`[Federal Register Volume 89, Number 250 (Tuesday, December 31, 2024)]
[Proposed Rules]
[Pages 107045-107063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31386]



[[Page 107045]]

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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.

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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; [email protected].

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.
    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

[[Page 107046]]

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 Sec. Sec.  148.1 through 148.11 and provide the general 
structure for participation in US SHIP.

Definitions (Sec.  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.
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    \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.
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    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 Sec.  148.7 of the regulations to collect official 
samples for submission to an authorized laboratory in accordance with 
Sec.  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 Sec.  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.
    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

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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.
    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.

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    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 (Sec.  148.2)

    Proposed Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  148.2(d) would provide that laboratories authorized 
in accordance with proposed Sec.  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 Sec.  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 (Sec.  148.3)

    Proposed Sec.  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 Sec.  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.
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    \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/.
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    Proposed Sec.  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 Sec.  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 Sec.  148.2. This provision is modeled on NPIP.
    Proposed Sec.  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 Sec.  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\
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    \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/.
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    Proposed Sec.  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 Sec.  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.
    Proposed Sec.  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

[[Page 107049]]

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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 (Sec.  148.4)

    Proposed Sec.  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 Sec.  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 Sec.  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 Sec.  148.8(b) and any additional requirements by 
the Official State Agency. This provision is also modeled on NPIP.
    Proposed Sec.  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 Sec.  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 (Sec.  148.5)

    Proposed Sec.  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 Sec.  148.5(a) would provide that participants may only 
use the classification terms listed in proposed Sec.  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.
    Proposed Sec.  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.

[[Page 107050]]

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

    Proposed Sec.  148.6 would outline terminology and classifications 
for herds, products, and States within US SHIP.
    Proposed Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  148.11, 
only NAHLN laboratories have the necessary equipment and expertise to 
perform the required tests for ASF and CSF in swine.
    Proposed Sec.  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 Sec.  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 Sec.  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 (Sec.  148.7)

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

[[Page 107051]]

opportunity to present their views. This provision is modeled on 
similar provisions in Sec.  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 (Sec.  148.8)

    Proposed Sec.  148.8 would discuss maintenance of certification 
within US SHIP. Proposed Sec.  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 Sec.  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 Sec.  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 (Sec.  148.9)

    Proposed Sec.  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 (Sec.  148.10)

    Proposed Sec.  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 Sec.  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 (Sec.  148.11)

    Proposed Sec.  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

[[Page 107052]]

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 Sec. Sec.  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 (Sec.  148.21)

    Proposed Sec.  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 Sec.  146.31 of the NPIP regulations, with appropriate 
modifications to reflect the nature of the swine industry.

Participation (Sec.  148.22)

    Proposed Sec.  148.22(a) would require participating slaughter 
facilities to comply with the general provisions of Sec.  148.4 of the 
regulations as well as the slaughter facility-specific provisions of 
subpart B.
    Proposed Sec.  148.22(b) would require participating slaughter 
facilities to supply the information outlined in Sec.  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 Sec.  148.3(d)(5), slaughtering 
facilities should provide expected slaughter capacity (number of swine 
slaughtered daily/weekly).

Terminology and Classification; Slaughtering Facilities (Sec.  148.23)

    Proposed Sec.  148.23 discusses terminology and classification for 
slaughtering facilities within US SHIP.
    Proposed Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec. Sec.  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 (Sec.  149.1)

    Proposed Sec.  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.
    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.

[[Page 107053]]

    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 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 
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 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 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 Sec.  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.
    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.

General (Sec.  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 (Sec.  149.3)

    Proposed Sec.  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 Sec.  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.
    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

[[Page 107054]]

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 Sec.  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 Sec.  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 Sec.  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 Sec.  149.5.
    Proposed Sec.  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 Sec.  149.3(d) would outline the duties of the GCC. 
Proposed Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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.
    Proposed Sec.  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

[[Page 107055]]

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 Sec.  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 Sec.  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 (Sec.  149.4)

    Proposed Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 (Sec.  149.5)

    Proposed Sec.  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 Sec.  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 (Sec.  149.6)

    Proposed Sec.  149.6 would outline rules for the formation of 
committees and consideration of proposed changes to the regulations or 
US SHIP Program Standards.
    Proposed Sec.  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 Sec.  149.6(b) provides that the committees must discuss 
related proposals with other committees.
    Proposed Sec.  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 Sec.  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 (Sec.  149.7)

    Proposed Sec.  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.
    Proposed Sec.  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

[[Page 107056]]

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 Sec.  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 Sec.  149.7(d) would state that proposals that have not 
been submitted in accordance with Sec.  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 Sec.  149.7(e) would state that voting will be by States, 
and each official delegate, as determined by Sec.  149.5, will be 
allowed one vote on each proposal. This provision is drawn from the US 
SHIP pilot program.
    Proposed Sec.  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 Sec.  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 Sec.  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 Sec.  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 (Sec.  
149.8)

    Proposed Sec.  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 (Sec.  149.9)

    Proposed Sec.  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 Sec.  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 Sec.  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

    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

[[Page 107057]]

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 [email protected] 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.

0
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.


Sec.  148.1  Definitions.

    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

[[Page 107058]]

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 Sec.  148.7 to 
collect official samples for submission to an authorized laboratory in 
accordance with Sec.  148.10.
    Authorized laboratory. A laboratory that meets the requirements of 
Sec.  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.


Sec.  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 Sec.  148.11 will 
conduct diagnostic testing when determining the status of a 
participating herd with respect to official Plan classifications.


Sec.  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 Sec.  148.2.
    (b) Any person producing or dealing in swine or pork products may

[[Page 107059]]

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 Sec.  
148.2.
    (c) Each participant shall comply with the Plan until released by 
such Agency.
    (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 Sec.  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.


Sec.  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 Sec.  
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.


Sec.  148.5  Terminology and classification; general.

    (a) The official classifications provided in Sec.  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.


Sec.  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.
    (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 Sec.  
148.11 and using

[[Page 107060]]

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 Sec.  149.9 of this subchapter.


Sec.  148.7  Supervision.

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


Sec.  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.


Sec.  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]


Sec.  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 Sec.  148.11. 
Procedures for testing shall be described in the Program Standards. 
Changes to these procedures will be made in accordance with Sec.  149.9 
of this subchapter.


Sec.  148.11  Authorized Laboratories.

    In order to be authorized to conduct testing as provided for in 
Sec.  148.10, laboratories must be approved by APHIS in accordance with 
Sec.  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


Sec.  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.


Sec.  148.22  Participation.

    (a) Participating slaughtering facilities shall comply with the 
provisions in Sec.  148.4 and the special provisions of this subpart.
    (b) Except for the information required in Sec.  148.3(d)(5), 
participating slaughtering facilities shall provide the same 
information required for other participants as outlined in Sec.  
148.3(d). For purposes of complying with Sec.  148.3(d)(5), 
slaughtering facilities must provide expected slaughter capacity 
(number of swine slaughtered daily/weekly).


Sec.  148.23  Terminology and classification; slaughtering facilities.

    (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,

[[Page 107061]]

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.


Sec.  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.
    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.
    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;
    (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 part 148 of this subchapter and this part.
    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.
    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.
    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.


Sec.  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.


Sec.  149.3  General Conference Committee.

    (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

[[Page 107062]]

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 
Sec.  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.


Sec.  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.


Sec.  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 Sec.  149.9.


Sec.  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.
    (3) Sampling and Testing.

[[Page 107063]]

    (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.


Sec.  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.
    (c) The chairperson shall set the rules of order for the General 
Conference Committee.
    (d) Proposals that have not been submitted in accordance with Sec.  
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 Sec.  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.


Sec.  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.


Sec.  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`