Proposed Rule2024-31386
US Swine Health Improvement Plan
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 31, 2024
Issuing agencies
Agriculture DepartmentAnimal and Plant Health Inspection Service
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 250 (Tuesday, December 31, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-31386]
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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:
<bullet> Federal eRulemaking Portal: Go to <a href="http://www.regulations.gov">www.regulations.gov</a>.
Enter APHIS-2022-0061 in the Search field. Select the Documents tab,
then select the Comment button in the list of documents.
<bullet> 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 <a href="http://regulations.gov">regulations.gov</a> 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; <a href="/cdn-cgi/l/email-protection#89e5f0ede0e8a7eae8fbf9ece7fdecfbc9fcfaede8a7eee6ff"><span class="__cf_email__" data-cfemail="7f13061b161e511c1e0d0f1a110b1a0d3f0a0c1b1e51181009">[email protected]</span></a>.
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 <a href="https://www.woah.org/app/uploads/2021/03/oie-african-swine-fever-technical-disease-card.pdf">https://www.woah.org/app/uploads/2021/03/oie-african-swine-fever-technical-disease-card.pdf</a>.
\2\ APHIS (October 2023). African Swine Fever Response Plan: The
Red Book. Retrieved September 6, 2024 from, <a href="https://aphis.stg.platform.usda.gov/sites/default/files/asf-responseplan.pdf">https://aphis.stg.platform.usda.gov/sites/default/files/asf-responseplan.pdf</a>.
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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
[[Page 107047]]
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:
<bullet> Serving as Executive Secretary of the GCC;
<bullet> Serving as chairperson of the House of Delegates
conference;
<bullet> 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
<bullet> 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.
[[Page 107048]]
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 <a href="https://usswinehealthimprovementplan.com/program-documents/enrollment-documents/">https://usswinehealthimprovementplan.com/program-documents/enrollment-documents/</a>.
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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 <a href="https://usswinehealthimprovementplan.com/program-documents/enrollment-documents/">https://usswinehealthimprovementplan.com/program-documents/enrollment-documents/</a>.
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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 (<a href="https://www.aphis.usda.gov/sites/default/files/nahln-sample-chart-regulatory-submitters.pdf">https://www.aphis.usda.gov/sites/default/files/nahln-sample-chart-regulatory-submitters.pdf</a>) 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 <a href="https://aphis.usda.gov/sites/default/files/hemorrhagic-fevers-integrated-surveillance-plan.pdf">https://aphis.usda.gov/sites/default/files/hemorrhagic-fevers-integrated-surveillance-plan.pdf</a>.
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:
<bullet> Serving as Executive Secretary of the GCC;
<bullet> Serving as chairperson of the House of Delegates
conference;
<bullet> 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
<bullet> 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:
<bullet> North Atlantic: Maine, New Hampshire, Vermont,
Massachusetts, Rhode Island, Connecticut, New York, New Jersey,
Pennsylvania, Delaware, Maryland, West Virginia, Ohio, Michigan, and
Kentucky.
<bullet> East Central: Wisconsin, Indiana, Illinois, and Missouri.
<bullet> North Central: North Dakota, South Dakota, and Minnesota.
<bullet> Central: Iowa.
<bullet> South Atlantic: Virginia, North Carolina, Tennessee,
Arkansas, Louisiana, Mississippi, Alabama, Georgia, South Carolina,
Florida, and Puerto Rico.
<bullet> 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:
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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 <a href="/cdn-cgi/l/email-protection#79180911100a57090b18390c0a1d18571e160f"><span class="__cf_email__" data-cfemail="0b6a7b636278257b796a4b7e786f6a256c647d">[email protected]</span></a> 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
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</html>Indexed from Federal Register on December 31, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.