 Terminology and classification; slaughtering facilities.

[top] (a) Terms and Designs for Participating Slaughtering Facilities. Participating slaughtering facilities which have met the respective requirements specified in this section may be designated by the terms and their corresponding designs. The terms and corresponding designs will be illustrated at [ADDRESS TO BE ADDED IN FINAL RULE]. If APHIS proposes to revise the Plan terms and corresponding designs, APHIS will publish a notice in the Federal Register making available the revised terms and designs, as well as the basis for the revisions, and requesting public comment. If no comments are received on the notice, or if the comments received do not call into question the basis for the revisions,

APHIS will publish a subsequent notice in the Federal Register responding to the comments received and announcing the revised terms and designs. If comments identify concerns with the proposed revisions, APHIS will consider and address those comments as appropriate.

(b) ASF-CSF Monitored. This program is intended to determine the presence of ASF and CSF in swine through routine monitoring of each participating slaughtering facility. A participating slaughtering facility will qualify for the ASF-CSF Monitored is classification when the Official State Agency determines that it has met both of the following requirements:

(1) Any participant slaughtering facility handling ASF-CSF Monitored slaughter swine must be able to keep those swine and swine pork products separate from other swine and swine pork products from source farms not enrolled certified as ASF/CSF Monitored in the Plan in a manner satisfactory to the Official State Agency.

(2) Participants must report disease events with clinical signs compatible with ASF-CSF, including ante- or post-mortem indicators of possible hemorrhagic disease, for surveillance testing. Compatible clinical signs are listed in the US SHIP Program Standards.

PART 149-PROCEDURE FOR CHANGING THE UNITED STATES SWINE HEALTH IMPROVEMENT PLAN

Sec. 149.1 Definitions.149.2 General.149.3 General Conference Committee.149.4 Submitting, compiling, and distributing proposed changes.149.5 Official Delegates.149.6 Committee consideration of proposed changes.149.7 House of Delegates consideration of proposed changes.149.8 Approval of House of Delegates recommendations by the Department.149.9 Changes to the US SHIP Program Standards.

Authority:

7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

§?149.1 Definitions.

For the purpose of this part, unless the context otherwise requires, the following terms shall have the meanings assigned to them in this section. The singular form shall also impart the plural.

Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.

Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the U.S. Department of Agriculture.

Department. The U.S. Department of Agriculture.

House of Delegates. A decision-making body composed of U.S. swine industry participants and subject matter experts that aim to represent the interests of swine industry stakeholders across each of the participating States. The House of Delegates meets at regular intervals for the purpose of sharing research and outcomes from program-related initiatives, reviewing and voting on proposed program changes, and formally facilitating the program's development.

Official State Agency. The State veterinary authority recognized by the Department to cooperate in the administration of the Plan.

Person. A natural person, firm, or corporation.

Plan. The provisions of the US Swine Health Improvement Plan (US SHIP) contained in this part.

Senior Coordinator. An employee of the Service whose duties may include, but will not necessarily be limited to:

(1) Serving as Executive Secretary of the General Conference Committee;

(2) Serving as chairperson of the House of Delegates Conference;

(4) Coordinating future rulemakings to incorporate the proposed changes of the provisions adopted at the House of Delegates meeting into the regulations in part 148 of this subchapter and this part.

State. Any State, the District of Columbia, or Puerto Rico.

Swine. A porcine animal raised to be a feeder pig, raised for seedstock, raised for exhibition or raised for slaughter.

US SHIP Program Standards. A document that contains biosecurity, traceability, and sampling and testing procedures approved by the Administrator for use under part 148 of this subchapter and this part. This document may be obtained from the US SHIP website at [ADDRESS TO BE ADDED IN FINAL RULE] or by writing to APHIS at US Swine Health Improvement Plan (US SHIP), APHIS, USDA, 920 Main Campus Drive, Suite 200, Raleigh, NC 27606.

§?149.2 General.

Changes in part 148 of this subchapter and this part shall be proposed in accordance with the procedure described in this part, provided that the Department reserves the right to make changes in part 148 of this subchapter and this part without observance of such procedure when such action is deemed necessary in the public interest.

§?149.3 General Conference Committee.

[top] (a) The GCC shall consist of nine elected members. When a member is affiliated with a swine production premises or slaughter plant, that premises or plant must maintain US SHIP certification statuses in good standing. GCC members must also not have any known violations of other APHIS regulations within the past 3 years. The members of the General Conference Committee will elect the Committee Chairperson and the Vice Chairperson by simple majority. An APHIS representative will serve as Executive Secretary and will provide the necessary staff support for the General Conference Committee. A State Animal Health Official without voting responsibilities will also be appointed to the Committee. The appointment shall be based on a recommendation from the National Assembly of State Animal Health Officials. The nine voting General Conference Committee members will consist of one member to be elected, as provided in paragraph (d) of this section, from each of six designated regions, and three members at large. The six designated regions

consist of the States and territories in paragraphs (a)(1) through (6) of this section:

(1) North Atlantic: Maine, New Hampshire, Vermont, Massachusetts, Rhode Island, Connecticut, New York, New Jersey, Pennsylvania, Delaware, Maryland, West Virginia, Ohio, Michigan, and Kentucky.

(2) East Central: Wisconsin, Indiana, Illinois, Missouri.

(3) North Central: North Dakota, South Dakota, and Minnesota.

(4) Central: Iowa.

(5) South Atlantic: Virginia, North Carolina, Tennessee, Arkansas, Louisiana, Mississippi, Alabama, Georgia, South Carolina, Florida, and Puerto Rico.

(6) Western: Texas, Oklahoma, Kansas, Nebraska, Colorado, Wyoming, Montana, Idaho, New Mexico, Arizona, Utah, Nevada, Washington, Oregon, California, Alaska, and Hawaii.

(7) In addition to the above six designated regions, one member-at-large will be elected for each of the following classifications of the Plan:

(i) Slaughtering facilities; and

(ii) Non-commercial facilities.

(8) One member at-large will be elected without geographic or classification affiliation. No more than two members of any standing General Conference Committee may be employed by, or associated with, the same business entity.

(b) The regional committee members will be elected by the official delegates of their respective regions, and the members-at-large will be elected by all voting delegates. Delegate selection, as discussed in §?149.5.

(c) Three members shall be elected at each House of Delegates. All members shall serve for a period of 3 years, subject to the continuation of the Committee by the Secretary of Agriculture. In the event that there is a mid-term vacancy of a General Conference Committee position, the General Conference Committee shall make an interim appointment by simple majority vote of its members, and the appointee shall serve until the next House of Delegates, at which time an election will be held. That election will be to fill the remaining term of the vacated position.

(d) The duties and functions of the General Conference Committee shall be as follows: (1) Represent the interests of the entire United States swine industry with regard to the operation of US SHIP.

(2) Advise and make recommendations to the Department on the relative importance of maintaining adequate departmental funding for the Swine Health Improvement Plan to enable the Senior Coordinator and other Department staff to fully administer the provisions of the Plan.

(3) Advise and make yearly recommendations to the Department with respect to the Swine Health Improvement Plan budget well in advance of the start of the budgetary process.

(4) Assist the Department in planning, organizing, and conducting the Swine Health Improvement Plan House of Delegates Meeting.

(5) Advise and make recommendations to the Department with respect to the Swine Health Improvement Plan Technical Committee leadership selection and composition.

(6) Review each proposal submitted to be considered by the House of Delegates and meet jointly with the Swine Health Improvement Plan Technical Committees to consider the technical aspects and accuracy of each proposal.

(7) During the interim between House of Delegates meetings, represent the entire United States swine industry through the following activities:

(i) Advise the Department with respect to administrative procedures and interpretations of the Plan provisions as contained in part 148 of this subchapter and this part.

(ii) Assist the Department in evaluating comments received from interested persons concerning proposed amendments to the Plan provisions.

(iii) Recommend to the Secretary of Agriculture any changes in the provisions of the Plan as may be necessitated by unforeseen conditions when postponement until the next House of Delegates would seriously impair the operation of the program. Such recommendations shall remain in effect only until confirmed or rejected by the next House of Delegates, or until rescinded by the committee.

(iv) Convene an emergency meeting of the House of Delegates as the need arises.

(8) Serve as an official advisory committee for the study of problems relating to swine health and as the need arises, make specific recommendations to the Secretary of Agriculture concerning ways in which the Department may assist the industry in solving these problems.

(9) Serve as a direct liaison between the US SHIP and the United States Animal Health Association.

(10) Advise and make recommendations to the Department regarding US SHIP involvement or representation at swine industry functions and activities as deemed necessary or advisable for the purposes of the US SHIP.

§?149.4 Submitting, compiling, and distributing proposed changes.

(a) Changes in part 148 of this subchapter and this part may be proposed by any participant, Official State Agency, the Department, or other interested person or industry organization.

(b) Proposed changes must be submitted in writing so as to reach APHIS not later than 100 days prior to the opening date of the House of Delegates Meeting, and participants in the Plan must submit their proposed changes through their Official State Agency.

(c) The name of the proponent must be indicated on each proposed change when submitted. Each proposal should be accompanied by a brief supporting statement.

(d) APHIS will notify all persons on the US SHIP mailing lists concerning the dates and general procedure of the House of Delegates Meeting.

(e) The proposed changes, together with the names of the proponents and supporting statements, will be compiled by APHIS and distributed. When two or more similar changes are submitted, APHIS will endeavor to unify them into one proposal acceptable to each proponent. Copies will be distributed to officials of the Official State Agencies cooperating in the US SHIP. Additional copies will be made available for meeting individual requests.

§?149.5 Official Delegates.

Each cooperating State shall be entitled to one or more official delegates. The official delegates shall be elected by a representative group of participating industry members and be certified by the Official State Agency. It is recommended, but not required, that the official delegates be Plan participants. Each official delegate shall endeavor to obtain, prior to the House of Delegates conference, the recommendations of industry members of their State with respect to each proposed change. Official delegate allocations for cooperating States will be calculated in accordance with the methods described in the US SHIP Program Standards. Changes to these methods will be made in accordance with §?149.9.

§?149.6 Committee Consideration of proposed changes.

(a) The following committees shall be established to give preliminary consideration to the proposed changes falling in their respective fields:

(1) Biosecurity.

(2) Traceability.

[top] (3) Sampling and Testing.

(b) The committees must discuss related proposals with other committees.

(c) The committees shall make recommendations to the House of Delegates as a whole concerning each proposal. The House of Delegates report shall show any proposed change in wording, record the votes on each proposal, and suggest an effective date for each proposal recommended for adoption. The individual committee reports shall be submitted to the chairperson of the House of Delegates, who will combine them into one report showing, in numerical sequence, the committee recommendations on each proposal. Once completed, the combined committee report will be distributed electronically to the Official State Agencies prior to the delegates voting on the final day of the House of Delegates conference.

(d) The Technical Committee meetings shall be open to any interested person. Advocates for or against any proposal may appear before the appropriate committee and present their views.

§?149.7 House of Delegates consideration of proposed changes.

(a) The chairperson of the House of Delegates shall be a representative of the Department.

(b) At the time designated for voting on proposed changes by the official delegates, the chairman of the General Conference Committee and all committee chairpersons shall sit at the speaker's table and assist the chairperson of the House of Delegates.

(d) Proposals that have not been submitted in accordance with §?149.5 will be considered by the House of Delegates only with the unanimous consent of the General Conference Committee. Any such proposals must be referred to the appropriate committee for consideration before being presented for action by the House of Delegates.

(e) Voting will be by States, and each official delegate, as determined by §?149.5, will be allowed one vote on each proposal pertaining to the program prescribed by the subpart which they represent.

(f) A roll call of States for a recorded vote will be used when requested by a delegate or at the discretion of the chairman.

(g) All motions on proposed changes shall be for adoption.

(h) Proposed changes shall be adopted by a two-thirds majority vote of the official delegates present and voting.

(i) The House of Delegates conference shall be open to any interested person.

§?149.8 Approval of House of Delegates recommendations by the Department.

Proposals adopted by the official delegates will be recommended to the Department for incorporation into the provisions of the US SHIP in part 148 of this subchapter and this part. The Department reserves the right to approve or disapprove the recommendations of the House of Delegates as an integral part of its sponsorship of the US SHIP.

§?149.9 Changes to the US SHIP Program Standards.

The US SHIP Program Standards document contains content on the testing requirements for diseases covered by the regulations in part 148 of this subchapter, approved procedures for maintaining biosecurity at participating swine operations, traceability requirements for participating swine operations, and calculations for official delegate allocations. Changes to the US SHIP Program Standards document for any of the foregoing will be made in the following manner:

(a) Normal process for updating the US SHIP Program Standards document. (1) APHIS will publish a notice in the Federal Register providing the proposed changes to the US SHIP Program Standards document and the basis for the changes. The notice will request public comment.

(2) If no comments are received on the notice, or if the comments received do not call into question the basis for the changes, APHIS will publish a subsequent notice in the Federal Register announcing that the changes have been made to the US SHIP Program Standards document and making available the revised US SHIP Program Standards document. If comments identify concerns with the proposed revisions, APHIS will consider and address those comments as appropriate prior to taking any action to revise the US SHIP Program Standards.

(b) Process for making immediate changes to the US SHIP Program Standards document. (1) If the Administrator determines that procedures for maintaining biosecurity and animal traceability at participating swine operations that are described in the US SHIP Program Standards document are not adequate or that testing procedures must be revised in order to ensure that they provide reliable assurances regarding test results, APHIS will make the relevant change to the US SHIP Program Standards document. As soon as is feasible, APHIS will publish a notice in the Federal Register announcing the change, as well as the basis for the change. The notice will request public comment.

(2) APHIS may make further revisions to the US SHIP Program Standards document based on the comments received.

Done in Washington, DC, this 23rd day of December 2024.

Donna Lalli,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 2024-31386 Filed 12-30-24; 8:45 am]

BILLING CODE 3410-34-P