National Poultry Improvement Plan and Auxiliary Provisions

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Proposed rule.

SUMMARY:

We are proposing to amend the regulations governing the National Poultry Improvement Plan (NPIP). These amendments would, among other things, condition indemnity for low pathogenicity avian influenza on adherence to biosecurity plans, clarify existing provisions of the regulations, fix editorial errors, and align the regulations more closely with current producer practices. These proposed changes were voted on and approved by the voting delegates at the NPIP's 2022 National Plan Conference.

DATES:

We will consider all comments that we receive on or before August 12, 2024.

ADDRESSES:

You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to www.regulations.gov. Enter APHIS-2022-0056 in the Search field. Select the Documents tab, then select the Comment button in the list of documents.
• Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2022-0056, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238.

Supporting documents and any comments we receive on this docket may be viewed at www.regulations.gov or in our reading room, which is located in room 1620 of the USDA South Building, 14th Street and Independence Avenue SW, Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 7997039 before coming.

FOR FURTHER INFORMATION CONTACT:

Dr. Elena Behnke, DVM, Senior Coordinator, National Poultry Improvement Plan, VS, APHIS, USDA, 1506 Klondike Road, Suite 301, Conyers, GA 30094-5104; (770) 922-3496.

SUPPLEMENTARY INFORMATION:

Background

The National Poultry Improvement Plan (NPIP, also referred to below as “the Plan”) is a cooperative Federal-State-industry mechanism for controlling certain poultry diseases. The Plan consists of a variety of programs intended to prevent and control poultry diseases. Participation in all Plan programs is voluntary, but breeding flocks, hatcheries, and dealers must first qualify as “U.S. Pullorum-Typhoid Clean” as a condition for participating in the other Plan programs.

The Plan identifies States, independent flocks, hatcheries, dealers, and slaughter plants that meet certain disease control standards specified in the Plan's various programs. As a result, customers can buy poultry that has tested clean of certain diseases or that has been produced under disease-prevention conditions.

The regulations in 9 CFR parts 56, 145, 146, and 147 (referred to below as the regulations) contain the provisions of the Plan. The Animal and Plant Health Inspection Service (APHIS) amends these provisions from time to time to incorporate new scientific information and technologies within the Plan, and to ensure the plan reflects changes to the poultry industry itself. The changes we are proposing, which are discussed below, were approved by the voting delegates at the Plan's 2022 Biennial Conference. Participants and voting delegates at the Biennial Conference represented the poultry industry, flock owners, breeders, hatchery men, slaughter plants, poultry veterinarians, diagnostic laboratory personnel, Official State Agencies from cooperating States, and other poultry industry affiliates.

In this document, we first discuss editorial oversights from the last rulemaking to update the NPIP regulations that we are proposing to correct in this proposed rule. Then, we address the other proposals, in the order in which they would appear in the regulations. Finally, we discuss proposed changes to the Program Standards document that accompanies the regulations and provides guidance on their application.

Editorial Oversights From the Previous Rulemaking

On October 5, 2020, we published a final rule in the Federal Register (85 FR 62559-62572, Docket No. APHIS-2018-0062) that codified changes to the regulations that were voted on and approved by the voting delegates at the NPIP's 2018 National Plan Conference.

Among the changes to the regulations in that October 2020 final rule were revisions to the regulations in part 56, which govern the payment of indemnity for low pathogenicity avian influenza (LPAI). As one of these revisions, we intended to revise references to cleaning and disinfection for LPAI to “virus elimination” throughout part 56, or otherwise add the term “virus elimination” after references to cleaning and disinfection. As we stated in the proposed rule on which the October 2020 final rule was based, “virus elimination” is the term used in many foreign countries for cleaning and disinfection measures conducted to destroy or eliminate all LPAI virus on an affected premises, and we wished to underscore the restrictive sense in which cleaning and disinfection was being used in the regulations in part 56.

However, while we updated the terminology in several sections in part 56, we inadvertently overlooked instances in §§ 56.3 and 56.5 in which the terminology was not updated. We propose to add references to virus elimination in these two sections.

In the October 2020 final rule, we added provisions throughout the regulations for a U.S. Newcastle Disease Clean classification. Our intent was to indicate that, for that classification, a minimum of 30 birds per flock must test negative using an approved test at intervals of 90 days, or, alternatively, a sample of fewer than 30 birds may be tested, and found negative, at any one time if all pens are equally represented and a total of 30 birds is tested within each 90-day period, and, regardless of which of the two foregoing testing options is chosen, during each 90-day period, all primary spent fowl, up to a maximum of 30, must test negative within 21 days prior to movement. However, due to the punctuation used for these provisions, they could be construed to mean that primary spent fowl testing is optional depending on the flock testing protocol used. This was not our intent, and we are revising the Newcastle Disease Clean classification provisions throughout the NPIP regulations to align them with our intent.

In the October 2020 final rule, we added a subpart J to part 145 of the regulations, which added testing regimes, terminology, and programs specifically designed for the game bird industry. However, in several instances where sections or subparts are listed within the regulations, we inadvertently neglected to update the lists to include references to this new subpart J. We are correcting this oversight throughout part 145.

In adding subpart J to part 145, we stated, in paragraph (e) of § 145.102, that it was recommended that gallinaceous flocks that participate in the plan and waterfowl be kept separate. However, our definition of the term game bird in § 145.101 indicated that it was limited to domesticated fowl; this would preclude a producer who has waterfowl on the same premises from participating under the regulations in subpart J. We are revising paragraph (e) to clarify that gallinaceous flocks and waterfowl may not be raised on the same premises, and, if they are, they must be registered under subpart E of part 145 instead. This subpart contains provisions of the plan specifically designed for producers of hobbyist poultry, exhibition poultry, and raised-for-release waterfowl.

In § 145.103 of subpart J, we included a typographical error in which the word “Typhoid” was misspelled “Typhid.” We are correcting this misspelling.

Subpart E of part 146 of the regulations contains definitions and requirements for Plan participants within the game bird, commercial waterfowl, and raised-for-release waterfowl industries who produce meat- or egg-type flocks. In the proposed rule on which the October 2020 final rule was based, we proposed to update the terminology in subpart E to match other subparts within part 146 by replacing the term “commercial” with “egg/meat-type.” However, we neglected to make corresponding changes to §§ 146.3, 146.6, and 146.9, which contain references to the types of commercial flocks that may participate in the plan under the provisions in part 146. We also neglected to make a similar harmonizing change in paragraph (a)(9) of § 147.46. We are correcting these oversights by harmonizing the language accordingly.

Proposed Revisions to Part 56

As we mentioned above, the regulations in part 56 govern the payment of indemnity for LPAI. Section 56.1 contains definitions of terms used within that part. We are proposing several revisions to this section. First, we are proposing to add a definition of the National Poultry Improvement Plan (NPIP) Program Standards. As we do in § 145.1 of the NPIP regulations, we propose to define the term as “A document that contains tests and sanitation procedures approved by the Administrator pursuant to § 147.53 of this chapter.” Also consistent with that definition in § 145.1, the proposed definition would further specify how the Program Standards may be obtained. The regulations in part 56 currently do not refer to the NPIP Program Standards, however, as discussed below, we are proposing to add references to them and consider a definition warranted in light of those proposed additions.

Currently, § 56.1 defines Virus elimination (VE) as “Cleaning and disinfection measures conducted to destroy or eliminate all AI virus on an affected premises.” However, virus elimination may also include methods such as fallowing for premises with dirt floors. To reflect this, we are proposing that virus elimination be defined as “Cleaning and disinfection or other measures conducted to destroy or eliminate all AI virus on the premises.”

Currently, paragraph (b) of § 56.3 provides that the Administrator of APHIS is authorized to pay 100 percent of costs and/or compensation for activities listed in paragraphs (a)(1) through (3) of the section, except for poultry that are described by the categories in the subparagraphs of paragraph (b). The section further specifies that the Administrator may only pay 25 percent of costs for infected or exposed poultry described in any of those categories.

However, the categories in these subparagraphs, in certain instances, currently contain double negatives, which could make it difficult for producers to ascertain whether they qualified for 100 percent or 25 percent of the listed activities for which cost or compensation may be paid. To assist in readability, we are restructuring the introductory text of paragraph (b) so that it provides that producers meeting the conditions in paragraphs (b)(1) or (2) would be eligible for 100 percent of costs and/or compensation, and we are restructuring these subparagraphs so that they contain positive conditions that must be met in order to be eligible for 100 percent indemnification. Finally, we are adding paragraph (b)(3) which would articulate the categories that are eligible for 25 percent, rather than 100 percent. Again, it is not our intent in these revisions to change the eligibility requirements, but simply to make them easier to interpret. To that end, in the regulatory text at the end of this document, we lay out our proposed revision to paragraph (b) in its entirety for ease of readability and public comment. We also request specific public comment regarding whether there is a different structure for the section that would be clearer and more readable than our proposed revisions.

Section 56.5 contains provisions regarding destruction and disposal of poultry, as well as cleaning and disinfection (virus elimination) of premises, conveyances, and materials. Within that section, paragraph (c) contains provisions regarding the conditions under which infected or exposed poultry for H5/H7 LPAI may be controlled marketed, rather than depopulated, at the discretion of the cooperating State agency and APHIS. The requirements provide that:

• Poultry infected with or exposed to H5/H7 LPAI must not be transported to a market for controlled marketing until approved by the Cooperating State Agency in accordance with the initial State response and containment plan, which is described in § 56.10 of the regulations.
• Within 7 days prior to slaughter, each flock to be moved for controlled marketing must be tested for H5/H7 LPAI using a test approved by the Cooperating State Agency and found to be free of the virus.
• Routes to slaughter must avoid other commercial poultry operations whenever possible. All load-out equipment, trailers, and trucks used on the premises that have housed poultry must undergo virus elimination procedures and not enter other poultry premises or facilities for 48 hours after the virus elimination procedures have been completed.
• Flocks moved for controlled marketing must be the last poultry marketed during the week they are marketed.

We are proposing to add an additional requirement, that the poultry must be monitored daily for the development of additional and/or increased severity of clinical signs with scheduled flock observation, tracking, and recording flock(s) mortality, taking action as directed by the Official State Agency. We consider this provision necessary because controlled marketing permits the movement of birds known to be infected with or exposed to disease, and because poultry that initially present symptoms consistent with LPAI may subsequently present symptoms associated with a disease with more acute morbidity, such as HPAI. Daily monitoring and coordination with the Official State Agency is therefore appropriate to address this possible risk. To that end, in the regulatory text at the end of this document, we lay out this new provision in its entirety as proposed paragraph (c)(1)(ii) of § 56.5.

Section 56.10 sets forth requirements for initial State response and containment plans for LPAI. Among the current requirements for initial State response and containment plans is that a minimum biosecurity plan must be followed by all poultry producers in the State as indicated in paragraph (a)(2). We are proposing to revise this requirement in several manners. First, as articulated in § 56.3, a biosecurity plan is not required of all producers as a condition for LPAI indemnity, but rather those meeting certain size thresholds. As a result, we would clarify that the initial State response and containment plan must require biosecurity plans for poultry producers based on their flock size as articulated in § 56.3, and, if applicable, contracting parties with such producers.

Second, our experience with avian influenza outbreaks, most notably the highly pathogenic avian influenza (HPAI) outbreak of 2022 and 2023, has suggested that the requirement needs a mechanism to ensure that the biosecurity plans are in fact being followed. As a result, we would amend the requirement for biosecurity plans to specify that the Official State Agency must determine that they are in place and being followed within the State. Likewise, we would specify that the Official State Agency must audit the plans for compliance with the biosecurity principles approved by the Administrator. These revisions would, in turn, authorize Official State Agencies to take on a role of greater oversight within their State regarding the implementation and maintenance of biosecurity plans. Finally, we would provide that the Program Standards document, particularly Standard E, contains the biosecurity principles approved by the Administrator. To that end, in the regulatory text at the end of this document, we lay out our proposed revision to § 56.10 in its entirety for ease of readability and public comment.

Proposed Revisions to Part 145

Section 145.1 of the regulations provides general definitions of terms used within the NPIP regulations. We are proposing several revisions to this section.

Currently, the definition for Fowl typhoid or typhoid is “a disease of poultry caused by Salmonella gallinarum,” and the definition for Pullorum disease or pullorum is “A disease of poultry caused by Salmonella pullorum.” However, since these definitions were added to the regulations, the accepted nomenclature for Salmonella spp. has changed, and Salmonella is now classified with greater specificity: Not only by species, but also by subspecies, serovar, and biovar. Moreover, it is that specific pathogenic biovar that the NPIP regulations refer to, rather than Salmonella species in the broad sense. We are proposing to update the definitions for Fowl typhoid or typhoid and Pullorum disease or pullorum accordingly.

The definition for Hatchery currently is “Hatchery equipment on one premises operated or controlled by any person for the production of baby poultry.” However, hatcheries, such as incubation facilities, may be devoted solely to the production of embryonated eggs. We are updating the definition accordingly.

Likewise, the definition for Multiplier breeding stock is “A flock that is intended for the production of hatching eggs used for the purpose of producing progeny for commercial egg or meat production or for other nonbreeding purposes.” However, breeding stock may include fertile eggs, even if the eggs are not yet hatching. We would remove the word “hatching” and add the word “fertile” in its place.

The definition for Reactor currently provides that a reactor is a bird that has a positive reaction to a test, required or recommended in this part or in accordance with the NPIP regulations in 9 CFR part 147, for any poultry disease for which a program has been established within the NPIP. Currently, § 145.14 of the regulations specifies that reactors are considered suspects under the regulations until additional confirmatory testing has been conducted in accordance with the regulations; however, the definition of Reactor does not refer to this provision. As a result, we are proposing to amend the definition of Reactor to include the provision that confirmatory testing must be conducted before a suspect is reclassified as a reactor.

Finally, we are proposing to add a definition of Salmonella Enteritidis. Provisions for a Clean program for Salmonella Enteritidis exist within the regulations, but the term is not currently defined. We are proposing to define it as “A bacteria found in poultry caused by Salmonella enterica subspecies enterica serovar Enteritidis (Salmonella Enteritidis).”

Section 145.10 of the regulations contains illustrative designs of emblems that flocks and products may be designated with based on their participation in various provisions of the Plan. While the regulations currently provide for a U.S. Newcastle Clean program, U.S. Avian influenza clean compartments, and U.S. Newcastle clean compartments, there are not currently corresponding illustrative designs for this program and these compartments in § 145.10. We propose to add illustrative designs for them.

Section 145.14 contains poultry testing requirements within the NPIP. We are proposing a number of revisions to the section.

The introductory text to the section currently indicates that, for plan programs in which a representative sample may be tested in lieu of an entire flock, the minimum number tested shall be 30 birds per house, unless otherwise specified within the Plan program, with at least 1 bird taken from each pen and unit in the house testing. The sentence further specifies that this does not apply for the ostrich emu, rhea, and cassowary program set forth in § 145.63(a) of the regulations.

The intent of the sentence is to direct producers, including those ostrich, emu, rhea, and cassowary producers enrolled in the program set forth in § 145.63, to the relevant testing requirements for their program(s), and then provides general requirements for test samples within the context of those specific program testing requirements. However, the sentence could be read to indicate that it is of general applicability except in certain outlying situations when program testing requirements indicate otherwise. Moreover, the sentence could be construed to mean either that it sets forth minimum testing requirements for ostrich, emu, rhea, and cassowary producers enrolled in the program set forth in § 145.63(a), while all other producers should follow program testing requirements, or that it does not apply to ostrich, emu, rhea, and cassowary producers at all, who should instead follow the requirements of § 145.63. We are proposing to revise the sentence to clarify its intent.

Paragraph (a)(1) provides the official blood tests that may be used for Pullorum-Typhoid within the program, and specifies that the tests must be conducted in accordance with part 147 of the regulations. Guidance and policy related to testing is also found within Program Standards document, in Program Standard A, however. We would indicate that Program Standard A is also operative when conducting testing.

Paragraph (a)(6) specifies the manner in which poultry from flocks undergoing qualification testing for participation in the NPIP that have a positive reaction to an official blood test must be subsequently evaluated. Among other provisions, it specifies that, when reactors are submitted to an authorized laboratory within 10 days of the date of reading of the official blood test, and the bacteriological examination fails to demonstrate pullorum-typhoid infection, the Official State Agency shall presume that the flock has no pullorum-typhoid reactors. However, if poultry from the flock has had a non-negative reaction to an official blood test for pullorum-typhoid, by definition it is a reactor for pullorum-typhoid, and the culture from the bacteriological examination is intended to ascertain whether the poultry is affected with Salmonella Pullorum or Salmonella Gallinarum, not whether it has reacted to a pullorum-typhoid test. It already has so reacted by the time of the culture.

As a result, we would clarify that if the bacteriological examination and culture fails to demonstrate pullorum-typhoid infection, the Official State Agency may determine that the flock is not infected with Salmonella Pullorum or Salmonella Gallinarum, but the poultry are still pullorum-typhoid reactors.

Section 145.33 sets forth terminology and classification provisions for multiplier meat-type chicken breeding flocks and their products, while § 145.43 sets forth terminology and classification provisions for turkey breeding flocks and their products. Both sections currently contain provisions for a U.S. Sanitation monitored program for the prevention and control of Salmonellosis. In both sections, the relevant programs allow owners of flocks found infected with paratyphoid Salmonella to vaccinate the flocks with an autogenous bacterin with a potentiating agent. However, the testing for Salmonella specified in the programs is environmental testing, rather than flock testing; if the environmental testing in the section has a non-negative test for Salmonella spp. it does not necessarily mean the flock itself is infected, and the flock may, accordingly, be vaccinated for Salmonella typhoid irrespective of the environmental testing. We are proposing to delete the current vaccination allowance because it is not germane to the programs; producers may choose to vaccinate their flocks for Salmonella typhoid or not with no bearing on the programs' provisions.

Paragraph (l) of § 145.33 sets forth a U.S. Avian Influenza clean program for multiplier meat-type chicken breeding flocks and their products. Paragraph (l)(1) currently requires either a sample of at least 15 birds to be tested negative at intervals of 90 days; or a sample of fewer than 15 birds to be tested, and found to be negative, at any one time if all pens are equally represented and a total of 15 birds is tested within each 90-day period; or the flock to be tested at intervals of 30 days or less and found to be negative, and a total of 15 samples are collected and tested within each 90-day period. Paragraph (l)(2) of the section currently specifies that, during each 90-day period, all multiplier spent fowl, up to a maximum of 30, must be tested and found negative for avian influenza within 21 days prior to movement to slaughter. As written, paragraph (l)(2) could be construed to allow one multiplier spent fowl to be tested within 21 days prior to movement, and to allow this testing to count towards the requisite testing in paragraph (l)(1). This would constitute insufficient testing for avian influenza to provide assurances that a flock is “clean,” however. Accordingly, we are proposing to remove paragraph (l)(2) and require instead that 15 birds are tested and found negative for avian influenza within 21 days prior to movement to slaughter regardless of the date of the previous test. This would align the minimum testing sample for multiplier spent fowl with the minimum test sample requirements for the flock as a whole.

Paragraph (m) of § 145.33 sets forth a U.S. Salmonella Enteritidis Monitored program for multiplier meat-type breeders wishing to monitor their flocks. Paragraph (m)(2) provides actions that must be taken with respect to test results generated from the monitoring program. When the program was first added to § 145.33, the section pertained to both primary meat-type breeders and multiplier meat-type breeders, and the provisions in paragraph (m)(2) specifically addressed primary breeders. However, primary breeders now have their own subpart, subpart H, within the regulations. For multiplier meat-type breeders, because the offspring of the breeders rather than the breeders themselves enter commercial production, it is sufficient for the participating breeder to have a monitoring and testing program in place for Salmonella enteritidis, with the appropriate actions following test results determined by the breeders themselves. In other words, it is the existence of the monitoring program, rather than the results of testing conducted under the auspices of the monitoring program, that results in the classification for multiplier meat-type breeders. We propose to amend paragraph (m)(2) accordingly.

As we mentioned above, § 145.43 sets forth terminology and classification provisions for turkey breeding flocks and their products. Paragraph (c) of the section contains provisions for U.S. M. Gallisepticum Clean status for such flocks and products, while paragraph (d) contains provisions for U.S. M. Meleagridis Clean status, and paragraph (e) contains provisions for

M. Synoviae Clean status. All three paragraphs contain separate testing protocols for male flocks and female flocks, but no protocols for mixed flocks of male and female turkeys. We propose to add such protocols.

Paragraph (c)(1) of § 145.43 also indicates that testing must find no M. Gallisepticum reactors as one of the conditions for clean status. However, as noted previously, a reactor is, by definition, not necessarily a positive sample, but rather a suspect that has been sent for additional confirmatory testing by an authorized laboratory or Federal Reference laboratory. If the confirmatory testing comes back negative, the sample is cleared. We propose to amend paragraph (c)(1) so that the testing would instead have to find no M. Gallisepticum infected birds.

Paragraph (d)(5) of § 145.43 contains a typo that we would correct; it refers to “block” when contextually “flock” is meant.

Section 145.53 sets forth terminology and classification provisions for hobbyist and exhibition poultry, as well as raised-for-release waterfowl, breeding flocks and their products. Within the section, paragraph (e) contains provisions for a U.S. H5/H7 Avian Influenza Clean classification for such poultry and products. That paragraph currently states that the classification pertains to hobbyist or exhibition waterfowl, exhibition poultry, and game bird poultry and products. However, as noted above, the section does not pertain to exhibition waterfowl or game birds. We propose to amend paragraph (e) accordingly to remove such references.

Section 145.73 sets forth terminology and classification provisions for egg-type chicken breeding flocks and their products. Paragraph (d) contains provisions for U.S. S. Enteritidis Clean classification for such flocks and products. Within paragraph (d), paragraph (d)(1)(i) currently requires either that a flock originates from a U.S. S. Enteritidis Clean flock, or meconium from the chick boxes and a sample of chicks that died within 7 days after hatching are examined bacteriologically for salmonella at an authorized laboratory, and cultures from positive samples are serotyped, as a condition of classification. Contextually, the paragraph is referring to samples that are positive for serogroup D of salmonella. We propose to revise the paragraph to make it clear that this was the relevant serogroup being referenced.

Paragraph (g) of § 145.73 contains provisions for U.S. Salmonella Monitored status for egg-type chicken breeding flocks and their products, while paragraph (f) of § 145.83 contains provisions for primary meat-type breeding flocks and their products. In both sections of the regulations, we currently require, among other things, that an Authorized Agent take environmental samples from each flock at 4 months of age and every 30 days thereafter; that an authorized laboratory for Salmonella examine the environmental samples bacteriologically; and that all Salmonella isolates from a flock be serogrouped and be reported to the Official State Agency on a monthly basis. As we mentioned previously in this document, environmental testing is not the same as flock testing, and positive samples within the environment do not necessarily mean the flock itself is infected. For those reasons, reporting the results of all testing to the Official State Agency on a monthly basis is not warranted. For a monitoring program, the Official State Agency need only know whether the Salmonella is present or absent in the flocks themselves. We would amend the two sections accordingly. We would also remove references in paragraph (g) of § 145.73 and paragraph (f) of § 145.83 which could be read to suggest that the above testing is flock testing, rather than environmental testing.

Paragraph (f) of § 145.83 also provides that any flock entering the production period that is in compliance with all the paragraph, and with no history of Salmonella isolations, shall be considered “ Salmonella negative” and may retain this definition as long as no environmental or bird Salmonella isolations are identified and confirmed from the flock or flock environment by sampling on four separate collection dates over a minimum of a 2-week period. We are proposing to revise the minimum 2-week period to a maximum 4-week period.

For flocks in production, it is common to have hatching eggs set aside in hatcheries for customer orders. If salmonella isolation occurs, confirmatory testing must be timely so that a business decision can be made regarding the disposition of the eggs. Allowing four sets of confirmatory samples over a four-week period provides sufficient time for sampling to occur while not allowing the sampling interval to be open-ended, as is currently the case.

Proposed Revisions to Part 147

In § 147.52, the regulations state the minimum requirements for an APHIS authorized laboratory evaluation to ensure that they are in compliance with NPIP regulations. Paragraph (f) of that section contains reporting requires for authorized laboratories. Within that paragraph, paragraph (f)(2) currently requires Salmonella pullorum and Mycoplasma Plan disease reactors to be reported to the Official State Agency within 48 hours. However, as noted above, a reactor, by definition, is not an infected sample. Rather, it is a sample that is sent to an authorized laboratory for confirmatory testing to determine whether it is infected with disease. Accordingly, we would revise paragraph (f)(2) to require reporting of infected flocks, rather than reactors.

Proposed Revisions to NPIP Program Standards

We have also prepared updates to the NPIP Program Standards document. The proposed updates would amend several sections of the document.

We would revise the definitions section in the Program Standards document by:

• Amending the definition ofhatchery and multiplier breeding flock;
• Clarifying the definition ofreactor;
• Revising theSalmonella Pullorum, Gallinarum and Enteritidis nomenclature.

These changes would help ensure that the Program Standards are aligned with our proposed revisions to the regulations themselves.

We would revise section A, “Blood Testing Procedures,” by removing the description of how standard tube agglutination test containers should be constructed in order to be used; the current language is overly prescriptive in a manner that is not necessary for purposes of ensuring the containers can validly be used for blood testing procedures.

We would revise section B, “Bacteriological Examination Procedures,” by:

• Clarifying environmental samples are not for use to qualify or test flocks for PT Clean classification. As discussed previously in this document, environmental sampling and flock testing are distinct activities.
• Clarifying dilutions and volume of enrichment broth for the isolation and identification ofSalmonella. The current language is overly prescriptive depending on the method of dilution used.
• Allowing a temperature range for incubation and enrichment broth and pre-enrichment broth for isolation and identification ofSalmonella. The current standard specifies a specific temperature but a range in tolerance of temperatures is scientifically justified and consistent with international standards.
• Clarifying isolation and identification procedures forSalmonella by adding molecular procedures to Illustration 2. The proposed change to Illustration 2 provides visualization of the confirmation procedures.
• Removing the Hajna or Muller-Kauffman reference for selective enrichment broth for lab procedure for bacteriological examination of cull chicks and poults for Salmonella. This change is being proposed to establish a more generalized protocol rather than confining laboratories to using just two specific types of Tetrathionate broth selective enrichment.

We would revise section D, “Molecular Examination Procedures,” by:

• Clarifying the PCR grade water to use for re-suspension of the pellet before boiling in the lab procedures for PCR testing for MG and MS.
• AddingSalmonella spp. qPCR to the list of approved molecular examination procedures
• Adding new diagnostic tests to the approved molecular examination procedures.

We would revise section E, “Biosecurity Principles,” to include provisions referenced in our above discussion of the proposed revisions to § 56.10.

In addition, in § 147.53 of the regulations, we set forth the process for updating the approved tests and sanitation procedures located in the Program Standards document. In that section, we indicate that when the Administrator approves a new test or sanitation procedure or a change to an existing test or sanitation procedure, APHIS will publish a notice in the Federal Register making available the test or sanitation procedure, and that this notice will take public comment. With regard to proposed changes to an existing test or sanitation procedure, it is our intent that in the future we would only seek public comment through a Federal Register notice when the change would be a substantive change to the test or sanitation procedure that materially changes how the existing test or sanitation procedure is to be conducted. If the changes are non-substantive clarifications or remove strictures to allow for additional means of conducting the procedure, this change would not follow the process set forth in § 147.53 of the regulations and would be communicated to the public through other means available to the Agency. We feel public comment through a Federal Register notice is not warranted in these situations because parties following the existing procedures would be able to continue to do so.

Updates to Control Numbers

Finally, we are updating the Office of Management and Budget (OMB) control numbers for certain sections to reflect that OMB control number 0579-0474 expired and the associated paperwork burden (the reporting, recordkeeping, and third-party disclosure requirements) was added to OMB control number 0579-0007. In addition, where necessary, we are also adding reference to OMB control number 0579-0440.

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.

This rulemaking would result in various changes to regulations in 9 CFR parts 56, and 145 through 147, modifying provisions of the NPIP. The modifications are recommended by the NPIP General Conference Committee (GCC), which represents cooperating State agencies and poultry industry members and advises the Secretary on issues pertaining to poultry health. These amendments would, among other things, condition indemnity for low pathogenicity avian influenza on adherence to biosecurity plans, clarify existing provisions of the regulations, fix editorial errors, and align the regulations more closely with current producer practices.

These changes would align the regulations with international standards and make them more transparent to APHIS stakeholders and the general public. The changes included in this proposed rule were voted on and approved by the voting delegates at the Plan's 2022 Biennial Conference.

The establishments that would be affected by this rulemaking—principally entities engaged in poultry production and processing—are predominantly small by Small Business Administration standards. In those instances in which an addition or modification could potentially result in a cost to certain entities, we do not expect the costs to be significant. This proposed rule embodies changes decided upon by the NPIP GCC on behalf of Plan members, that is, changes recognized by the poultry industry as in their interest. We note that NPIP membership is voluntary.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action, if promulgated, 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 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 reporting, recordkeeping, and third-party disclosure requirements described in this proposed rule are currently approved by the Office of Management and Budget (OMB) under OMB control numbers 0579-0007 and 0579-0440.

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. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Mr. Joseph Moxey, APHIS' Information Collection Coordinator, at (301) 851-2533.

List of Subjects

9 CFR Part 56

• Animal diseases
• Indemnity payments
• Low pathogenic avian influenza
• Poultry

9 CFR Parts 145, 146, and 147

• Animal diseases
• Poultry and poultry products
• Reporting and recordkeeping requirements

Accordingly, we propose to amend 9 CFR parts 56, 145, 146, and 147 as follows:

PART 56—CONTROL OF H5/H7 LOW PATHOGENIC AVIAN INFLUENZA

1. The authority citation for part 56 continues to read as follows:

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

2. Amend § 56.1 by:

a. Adding in alphabetical order a definition for “National Poultry Improvement Plan (NPIP) Program Standards”; and

b. Revising the definition for “Virus elimination (VE)”.

The addition and revision read as follows:

3. Amend § 56.2 by adding an OMB citation at the end of the section to read as follows:

4. Amend § 56.3 by revising paragraphs (a)(3) and (b) and adding an OMB citation at the end of the section to read as follows:

5. Amend § 56.4 by revising the OMB citation at the end of the section to read as follows:

6. Amend § 56.5 by:

a. Redesignating paragraphs (c)(1)(ii) through (iv) as paragraphs (c)(1)(iii) through (v), respectively, and adding a new paragraph (c)(1)(ii);

b. Revising newly redesignated paragraph (c)(1)(iv); and

c. Adding an OMB citation at the end of the section.

The additions and revision read as follows:

7. Amend § 56.6 by revising the OMB citation at the end of the section to read as follows:

8. Section 56.10 is revised and republished to read as follows:

PART 145—NATIONAL POULTRY IMPROVEMENT PLAN FOR BREEDING POULTRY

9. The authority citation for part 145 continues to read as follows:

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

10. Amend part 145 by:

a. Removing “ S. gallinarum” wherever it appears and adding “ Salmonella Gallinarum” in its place;

b. Removing “ S. pullorum” wherever it appears and adding “ Salmonella Pullorum” in its place;

c. Removing “ S. enteritidis” and Salmonella enteritidis ser enteritidis” wherever they appear and adding “ Salmonella Enteritidis” in its place.

11. Amend § 145.1 by:

a. Revising the definition of “Fowl typhoid or typhoid”;

b. In the definition for “Hatchery”, adding the words “and/or embryonated eggs” after the words “baby poultry”;

c. In the definition for “Multiplier breeding flock”, removing the word “hatching” and adding the word “fertile” in its place;

d. Revising the definition of “Pullorum disease or pullorum”;

e. In the definition for “Reactor”, adding a sentence after the last sentence; and

f. Adding in alphabetical order a definition for “Salmonella Enteritidis”.

The revisions and additions read as follows:

12. Amend § 145.2 in paragraph (d) by removing the citation “§ 145.3(e)” and adding the citation “§ 145.3(f)” in its place.

13. Amend § 145.5 in paragraph (c) by removing the text “Subparts B, C, D, E, F, G, H, or I” and adding the text “Subpart B, C, D, E, F, G, H, I or J” in its place.

14. Amend § 145.10 by:

a. In paragraph (b) introductory text, removing the text “and 145.93(b)” and adding the text “145.93(b), and 145.103(b)” in its place;

b. In paragraph (g) introductory text, removing the text “and 145.94(a)” and adding the text “145.94(a), and 145.104(a)” in its place;

c. In paragraph (o) introductory text, removing the text “and 145.93(d)” and adding the text “145.93(d), and 145.103(d)” in its place;

d. In paragraph (t) introductory text, removing the text “and 145.93(c)” and adding the text “145.93(c), and 145.103(c)” in its place; and

e. Adding paragraphs (u), (v), and (w).

The additions read as follows:

15. Amend § 145.14 by:

a. Revising the introductory text;

b. In paragraph (a)(1), adding the text “(within the Program Standards document, Program Standard A applies to blood testing; alternatives to the program standards may also be approved by the Administrator under § 145.73 of this chapter)” after the word “subchapter” in the second sentence;

c. In paragraph (a)(5), removing the text “and 145.93” and adding the text “145.93, and 145.103” in its place; and

d. Revising paragraph (a)(6)(ii).

The revisions read as follows:

16. Amend § 145.33 by:

a. Removing the semicolon after paragraph (d)(1)(vii) and adding a period in its place;

b. Removing paragraph (d)(1)(viii);

c. Adding paragraph (l)(1)(iv);

d. Removing and reserving paragraph (l)(2);

e. In paragraph (m)(2)(i), adding the words “by the company” after the words “shall be conducted”; and

f. Removing and reserving paragraphs (m)(2)(ii) through (iv).

The addition reads as follows:

17. Amend § 145.43 by:

a. Revising paragraph (c)(1);

b. In paragraph (d)(1)(i), adding the words “or 60 samples, from mixed male and female flocks, (the ratio of samples collected from male and female birds must be representative of birds throughout the house)” after the words “from female flocks”;

c. Adding a reserved paragraph (d)(1)(ii);

d. In paragraph (d)(5), removing the word “block” and adding the word “flock” in its place;

e. In paragraph (e)(1), adding the words “or 60 samples, from mixed male and female flocks, (the ratio of samples collected from male and female birds must be representative of birds throughout the house)” after the words “from female flocks” in the first sentence;

f. Removing paragraph (f)(5) and redesignating paragraphs (f)(6) and (7) as paragraphs (f)(5) and (6);

g. Revising paragraph (h)(3)(i);

h. Removing paragraph (h)(3)(ii) and redesignating paragraph (h)(3)(iii) as paragraph (h)(3)(ii); and

i. Revising the OMB citation at the end of the section.

The revisions and addition read as follows:

18. Amend § 145.45 by revising the OMB citation at the end of the section to read as follows:

19. Amend § 145.53 in paragraph (e) introductory text by removing the words “hobbyist or exhibition waterfowl, exhibition poultry, and game bird” and adding the words “hobbyist and exhibition poultry, and raised-for- release waterfowl” in their place in the second sentence.

20. Amend § 145.73 by:

a. In paragraph (d)(1)(i), adding the words “serogroup D” after the words “Cultures from” in the last sentence;

b. In paragraph (g)(1)(v), removing the words “and shall be reported to the Official State Agency on a monthly basis” and adding a sentence at the end of the paragraph;

c. In paragraph (g)(1)(vi), removing the words “to allow for the serological testing required under paragraph (g)(1)(iv) of this section” and adding the words “to allow for serological testing” in their place;

d. Revising paragraph (h)(3)(i);

e. Removing paragraph (h)(3)(ii) and redesignating paragraph (h)(3)(iii) as paragraph (h)(3)(ii); and

f. Revising the OMB citation at the end of the section.

The addition and revisions read as follows:

21. Amend § 145.74 by revising the OMB citation at the end of the section to read as follows:

22. Amend § 145.83 by:

a. In paragraph (e)(6)(i)(C), removing the words “ Salmonella pullorum” and adding the words “ Salmonella Pullorum” in their place in the first sentence;

b. In paragraph (f)(1)(iv), revising the third sentence and adding a sentence at the end of the paragraph;

c. In paragraph (f)(1)(v), removing the words “to allow for the serological testing required under paragraph (f)(1)(iv) of this section” and adding the words “to allow for serological testing” in their place;

d. In paragraph (f)(1)(vi), removing the words “minimum of a 2-week period” and adding the words “maximum of a 4-week period” in their place in the first sentence;

e. Revising paragraph (h)(3)(i);

f. Removing paragraph (h)(3)(ii) and redesignating paragraph (h)(3)(iii) as paragraph (h)(3)(ii); and

g. Revising the OMB citation at the end of the section.

The addition and revisions read as follows:

23. Amend § 145.84 by:

a. In paragraph (a)(3)(iii), adding the words “and/or ND Clean” after the words “Influenza Clean”; and

b. Revising the OMB citation at the end of section.

The revision reads as follows:

24. Amend § 145.102 by revising paragraph (e) to read as follows:

25. Amend § 145.103 in paragraph (b)(3) introductory text by removing the words “to reveal Pullorum-Typhid” and adding the words “to reveal Pullorum-Typhoid” in their place.

PART 146—NATIONAL POULTRY IMPROVEMENT PLAN FOR COMMERCIAL POULTRY

26. The authority citation for part 146 continues to read as follows:

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

27. Amend part 146 by:

a. Removing “ S. gallinarum ” wherever it appears and adding “ Salmonella Gallinarum” in its place;

b. Removing “ S. pullorum ” wherever it appears and adding “ Salmonella Pullorum” in its place;

c. Removing “ S. enteritidis ” and Salmonella enteritidis ser enteritidis ” wherever they appear and adding “ Salmonella Enteritidis” in its place.

28. Amend § 146.3 by:

a. In paragraph (a), removing the words “raised-for-release upland game bird premises, and raised-for-release waterfowl premises and any commercial upland game bird, commercial waterfowl” and adding the words “egg/meat-type game bird, egg/meat-type waterfowl” in their place; and

b. In paragraph (c), removing the words “commercial upland gamebird, commercial waterfowl” and adding the words “egg/meat-type game bird, egg/meat-type waterfowl” in their place in the first sentence.

29. Amend § 146.6 by:

a. In paragraph (a), removing the words “commercial upland game bird, commercial waterfowl” and adding the words “meat-type game bird, meat-type waterfowl” in their place; and

b. In paragraph (b), removing the words “commercial upland game bird and commercial waterfowl” and adding the words “meat-type game bird and meat-type waterfowl” in their place.

30. In § 146.9 in paragraph (a) introductory text by removing the text “and (b)”.

Subpart E—Special Provisions for Egg/Meat-Type Game Birds, Egg/Meat-Type Waterfowl, Meat-Type Game Bird Slaughter Plants, and Meat-Type Waterfowl Slaughter Plants

31. Revise the subpart E heading to read as set forth above.

PART 147—AUXILIARY PROVISIONS ON NATIONAL POULTRY IMPROVEMENT PLAN

32. The authority citation for part 147 continues to read as follows:

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

33. Amend part 147 by:

a. Removing “ S. gallinarum ” wherever it appears and adding “ Salmonella Gallinarum” in its place;

b. Removing “ S. pullorum ” wherever it appears and adding “ Salmonella Pullorum” in its place;

c. Removing “ S. enteritidis ” and Salmonella enteritidis ser enteritidis ” wherever they appear and adding “ Salmonella Enteritidis” in its place.

34. Amend § 147.46 by revising paragraph (a)(9) to read as follows:

35. Amend § 147.52 by revising paragraph (f)(2) to read as follows: