2020-21798. National Poultry Improvement Plan and Auxiliary Provisions

AGENCY:

Animal and Plant Health Inspection Service, Department of Agriculture (USDA).

ACTION:

Final rule.

SUMMARY:

We are amending the regulations governing the National Poultry Improvement Plan (NPIP). These amendments establish a U.S. Newcastle Disease Clean program within the NPIP, create an NPIP subpart specific to game birds, revise testing requirements, and clarify existing provisions of the regulations. We are also amending the regulations concerning the payment of indemnity and compensation for low pathogenic avian influenza to reflect current policy and operational practices, and allowing NPIP voting delegates to represent multiple States during the Biennial Conferences. These changes were voted on and approved by the voting delegates at the NPIP's 2018 National Plan Conference.

DATES:

Effective November 4, 2020.

FOR FURTHER INFORMATION CONTACT:

Dr. Elena Behnke, DVM, Senior Coordinator, National Poultry Improvement Plan, VS, APHIS, USDA, 1506 Klondike Road, Suite 101, Conyers, GA 30094-5104; [phone].

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.

On December 5, 2019, we published in the Federal Register (84 FR 66631-66647, Docket No. APHIS-2018-0062) a proposal ^[1] to amend the regulations by updating and clarifying several provisions, including those concerning NPIP participation, voting requirements, testing procedures, and standards.

We solicited comments concerning our proposal for 60 days, ending February 3, 2020. We received 12 comments by that date. The comments were from private citizens, a State department of agriculture, and a representative for the egg farmer industry.

Six individuals were in favor of the rule. Two individuals were generally opposed to NPIP and the poultry industry, but did not address any specific provisions of the proposed rule. The remaining comments are addressed below.

Requests for Clarification

There were three commenters who asked questions regarding the provisions of the rule but did not express favorable or unfavorable viewpoints regarding the rule. One commenter posed a number of questions regarding the provisions of the proposed rule, primarily as they pertain to game birds (for which we proposed specific provisions) and waterfowl (which have an existing subpart). First, the commenter asked how APHIS defines game birds under the proposed rule.

Under the proposed rule, game birds are domesticated fowl such as pheasants, partridge, quail, grouse, and guineas, but not doves and pigeons.

The commenter also asked if NPIP certifications would be difficult to obtain if an individual is raising waterfowl and non-waterfowl gamebirds together.

The proposed rule stated in both proposed §§ 145.52(c) and 145.102(c) that it is recommended that gallinaceous flocks and waterfowl flocks be kept separate. However, this does not preclude NPIP certifications for producers who have both flocks on the same premises. For operations that have waterfowl and game birds on the same premises, if the game birds meet the definition of “game bird” in the proposed rule, the game birds can be moved pursuant to the new gamebird-specific regulations in the proposed rule and the waterfowl remain subject to the existing NPIP regulations.

The commenter also asked if “flocksters” need to change their birds' housing to separate quarters.

“Flocksters” refers to small-scale backyard poultry producers. If the birds are covered by two different NPIP subparts, for example, those covered by subpart E of part 145 (waterfowl) and those covered by subpart J of part 145 (gamebird), and are on the same premises, the housing habitat will require separate quarters. The requirements for NPIP participation in relation to housing habitat are found in part 145 (for breeding flocks) and part 146 (for commercial flocks) and further explained in the Program Standards—Standard C Sanitation Procedures. That being said, “flocksters” should also consult the relevant size thresholds for the provisions of the regulations. For example, under part 146, “flockster” table egg layers for who intend the eggs for commercial sale and who have fewer than 75,000 birds are exempt from the provisions in that part.

The commenter also asked if raising gamebirds and non-game birds together would have any effect on NPIP testing.

The Official State Agency will work with producers in each State to determine which classification—subpart E or subpart J—is most appropriate. Birds will be tested accordingly.

The commenter also asked if designated hatcheries, breeders, and growers would need to send in or have specimens checked every 30 days under the proposed rule.

The 30-day specimen check would only apply if the participant wishes to hold the U.S. Salmonella Monitored classification. The 30-day interval for testing that applies for the U.S. Salmonella Monitored Program under § 145.103(d) states: “An Authorized Agent shall collect a minimum of five environmental samples, e.g., chick papers, hatching trays, and chick transfer devices, from the hatchery at least every 30 days. Testing must be performed at an authorized laboratory.”

We proposed to establish a U.S. Newcastle Disease (ND) Clean program within the NPIP regulations.

One commenter asked what the testing methods for vaccinated and unvaccinated flocks would be for ND.

As we noted in the proposed rule, the approved serological tests for ND are currently the ELISA and hemagglutination inhibition (HI) tests, and the approved molecular-based test for ND is PCR.

The commenter also asked if lab costs were reimbursable for breeders who add ND tests to their regular surveillance protocol for backyard birds.

The new program generally does not apply to backyard poultry breeders, only primary breeders. Primary breeders should not expect an increase in lab costs; however, if lab costs occur, primary breeder labs will be expected to absorb the costs.

We proposed to allow voting delegates to represent multiple States.

A commenter inquired if there was a plan to ensure fair representation regarding delegation and the voting process.

In § 147.45 of the proposed rule, our proposed requirement was that “official delegates shall be elected by a representative group of participating industry members and be certified by the Official State Agency.” Further, “each official delegate shall endeavor to obtain, prior to the Conference, the recommendations of industry members of his State with respect to each proposed change.” We believe these provisions address the commenter's concern.

Comments Regarding Proposed Indemnity Revisions

One commenter expressed concerns about changes to part 56, our indemnity regulations for H5/H7 low pathogenic avian influenza (LPAI).

We proposed to amend the terms and definitions of H5/H7 LPAI infection (infected) and H5/H7 LPAI exposed. The new terms we proposed were H5/H7 LPAI virus exposed (non-infectious) and H5/H7 LPAI virus actively infected (infectious).

The commenter opined that this could lead to a dilution of an industry/Federal response to a LPAI event.

The revision to these terms does not change APHIS' response policies for LPAI events.

The regulations in part 56 had referred to payment for birds and eggs destroyed because of LPAI and payment for cleaning and disinfection activities as indemnity. In the proposed rule, we proposed to reserve the term indemnity to payment for birds and eggs destroyed because of LPAI, and to refer to payment for cleaning and disinfection activities as compensation. We also proposed definitions for compensation and indemnity. We indicated that this was necessary because the conditions for payment for the former, and the manner in which the amount paid is derived, differs significantly from the latter.

The commenter suggested that these revisions could adversely impact the payment of indemnity and compensation to producers.

We are redefining the terms indemnity and compensation for the purposes of clarifying the types of payments provided for response activities and make a distinction between indemnity, which is based on the fair market value of birds and eggs, and compensation, which is payment for response activities based on expenses incurred for those activities. These revisions to terminology do not pertain to the conditions for payment, nor how payment is calculated.

We proposed the use of a flat rate virus elimination (VE) calculator to determine compensation for VE activities for LPAI. The commenter also expressed concern that a flat rate VE calculator value would not fully compensate for VE activities necessary in all circumstances and all types of egg production facilities.

We explained that the VE calculator is intended to streamline payment for the majority of affected producers, but we recognize that the calculator may not be applicable for every production type and VE procedure. Therefore, as stated in the proposed rule, the claimant would be afforded the opportunity to demonstrate through receipts or other documentation the uniqueness of the situation and the actual cost of the activities, upon which the VE payment could be based.

The commenter recommended that VE payments be based on the value of the birds housed within a facility, rather than on the cost of eliminating virus from the structure.

We disagree. Compensation for VE activities is intended to cover the costs of those activities, which is not related to the value of the birds housed within a structure. However, we will consider the commenter's proposed methodology for determining the value of layers during our ongoing process of revising our methods of determining fair market value.

Miscellaneous

In reviewing the provisions of the proposed rule in preparation of this final rule, we noted several instances where the punctuation or the ordering of paragraphs could have led to differing interpretations of the regulations. For example, in several instances, conditions that were intended to be alternating (either one is sufficient) were punctuated in a manner which could make them appear to be joint conditions (both must be completed). In this final rule, we have changed punctuation and renumbered subparagraphs, as warranted, to improve clarity regarding our intent.

Similarly, there were several instances in the preamble of the proposed rule where we suggested wording would be revised each time it occurred within a particular regulatory unit, but neglected to propose to revise each occurrence in the proposed regulatory text for that unit. We have corrected these drafting errors in this final rule.

In this final rule, we are also making minor clarifying edits to paragraph (c) of § 56.4, which discusses the compliance agreements that parties must enter into in order to receive indemnity and/or compensation. We are clarifying that compliance agreements are similar to a statement of work, and may also be referred to as a detailed financial plan. This reflects APHIS guidance to stakeholders regarding the scope and intent of such compliance agreements.

In the proposed rule, we proposed that indemnity for the destruction and disposal of poultry would be calculated using an indemnity calculator, rather than an in-person appraisal of fair market value. Because APHIS is in the process of discontinuing the use of the calculator in favor of a different appraisal apparatus, we have elected not to finalize these proposed changes.

Finally, as noted above, our proposed rule had provisions that allowed for calculating payment for virus elimination using a method other than a VE calculator. However, it did not clarify under what circumstances APHIS would reach such a determination. In this final rule, we are clarifying that this will occur when the claimant and APHIS jointly agree the VE calculator is not applicable to the premises type.

Therefore, for the reasons given in the proposed rule, we are adopting the proposed rule as a final rule with the changes noted above.

Executive Orders 12866 and 13771 and Regulatory Flexibility Act

This final 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. Further, because this rule is not significant, it is not a regulatory action under Executive Order 13771.

We have prepared an analysis regarding the economic effects of this final rule on small entities. The analysis is summarized below. Copies of the full analysis are available on the Regulations.gov website (see footnote 1 in this document for a link to Regulations.gov) or by contacting the person listed under FOR FURTHER INFORMATION CONTACT.

We are amending the NPIP, its auxiliary provisions, and the indemnity regulations for the control of H5 and H7 low pathogenic avian influenza to align the regulations with international standards and make them more transparent to stakeholders and the general public. The changes in this final rule were voted on and approved by the voting delegates at the 2018 NPIP National Plan Conference.

The establishments that will be affected by the rule—principally entities engaged in poultry production and processing—are predominantly small by Small Business Administration standards. In those instances in which an addition to or modification of requirements could potentially result in a cost to certain entities, we do not expect the costs to be significant. NPIP membership is voluntary. The changes contained in this final rule were decided upon by the NPIP General Conference Committee and voting delegates during the 2018 NPIP Biennial Conference; the changes were recognized by the poultry industry as being in their interest.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service 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 final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are in conflict with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings 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 requirements included in this final rule were filed under Office of Management and Budget (OMB) control number 0579-0474. When OMB notifies us of its decision, if approval is denied, we will publish a document in the Federal Register providing notice of what action we plan to take.

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 rule, please contact Mr. Joseph Moxey, APHIS' Information Collection Coordinator, at [phone].

Congressional Review Act

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), the Office of Information and Regulatory Affairs has designated this action as a rule that is not a major rule, as defined by 5 U.S.C. 804(2).

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 are amending 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. Section 56.1 is amended as follows:

a. By adding, in alphabetical order, definitions for Cleaning, Compensation, and Disinfection;

b. By removing the definitions for H5/H7 LPAI exposed and H5/H7 LPAI virus infection (infected); and

c. By adding, in alphabetical order, definitions for H5/H7 LPAI virus actively infected (infectious), H5/H7 LPAI virus exposed (non-infectious), Indemnity, and Virus elimination (VE).

The additions read as follows:

§ 56.1

Definitions.

* * * * *

Cleaning. The removal of gross contamination, organic material, and debris from the premises or respective structures, via mechanical means like sweeping (dry cleaning) and/or the use of water and soap or detergent (wet cleaning), in order to minimize organic material to prepare for effective disinfection.

* * * * *

Compensation. In the case of H5/H7 LPAI detection, compensation specifically refers to reimbursement for the activities associated with the depopulation of infected or exposed poultry, including the disposal of contaminated carcasses and materials and the cleaning and disinfection of premises, conveyances, and materials that came into contact with infected or exposed poultry. In the case of contaminated materials, if the cost of cleaning and disinfection would exceed the value of the materials, or cleaning and disinfection would be impracticable for any reason, APHIS' Veterinary Services will base compensation on the fair market value (depreciated value) of those materials. Compensation does not include payment for depopulated birds or eggs destroyed (see definition of Indemnity in this section).

* * * * *

Disinfection. Methods used on surfaces to destroy or eliminate H5/H7 LPAI virus through physical (e.g., heat) or chemical (e.g., disinfectant) means. A combination of methods may be required.

* * * * *

H5/H7 LPAI virus actively infected (infectious). (1) Poultry will be considered to be actively infected with H5/H7 LPAI for the purposes of this part if:

(i) H5/H7 LPAI virus has been isolated and identified as such from poultry; or

(ii) Viral antigen or viral RNA specific to the H5 or H7 subtype of AI virus has been detected in poultry.

(2) The official determination that H5/H7 LPAI virus has been isolated and identified, or viral antigen or viral RNA specific to the H5 or H7 subtype of AI virus has been detected, may only be made by the National Veterinary Services Laboratories.

H5/H7 LPAI virus exposed (non-infectious). (1) Poultry will be considered to be exposed (non-infectious) to H5/H7 LPAI for the purposes of this part if:

(i) Antibodies to the H5 or H7 subtype of the AI virus that are not a consequence of vaccination have been detected in poultry; and

(ii) Samples collected from the flock using real-time reverse transcription polymerase chain reaction (RT-PCR) or virus isolation are determined to be not infectious for H5/H7 LPAI.

(2) The official determination that H5/H7 LPAI virus exposure has occurred is by the identification of antibodies to the H5 or H7 subtype of AI virus detected and may only be made by the National Veterinary Services Laboratories.

Indemnity. Payments representing the fair market value of destroyed birds and eggs. Indemnity does not include reimbursements for depopulation, disposal, destroyed materials, or cleaning and disinfection (virus elimination) activities; these activities are covered under compensation (see definition of Compensation in this section).

* * * * *

Virus elimination (VE). Cleaning and disinfection measures conducted to destroy or eliminate all AI virus on an affected premises.

3. Section 56.3 is amended by revising the section heading and paragraphs (a) introductory text, (b), and (c) to read as follows:

§ 56.3

Payment of indemnity and/or compensation.

(a) Activities eligible for indemnity and/or compensation. The Administrator may pay indemnity and/or compensation for the activities listed in this paragraph (a), as provided in paragraph (b) of this section:

* * * * *

(b) Percentage of costs eligible for indemnity and/or compensation. Except for poultry that are described by the categories in this paragraph (b), the Administrator is authorized to pay 100 percent of the costs and/or compensation, as determined in accordance with § 56.4, of the activities described in paragraphs (a)(1) through (3) of this section, regardless of whether the infected or exposed poultry participate in the Plan. For infected or exposed poultry that are described by the categories in this paragraph (b), the Administrator is authorized to pay 25 percent of the costs of the activities described in paragraphs (a)(1) through (3) of this section:

(1)(i) The poultry are from a breeding flock, commercial flock, or slaughter plant that participates in any Plan program in part 145 or 146 of this chapter but that does not participate in the U.S. Avian Influenza Clean, U.S. H5/H7 Avian Influenza Clean, or U.S. H5/H7 Avian Influenza Monitored program of the Plan available to the flock in part 145 or 146 of this chapter; and

(ii) The poultry are from:

(A) A commercial table-egg laying premises with at least 75,000 birds; or

(B) A meat-type chicken slaughter plant that slaughters at least 200,000 meat-type chickens in an operating week; or

(C) A meat-type turkey slaughter plant that slaughters at least 2 million meat-type turkeys in a 12-month period; or

(D) A commercial waterfowl and commercial upland game bird slaughter plant that slaughters at least 50,000 birds annually; or

(E) A raised-for-release upland game bird premises, raised-for-release waterfowl premises, and commercial upland game bird or commercial waterfowl producing eggs for human consumption premises that raise at least 25,000 birds annually; or

(F) A breeder flock premises with at least 5,000 birds.

(2) The poultry are located in a State that does not participate in the diagnostic surveillance program for H5/H7 LPAI, as described in § 146.14 of this chapter, or that does not have an initial State response and containment plan for H5/H7 LPAI that is approved by APHIS under § 56.10, unless such poultry participate in the Plan with another State that does participate in the diagnostic surveillance program for H5/H7 LPAI, as described in § 146.14 of this chapter, and has an initial State response and containment plan for H5/H7 LPAI that is approved by APHIS under § 56.10.

(c) Other sources of payment. If the recipient of indemnity and/or compensation for any of the activities listed in paragraphs (a)(1) through (3) of this section also receives payment for any of those activities from a State or from other sources, the indemnity and/or compensation provided under this part may be reduced by the total amount of payment received from the State or other sources to the extent that total payments do not exceed 100 percent of total reimbursable indemnity and/or compensation amounts.

4. Section 56.4 is revised to read as follows:

§ 56.4

Determination of indemnity and/or compensation amounts.

(a) Destruction and disposal of poultry. (1) Indemnity for the destruction of poultry and/or eggs infected with or exposed to H5/H7 LPAI will be based on the fair market value of the poultry and/or eggs, as determined by an appraisal. Poultry infected with or exposed to H5/H7 LPAI that are removed by APHIS or a Cooperating State Agency from a flock will be appraised by an APHIS official appraiser and a State official appraiser jointly, or, if APHIS and State authorities agree, by either an APHIS official appraiser or a State official appraiser alone. For laying hens, the appraised value should include the hen's projected future egg production. Appraisals of poultry must be reported on forms furnished by APHIS and signed by the appraisers and must be signed by the owners of the poultry to indicate agreement with the appraisal amount. Appraisals of poultry must be signed by the owners of the poultry prior to the destruction of the poultry, unless the owners, APHIS, and the Cooperating State Agency agree that the poultry may be destroyed immediately. Reports of appraisals must show the number of birds and the value per head.

(2) Compensation for disposal of poultry and/or eggs infected with or exposed to H5/H7 LPAI will be based on receipts or other documentation maintained by the claimant verifying expenditures for disposal activities authorized by this part. Any disposal of poultry infected with or exposed to H5/H7 LPAI for which compensation is requested must be performed under a compliance agreement between the claimant and APHIS. APHIS will review claims for compensation for disposal to ensure that all expenditures relate directly to activities described in § 56.5 and in the initial State response and containment plan described in § 56.10. If disposal is performed by the Cooperating State Agency, APHIS will compensate the Cooperating State Agency for disposal under a cooperative agreement.

(3) The destruction and disposal of the poultry and/or eggs must be conducted in accordance with the initial State response and containment plan for H5/H7 LPAI, as described in § 56.10.

(b) Cleaning and disinfection (virus elimination). (1) Compensation for cleaning and disinfection (virus elimination) of premises, conveyances, and materials that came into contact with poultry that are infected with or exposed to H5/H7 LPAI will be determined using the current APHIS flat-rate virus elimination (VE) calculator in effect at the time of the infection, except in instances when the claimant and APHIS jointly agree the VE calculator is not applicable to the premises type.

(2) For premises types for which a flat-rate VE calculator is not applicable, reimbursement will be based on receipts or other documentation maintained by the claimant verifying expenditures for cleaning and disinfection (virus elimination) activities authorized by this part. Any cleaning and disinfection (virus elimination) of premises, conveyances, and materials for which compensation is requested must be performed under a compliance agreement between the claimant, the Cooperating State Agency, and APHIS. APHIS will review claims for compensation for cleaning and disinfection (virus elimination) to ensure that all expenditures relate directly to activities described in § 56.5 and in the initial State response and containment plan described in § 56.10.

(i) In the case of materials, if the cost of cleaning and disinfection (virus elimination) would exceed the value of the materials or cleaning and disinfection (virus elimination) would be impracticable for any reason, compensation for the destruction of the materials will be based on the fair market value (depreciated value) of those materials, as determined by an appraisal. Materials will be appraised by an APHIS official appraiser. Compensation for disposal of the materials will be based on receipts or other documentation maintained by the claimant verifying expenditures for disposal activities authorized by this part. Appraisals of materials must be reported on forms furnished by APHIS and must be signed by the appraisers and by the owners of the materials to indicate agreement with the appraisal amount. Appraisals of materials must be signed and received by APHIS prior to the disassembly or destruction of the materials, unless the owners, APHIS, and the Cooperating State Agency agree in writing that the materials may be disassembled and/or destroyed immediately. Any disposal of materials for which compensation is requested must be performed under a compliance agreement between the claimant, the Cooperating State Agency, and APHIS. APHIS will review claims for compensation for disposal to ensure that all expenditures relate directly to activities described in § 56.5 and in the initial State response and containment plan described in § 56.10.

(ii) [Reserved]

(c) Requirements for compliance agreements. The compliance agreement is a comprehensive document that describes the depopulation, disposal, and cleaning and disinfection plans for poultry that were infected with or exposed to H5/H7 LPAI, or a premises that contained such poultry. The compliance agreement must set out cost estimates that include labor, materials, supplies, equipment, personal protective equipment, and any additional information deemed necessary by APHIS. A compliance agreement is comparable to a statement of work and must indicate what tasks will be completed, who will be responsible for each task, and how much the work is expected to cost. A compliance agreement may also be referred to as a detailed financial plan. Once work associated with the compliance agreement is completed, receipts and documentation detailing the activities specified in the agreement should be forwarded to APHIS for review, approval, and final payment. This documentation should be submitted to APHIS no later than 30 days after the quarantine release of the affected or exposed premises.

(Approved by the Office of Management and Budget under control numbers 0579-0007 and 0579-0474)

5. Section 56.5 is amended as follows:

a. By revising the section heading;

b. In paragraph (c)(1) introductory text, by adding the words “and maintain their current National Poultry Improvement Plan (NPIP) certifications” after the words “controlled marketing”; and

c. By revising paragraphs (c)(2) and (d).

The revisions read as follows:

§ 56.5

Destruction and disposal of poultry and cleaning and disinfection (virus elimination) of premises, conveyances, and materials.

* * * * *

(c) * * *

(2) Poultry moved for controlled marketing will not be eligible for indemnity under § 56.3. However, any costs related to cleaning and disinfection (virus elimination) of premises, conveyances, and materials that came into contact with poultry that are moved for controlled marketing will be eligible for compensation under § 56.3.

(d) Cleaning and disinfection (virus elimination) of premises, conveyances, and materials. Premises, conveyances, and materials that came into contact with poultry infected with or exposed to H5/H7 LPAI must be cleaned and disinfected; Provided, that materials for which the cost of cleaning and disinfection would exceed the value of the materials or for which cleaning and disinfection would be impracticable for any reason may be destroyed and disposed. Cleaning and disinfection must be performed in accordance with the initial State response and containment plan described in § 56.10, which must be approved by APHIS. Cleaning and disinfection must also be performed in accordance with any applicable State and local environmental regulations.

6. Section 56.6 is amended as follows:

a. By revising the section heading;

b. In paragraph (a), by removing the word “Compensation” and adding the word “Indemnity” in its place;

c. By revising paragraph (b); and

d. In paragraph (c), by adding the words “(virus elimination)” after the word “disinfection” each time it appears.

The revision reads as follows:

§ 56.6

Presentation of claims for indemnity and/or compensation.

* * * * *

(b) Indemnity for the value of eggs to be destroyed due to infection or exposure to H5/H7 LPAI; and

* * * * *

7. Section 56.8 is amended as follows:

a. In paragraph (a) introductory text, by removing the word “may” and adding the word “shall” in its place; and

b. By revising paragraph (b).

The revision reads as follows:

§ 56.8

Conditions for payment.

* * * * *

(b)(1) If indemnity for the destroyed poultry or eggs is being provided for 100 percent of eligible costs under § 56.3(b), the Administrator may pay contractors eligible for indemnity under this section 100 percent of the amount determined in paragraph (a) of this section.

(2) If indemnity for the destroyed poultry or eggs is being provided for 25 percent of eligible costs under § 56.3(b), the Administrator may pay contractors eligible for indemnity under this section 25 percent of the amount determined in paragraph (a) of this section.

* * * * *

§ 56.9

[Amended]

8. Section 56.9 is amended as follows:

a. In paragraph (a), by removing the citation “§ 56.4(a)(1)” and adding the citation “§ 56.4(a)” in its place; and

b. In paragraph (b), by adding the words “and/or compensation” after the word “indemnity” both times it appears.

9. Section 56.10 is amended as follows:

a. In paragraph (a) introductory text, by adding the words “and/or compensation” after the word “indemnity”; and

b. By adding an OMB citation at the end of the section.

The addition reads as follows:

§ 56.10

Initial State response and containment plan.

* * * * *

(Approved by the Office of Management and Budget under control number 0579-0474)

PART 145—NATIONAL POULTRY IMPROVEMENT PLAN FOR BREEDING POULTRY

10. 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.

11. Section 145.1 is amended as follows:

a. By revising the definition for Avian influenza;

b. By adding, in alphabetical order, a definition for Newcastle disease; and

c. By revising the definition for NPIP Program Standards.

The revisions and addition read as follows:

§ 145.1

Definitions.

* * * * *

Avian influenza. Avian influenza is defined as an infection of poultry caused by any influenza A virus of the H5 or H7 subtypes or by any influenza A virus with an intravenous pathogenicity index (IVPI) greater than 1.2 (or as an alternative at least 75 percent mortality).

* * * * *

Newcastle disease. Newcastle disease (ND) is defined as an infection of poultry caused by Newcastle disease virus (NDV), which is an avian paramyxovirus serotype 1 (APMV-1) that meets one of the following criteria for virulence:

(1) The virus has an intracerebral pathogenicity index (ICPI) in day-old chicks (Gallusgallus) of 0.7 or greater; or

(2) Multiple basic amino acids have been demonstrated in the virus (either directly or by deduction) at the C-terminus of the F2 protein and phenylalanine at residue 117, which is the N-terminus of the F1 protein. The term `multiple basic amino acids' refers to at least three arginine or lysine residues between residues 113 and 116. Failure to demonstrate the characteristic pattern of amino acid residues as described in the preceding sentences would require characterization of the isolated virus by an ICPI test.

NPIP Program Standards. A document that contains tests and sanitation procedures approved by the Administrator in accordance with § 147.53 of this subchapter for use under this subchapter. This document may be obtained from the National Poultry Improvement Plan (NPIP) website at http://www.poultryimprovement.org/​ or by writing to the Service at National Poultry Improvement Plan, APHIS, USDA, 1506 Klondike Road, Suite 101, Conyers, GA 30094.

* * * * *

12. Section 145.7 is revised to read as follows:

§ 145.7

Specific provisions for participating dealers.

Dealers in hatching eggs, newly hatched poultry, or started poultry shall comply with the provisions in this part (within the NPIP Program Standards document, Program Standard C applies to hatcheries; alternatives to the program standards may also be approved by the Administrator under § 147.53 of this subchapter).

13. Section 145.14 is amended as follows:

a. By revising paragraphs (d)(1) and (2) introductory text; and

b. By adding paragraph (e).

The revisions and addition read as follows:

§ 145.14

Testing.

* * * * *

(d) * * *

(1) Antibody detection tests—(i) Enzyme-linked immunosorbent assay (ELISA) test. (A) The ELISA test must be conducted using test kits approved by the Department and the Official State Agency and must be conducted in accordance with the recommendations of the producer or manufacturer.

(B) When positive ELISA samples are identified, an AGID test must be conducted within 48 hours.

(ii) Agar gel immunodiffusion (AGID) test. (A) The AGID test must be conducted using reagents approved by the Department and the Official State Agency.

(B) The AGID test for avian influenza must be conducted in accordance with this section (within the NPIP Program Standards document, Program Standard A applies to blood and yolk testing procedures; alternatives to the program standards may also be approved by the Administrator under § 147.53 of this subchapter) for the avian influenza agar gel immunodiffusion (AGID) test. The test can be conducted on egg yolk or blood samples. The AGID test is not recommended for use in waterfowl.

(C) Positive tests for the AGID must be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment may be based upon further sampling and appropriate tests for confirmation.

(2) Agent detection tests. Agent detection tests may be used to detect influenza A virus but not to determine hemagglutinin or neuraminidase subtypes. Samples for agent detection testing should be collected from naturally occurring flock mortality or clinically ill birds.

* * * * *

(e) For Newcastle Disease (ND). The official tests for ND are serological tests for antibody detection or molecular-based tests for antigen detection.

* * * * *

§ 145.23

[Amended]

14. Section 145.23 is amended as follows:

a. By removing paragraphs (d)(1)(vi) and (vii) and redesignating paragraphs (d)(1)(viii) and (ix) as paragraphs (d)(1)(vi) and (vii), respectively; and

b. By removing paragraph (d)(3) and redesignating paragraphs (d)(4) and (5) as paragraphs (d)(3) and (4), respectively.

§ 145.24

[Amended]

15. In § 145.24, paragraph (a)(1)(i) is amended by removing “§ 145.23(b)(3)(i) through (vii), § 145.33(b)(3)(i) through (vii), § 145.43(b)(3)(i) through (vi), § 145.53(b)(3)(i) through (vii), § 145.73(b)(2)(i), § 145.83(b)(2)(i), and § 145.93(b)(3)(i) through (vii)” and adding “§§ 145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) through (ix)” in its place.

16. Section 145.33 is amended as follows:

a. In paragraph (l)(1)(ii), by removing the number “30” and adding the number “15” in its place; and

b. By revising paragraph (l)(2).

The revision reads as follows:

§ 145.33

Terminology and classification; flocks and products.

* * * * *

(l) * * *

(2) 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.

* * * * *

§ 145.34

[Amended]

17. In § 145.34, paragraph (a)(1)(i) is amended by removing “§ 145.23(b)(3)(i) through (vii), § 145.33(b)(3)(i) through (vii), § 145.43(b)(3)(i) through (vi), § 145.53(b)(3)(i) through (vii), § 145.73(b)(2)(i), § 145.83(b)(2)(i), and § 145.93(b)(3)(i) through (vii)” and adding “§§ 145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) through (ix)” in its place.

18. Section 145.43 is amended by adding paragraph (h) and revising the OMB citation at the end of the section to read as follows:

§ 145.43

Terminology and classification; flocks and products.

* * * * *

(h) U.S. Newcastle Disease Clean. The program in this paragraph (h) is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of Newcastle disease. It is intended to determine the presence of Newcastle disease in primary breeding turkeys through vaccination and/or monitoring of each participating breeding flock. A flock and the hatching eggs and poults produced from it will qualify for classification in this paragraph (h) when the Official State Agency determines that they have met the following requirements:

(1) It is a primary breeding flock that is either:

(i) Vaccinated for Newcastle disease using USDA-licensed vaccines and response to vaccination is serologically monitored using an approved test as described in § 145.14 when more than 4 months of age, and meets the criteria in paragraph (h)(2) of this section to retain classification; or

(ii) Unvaccinated for Newcastle disease, in which a minimum of 30 birds have tested negative to ND using an approved test as described in § 145.14 when more than 4 months of age and meets criteria in paragraph (h)(3) of this section to retain classification.

(2) To retain the classification in this paragraph (h) for vaccinated flocks:

(i) Vaccines for ND must be USDA-licensed vaccines administered during early stages of development through rearing, and inactivated vaccines as final vaccination prior to the onset of egg production; and

(ii) The flock has been monitored for antibody response using approved serological tests as listed in § 145.14 and the results are compatible with immunological response against ND vaccination; and

(iii) Testing must include a minimum of 30 birds with a serologic monitoring program when more than 4 months of age and prior to the onset of production and not longer than every 90 days thereafter.

(3) To retain the classification in this paragraph (h) for unvaccinated flocks:

(i) A minimum of 30 birds per flock must test negative using an approved test in § 145.14 at intervals of 90 days; or

(ii) 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

(iii) During each 90-day period, all primary spent fowl, up to a maximum of 30, must test negative to ND within 21 days prior to movement to slaughter.

(4) Newcastle disease must be a disease reportable to the responsible State authority (State veterinarian, etc.) by all licensed veterinarians. To accomplish this, all laboratories (private, State, and university laboratories) that perform diagnostic procedures on poultry must examine all submitted cases of unexplained respiratory disease, egg production drops, and mortality for ND.

(Approved by the Office of Management and Budget under control numbers 0579-0007 and 0579-0474)

§ 145.44

[Amended]

19. In § 145.44, paragraph (a)(1)(i) is amended by removing “§ 145.23(b)(3)(i) through (vii), § 145.33(b)(3)(i) through (vii), § 145.43(b)(3)(i) through (vi), § 145.53(b)(3)(i) through (vii), § 145.73(b)(2)(i), § 145.83(b)(2)(i), and § 145.93(b)(3)(i) through (vii)” and adding “§§ 145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), § 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) through (ix)” in its place.

20. Section 145.45 is amended as follows:

a. By revising paragraph (a) introductory text;

b. In paragraph (a)(1) introductory text, by adding the words “and ND” after the word “AI” each time it appears;

c. In paragraph (a)(1)(i):

i. By adding the words “and ND Clean in accordance with § 145.43(h)” after the citation “§ 145.43(g)”;

ii. By adding the words “and ND” after the words “official tests for AI” and adding the words “and (e)” after the citation “§ 145.14(d)”; and

iii. By removing the word “AI-related” and adding the words “AI and ND-related” in its place;

d. In paragraphs (a)(1)(iii) introductory text, (a)(1)(iii)(B) and (E), and (a)(1)(v), by adding the words “and ND” after the word “AI” each time it appears;

e. In paragraph (a)(1)(vi), by adding the words “and ND” after the word “Influenza”;

f. In paragraph (a)(2)(iii):

i. By removing the words “Clean classification” and adding the words “and ND Clean classifications” in their place;

ii. By adding the words “and ND” after the word “AI” both times it appears; and

iii. By removing the words “avian influenza surveillance” and adding the words “avian influenza and ND surveillance” in their place;

g. In paragraph (a)(3)(iii), by adding the words “and ND” after the word “Influenza”;

h. In paragraph (a)(3)(iv), by adding the words “and ND Clean program as described in § 145.43(h)” after the citation “§ 145.43(g)”;

i. In paragraph (a)(3)(vii), by adding the words “and (h)” after the citation “145.43(g)”;

j. In paragraph (a)(4), by adding the words “and ND” after the word “AI” both times it appears; and

k. By adding an OMB citation at the end of the section.

The revision and addition read as follows:

§ 145.45

Terminology and classification; compartments.

(a) US H5/H7 AI and ND Clean Compartment. The program in this section is intended to be the basis from which the primary turkey breeding-hatchery industry may demonstrate the existence and implementation of a program that has been approved by the Official State Agency and APHIS to establish a compartment consisting of a primary breeding-hatchery company that is free of H5/H7 avian influenza (AI) and ND. This compartment has the purpose of protecting the defined subpopulation and avoiding the introduction and spread of H5/H7 AI and ND within that subpopulation by prohibiting contact with other commercial poultry operations, other domestic and wild birds, and other intensive animal operations. The program shall consist of the following:

* * * * *

(Approved by the Office of Management and Budget under control number 0579-0474)

21. The heading for subpart E, consisting of §§ 145.51 through 146.54, is revised to read as follows:

Subpart E—Special Provisions for Hobbyist and Exhibition Poultry, and Raised-for-Release Waterfowl Breeding Flocks and Products

22. Section 145.51 is amended as follows:

a. By removing the definition for Game birds;

b. By adding, in alphabetical order, definitions for Hobbyist poultry and Raised-for-release waterfowl; and

c. By removing the definition for Waterfowl.

The additions read as follows:

§ 145.51

Definitions.

* * * * *

Hobbyist poultry. Domesticated fowl which are bred for the purpose of meat and/or egg production on a small scale as determined by the Official State Agency.

Raised-for-release waterfowl. Domesticated fowl that normally swim, such as ducks and geese, grown under confinement for the primary purpose of producing eggs, chicks, started, or mature birds for release on game preserves or in the wild.

23. Section 145.52 is amended as follows:

a. By revising the introductory text;

b. In paragraph (c), by removing the words “in open-air facilities”; and

c. By adding paragraph (f).

The revision and addition read as follows:

§ 145.52

Participation.

Participating flocks of hobbyist and exhibition poultry, raised-for-release waterfowl, and the eggs, chicks, started, and mature poultry produced from them shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart. The special provisions that apply to meat-type waterfowl flocks are found in subpart I of this part. The special provisions that apply to game bird flocks are found in subpart J of this part.

* * * * *

(f) All participating raised-for-release waterfowl flocks, regardless of whether they are breeders or non-breeders, shall be enrolled under this subpart.

24. Section 145.53 is amended as follows:

a. In the introductory text, by removing the words “and baby” and adding the words “, chicks, started, and mature” in their place.

b. In paragraph (b)(5), by removing the words “exhibition waterfowl or”; and

c. By revising paragraph (f).

The revision reads as follows:

§ 145.53

Terminology and classification; flocks and products.

* * * * *

(f) U.S. Salmonella Monitored. The program in this paragraph (f) is intended to be the basis from which the breeding-hatching industry may conduct a program for the prevention and control of salmonellosis. It is intended to reduce the incidence of Salmonella organisms in hatching eggs and day-old poultry through an effective and practical sanitation and testing program at the breeder farm and in the hatchery. This will afford other segments of the poultry industry an opportunity to reduce the incidence of Salmonella in their products. The following requirements must be met for a flock or hatchery to be eligible for the classification in this paragraph (f) as determined by the Official State Agency:

(1) Hatcheries must be kept in a sanitary condition as applicable and as outlined in § 145.6 (within the NPIP Program Standards document, Program Standard C applies to hatcheries; alternatives to the program standards may also be approved by the Administrator under § 147.53 of this subchapter).

(2) An Authorized Agent shall collect and submit to an authorized laboratory:

(i) A minimum of five samples from the hatchery at least every 30 days while in operation. These samples may include: Hatchery debris, swabs from hatchers, setters, hatchery environment, hatchery equipment, sexing tables and belts, meconium, chick box papers, hatching trays, or chick transfer devices. Samples will be examined bacteriologically at an authorized laboratory for Salmonella; and

(ii) Annual environmental samples from each pullet and breeder farm in accordance with this section (within the NPIP Program Standards document, Program Standard B applies to bacteriological examination procedures; alternatives to the program standards may also be approved by the Administrator under § 147.53 of this subchapter). Samples will be examined bacteriologically at an authorized laboratory for Salmonella.

(3) If Salmonella is identified through this testing:

(i) A qualified poultry health professional knowledgeable with the operation will be consulted and will:

(A) Review test results to evaluate the Salmonella monitoring program.

(B) Use the Salmonella monitoring program test results to develop appropriate and practical Salmonella intervention measures.

(ii) [Reserved]

(4) To claim products are of the classification in this paragraph (f), all products shall be derived from a farm or hatchery that meets the requirements of the classification.

* * * * *

§ 145.54

[Amended]

25. In § 145.54, paragraph (a)(1)(i) is amended by removing “§ 145.23(b)(3)(i) through (vii), § 145.33(b)(3)(i) through (vii), § 145.43(b)(3)(i) through (vi), § 145.53(b)(3)(i) through (vii), § 145.73(b)(2)(i), § 145.83(b)(2)(i), and § 145.93(b)(3)(i) through (vii)” and adding “§§ 145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) through (ix)” in its place.

26. Section 145.73 is amended as follows:

a. By removing paragraphs (d)(1)(vi) and (vii) and redesignating paragraphs (d)(1)(viii) and (ix) as paragraphs (d)(1)(vi) and (vii), respectively;

b. By removing paragraph (d)(3) and redesignating paragraphs (d)(4) and (5) as paragraphs (d)(3) and (4), respectively; and

c. By adding paragraph (h) and an OMB citation at the end of the section.

The additions read as follows:

§ 145.73

Terminology and classification; flocks and products.

* * * * *

(h) U.S. Newcastle Disease Clean. The program in this paragraph (h) is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of Newcastle disease. It is intended to determine the presence of Newcastle disease in primary breeding chickens through vaccination and/or monitoring of each participating breeding flock. A flock and the hatching eggs and chicks produced from it will qualify for the classification in this paragraph (h) when the Official State Agency determines that they have met the following requirements:

(1) It is a primary breeding flock that is either:

(i) Vaccinated for Newcastle disease using USDA-licensed vaccines and response to vaccination is serologically monitored using an approved test as described in § 145.14 when more than 4 months of age and meets the criteria in paragraph (h)(2) of this section to retain classification; or

(ii) Unvaccinated for Newcastle disease, in which a minimum of 30 birds have tested negative to ND using an approved test as described in § 145.14 when more than 4 months of age and meets criteria in paragraph (h)(3) of this section to retain classification.

(2) To retain the classification in this paragraph (h) for vaccinated flocks:

(i) Vaccines for ND must be USDA-licensed vaccines administered during early stages of development through rearing, and inactivated vaccines as final vaccination prior to the onset of egg production; and

(ii) The flock has been monitored for antibody response using approved serological tests as listed in § 145.14 and the results are compatible with immunological response against ND vaccination; and

(iii) Testing must include a minimum of 30 birds with a serologic monitoring program when more than 4 months of age and prior to the onset of production and not longer than every 90 days thereafter.

(3) To retain the classification in this paragraph (h) for unvaccinated flocks:

(i) A minimum of 30 birds per flock must test negative using an approved test as described in § 145.14 at intervals of 90 days; or

(ii) 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

(iii) During each 90-day period, all primary spent fowl, up to a maximum of 30, must test negative to ND within 21 days prior to movement to slaughter.

(4) Newcastle disease must be a disease reportable to the responsible State authority (State veterinarian, etc.) by all licensed veterinarians. To accomplish this, all laboratories (private, State, and university laboratories) that perform diagnostic procedures on poultry must examine all submitted cases of unexplained respiratory disease, egg production drops, and mortality for ND.

(Approved by the Office of Management and Budget under control number 0579-0474)

27. Section 145.74 is amended as follows:

a. In paragraph (a) introductory text, by revising the heading, adding the words “and Newcastle disease (ND)” after the word “(AI)”, and adding the words “and ND” after the word “AI”;

b. In paragraph (a)(1) introductory text, by adding the words “and ND” after the word “AI” each time it appears;

c. In paragraph (a)(1)(i):

i. By adding the words “and ND Clean in accordance with § 145.73(h)” after the words “in accordance with § 145.73(f)”;

ii. By adding the words “and ND” after the words “official tests for AI” and adding the words “and (e)” after the citation “§ 145.14(d)”; and

iii. By removing the word “AI-related” and adding the words “AI and ND-related” in its place;

d. In paragraphs (a)(1)(iii) introductory text, (a)(1)(iii)(B) and (E), and (a)(1)(v), by adding the words “and ND” after the word “AI” each time it appears;

e. In paragraph (a)(1)(vi), by adding the words “and ND” after the word “Influenza”;

f. In paragraph (a)(2)(iii):

i. By removing the words “Clean classification” and adding the words “and ND Clean classifications” in their place;

ii. By adding the words “and ND” after the word “AI” both times it appears; and

iii. By removing the words “avian influenza surveillance” and adding the words “avian influenza and ND surveillance” in their place;

g. In paragraph (a)(3)(iii), by adding the words “and ND” after the word “Influenza”;

h. In paragraph (a)(3)(iv), by adding the words “and ND Clean program as described in

§ 145.73

(h)” after the citation “§ 145.73(f)”;

i. In paragraph (a)(3)(vii), by removing the citation “§§ 145.15 and 145.73(f)” and adding the citation “§§ 145.15, 145.73(f), and 145.73(h)” in its place;

j. In paragraph (a)(4), by adding the words “and/or ND” after the word “AI” both times it appears; and

k. By adding an OMB citation at the end of the section.

The revision and addition read as follows:

§ 145.74

Terminology and classification; compartments.

(a) U.S. Avian Influenza and Newcastle Disease Clean Compartment. * * *

* * * * *

(Approved by the Office of Management and Budget under control number 0579-0474)

28. Section 145.83 is amended as follows:

a. By removing paragraph (e)(1)(iv) and redesignating paragraphs (e)(1)(v) and (vi) as paragraphs (e)(1)(iv) and (v), respectively; and

b. By adding paragraph (h) and an OMB citation at the end of the section.

The additions read as follows:

§ 145.83

Terminology and classification; flocks and products.

* * * * *

(h) U.S. Newcastle Disease (ND) Clean. The program in this paragraph (h) is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of Newcastle disease. It is intended to determine the presence of Newcastle disease in primary breeding chickens through vaccination and/or monitoring of each participating breeding flock. A flock and the hatching eggs and chicks produced from it will qualify for the classification in this paragraph (h) when the Official State Agency determines that they have met the following requirements:

(1) It is a primary breeding flock that is either:

(i) Vaccinated for Newcastle disease using USDA-licensed vaccines and response to vaccination is serologically monitored using an approved test as described in § 145.14 when more than 4 months of age and meets the criteria in paragraph (h)(2) of this section to retain classification; or

(ii) Unvaccinated for Newcastle disease, in which a minimum of 30 birds have tested negative to ND using an approved test as described in § 145.14 when more than 4 months of age and meets criteria in paragraph (h)(3) of this section to retain classification.

(2) To retain the classification in this paragraph (h) for vaccinated flocks:

(i) Vaccines for ND must be USDA-licensed vaccines administered during early stages of development through rearing, and inactivated vaccines as final vaccination prior to the onset of egg production; and

(ii) The flock has been monitored for antibody response using approved serological tests as described in § 145.14 and the results are compatible with immunological response against ND vaccination; and

(iii) Testing must include a minimum of 30 birds with a serologic monitoring program when more than 4 months of age and prior to the onset of production, and not longer than every 90 days thereafter.

(3) To retain the classification in this paragraph (h) for unvaccinated flocks:

(i) A minimum of 30 birds per flock must test negative using an approved test as described in § 145.14 at intervals of 90 days; or

(ii) 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

(iii) During each 90-day period, all primary spent fowl, up to a maximum of 30, must test negative to ND within 21 days prior to movement to slaughter.

(4) Newcastle disease must be a disease reportable to the responsible State authority (State veterinarian, etc.) by all licensed veterinarians. To accomplish this, all laboratories (private, State, and university laboratories) that perform diagnostic procedures on poultry must examine all submitted cases of unexplained respiratory disease, egg production drops, and mortality for ND.

(Approved by the Office of Management and Budget under control number 0579-0474)

29. Section 145.84 is amended as follows:

a. In paragraph (a) introductory text, by revising the heading, adding the words “and Newcastle disease (ND)” after the words “influenza (AI)”, and adding the words “and ND” after the words “H5/H7 AI”;

b. In paragraph (a)(1) introductory text, by adding the words “and ND” after the word “AI” each time it appears;

c. By revising paragraph (a)(1)(i);

d. In paragraphs (a)(1)(iii) introductory text, (a)(1)(iii)(B) and (E), and (a)(1)(v), by adding the words “and ND” after the word “AI” each time it appears;

e. In paragraph (a)(1)(vi), by adding the words “and ND” after the word “Influenza”;

f. In paragraph (a)(2)(iii):

i. Removing the words “Clean classification” and adding the words “and ND Clean classifications” in their place;

ii. Adding the words “and ND” after the word “AI” both times it appears; and

iii. Removing the words “avian influenza surveillance” and adding the words “avian influenza and ND surveillance” in their place;

g. In paragraph (a)(3)(iv), by adding the words “and ND Clean program as described in § 145.83(h)” after the citation “§ 145.83(g)”;

h. In paragraph (a)(3)(vii), by adding the words “and (h)” after the citation “145.83(g)”;. and

i. By adding an OMB citation at the end of the section.

The revisions and addition read as follows:

§ 145.84

Terminology and classification; compartments.

(a) U.S. Avian Influenza and Newcastle Disease Clean Compartment. * * *

(1) * * *

(i) Definition and description of the subpopulation of birds and their health status. All birds included in the compartment must be U.S. Avian Influenza Clean in accordance with § 145.83(g) and ND Clean in accordance with § 145.83(h). The poultry must also be located in a State that has an initial State response and containment plan approved by APHIS under § 56.10 of this chapter and that participates in the diagnostic surveillance program for H5/H7 low pathogenicity AI as described in § 145.15. Within the compartment, all official tests for AI and ND, as described in § 145.14(d) and (e), must be conducted in State or Federal laboratories or in NPIP authorized laboratories that meet the minimum standards described in § 147.52 of this subchapter. In addition, the company must provide to the Service upon request any relevant historical and current H5/H7 AI and ND-related data for reference regarding surveillance for the disease and the health status of the compartment. Upon request, the Official State Agency may provide such data for other commercial poultry populations located in the State.

* * * * *

(Approved by the Office of Management and Budget under control number 0579-0474)

§ 145.94

[Amended]

30. In § 145.94, paragraph (a)(1)(i) is amended by removing the word “and” and adding “, and 145.103(b)(3)(i) through (ix)” after the citation “145.93(b)(3)(i) through (vii)”.

31. Subpart J, consisting of §§ 145.101 to 145.104, is added to read as follows:

Subpart J—Special Provisions for Egg/Meat-Type Game Bird and Raised-for-Release Game Bird Breeding Flocks and Products

145.101

Definitions.

145.102

Participation.

145.103

Terminology and classification; flocks and products.

145.104

Terminology and classification; States.

Subpart J—Special Provisions for Egg/Meat-Type Game Bird and Raised-for-Release Game Bird Breeding Flocks and Products

§ 145.101

Definitions.

Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean:

Egg/meat-type bird. Birds grown under confinement for the primary purpose of producing eggs and/or meat for human consumption.

Game birds. Domesticated fowl such as pheasants, partridge, quail, grouse, and guineas, but not doves and pigeons.

Raised-for-release bird. Birds grown under confinement for the primary purpose of producing eggs, chicks, started, or mature birds for release on game preserves or in the wild.

§ 145.102

Participation.

Participating flocks of egg/meat-type game birds, raised-for-release game birds, and the products produced from them shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart. Participation is broken into the following categories of operation and products:

(a) The categories for operation are:

(1) Breeder. An individual or business that maintains a breeding flock for the purpose of producing eggs, chicks, started, or mature birds. A breeder that is also a hatchery and/or grower shall be categorized as a breeder.

(2) Hatchery. A category of operations in which an individual or business does not have a breeding flock, but hatches eggs for the purpose of producing chicks, started, or mature birds. A hatchery that is also a grower shall be categorized as a hatchery.

(3) Grower. A category of operations in which an individual or business does not have a breeding flock or hatchery, but raises birds for the purpose of selling started or mature birds.

(4) Dealer. An individual or business that resells eggs, chicks, started, or mature birds. Products a dealer handles are typically resold within 30 days or less.

(b) The categories for products are:

(1) Egg. An egg laid by a female bird for the purpose of hatching a chick.

(2) Chick. A bird that is newly hatched from an egg.

(3) Started bird. A bird that is between the age of a newly hatched chick and a mature bird.

(4) Mature bird. A bird that is fully colored and has reached the average maximum size specific to each species.

(c) Products shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a).

(d) Hatching eggs produced by breeding flocks shall be nest clean, fumigated, or otherwise sanitized in accordance with part 147 of this subchapter.

(e) It is recommended that gallinaceous flocks and waterfowl flocks be kept separate.

(f) Any nutritive material provided to baby poultry must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10.

(g) A flock of game birds that are not breeders, but are located on the same premise as game bird breeders, shall be covered under the same NPIP hatchery approval number as long as the appropriate testing requirements have been met.

(h) All participating raised-for-release game bird flocks, regardless of whether they are breeders or non-breeders, shall be enrolled under this subpart.

(i) A breeder, hatchery, or grower may also be a dealer without being categorized as a dealer. To resell products under the assigned NPIP number and avoid losing NPIP flock classifications, products must be purchased from an NPIP participant with equal or greater classifications or from a flock with equivalent or greater testing requirements under official supervision.

(j) Subject to the approval of the Service and the Official State Agencies in the importing and exporting States, participating flocks may report poultry sales to importing States by using either VS Form 9-3, “Report of Sales of Hatching Eggs, Chicks, and Poults,” or by using an invoice form (9-3I) approved by the Official State Agency and the Service to identify poultry sales to clients. If the 9-3I form is used, the following information must be included on the form:

(1) The form number “9-3I”, printed or stamped on the invoice;

(2) The seller name and address;

(3) The date of shipment;

(4) The invoice number;

(5) The purchaser name and address;

(6) The quantity of products sold;

(7) Identification of the products by bird variety or by NPIP stock code as listed in the NPIP APHIS 91-55-078 appendix; and

(8) The appropriate NPIP illustrative design in § 145.10. One of the designs in § 145.10(b) or (g) must be used. The following information must be provided in or near the NPIP design:

(i) The NPIP State number and NPIP approval number; and

(ii) The NPIP classification for which product is qualified (e.g., U.S. Pullorum-Typhoid Clean).

§ 145.103

Terminology and classification; flocks and products.

Participating flocks, and the eggs, chicks, started, and mature birds produced from them, which have met the respective requirements specified in this section may be designated by the following terms and the corresponding designs illustrated in § 145.10.

(a) [Reserved]

(b) U.S. Pullorum-Typhoid Clean. A flock in which freedom from pullorum and typhoid has been demonstrated to the Official State Agency under paragraph (b)(1), (2), or (3) of this section. (See § 145.14 relating to the official blood test where applicable.):

(1) It has been officially blood tested within the past 12 months with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate S. pullorum or S. gallinarum.

(2) It is a started or mature bird flock that meets the following specifications as determined by the Official State Agency and the Service:

(i) The flock is located in a State where all persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated;

(ii) The flock is composed entirely of birds that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision; and

(iii) The flock is located on a premises where a flock not classified as U.S. Pullorum-Typhoid Clean was located the previous year; Provided, That an Authorized Testing Agent must blood test up to 300 birds per flock, as described in § 145.14, if the Official State Agency determines that the flock has been exposed to pullorum-typhoid. In making determinations of exposure and setting the number of birds to be blood tested, the Official State Agency shall evaluate the results of any blood tests, described in § 145.14(a)(1), that were performed on an unclassified flock located on the premises during the previous year; the origins of the unclassified flock; and the probability of contacts between the flock for which qualification is being sought and infected wild birds, contact between the flock for which qualification is being sought and contaminated feed or waste, or contact between the flock for which qualification is being sought and birds, equipment, supplies, or personnel from flocks infected with pullorum-typhoid.

(3) It is a breeding flock that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision, and in which a sample of 300 birds from flocks of more than 300, and each bird in flocks of 300 or less, has been officially tested for pullorum-typhoid with no reactors or reactors that upon bacteriologic examination fail to reveal Pullorum-Typhid: Provided, That a bacteriological examination monitoring program or serological examination monitoring program for game birds acceptable to the Official State Agency and approved by the Service may be used in lieu of annual blood testing: And provided further, That it is located in a State in which it has been determined by the Service that:

(i) All hatcheries within the State are qualified as “National Plan Hatcheries” or have met equivalent requirements for pullorum-typhoid control under official supervision;

(ii) All hatchery supply flocks within the State are qualified as U.S. Pullorum-Typhoid Clean or have met equivalent requirements for pullorum-typhoid control under official supervision: Provided, That if other domesticated fowl, except waterfowl, are maintained on the same premises as the participating flock, freedom from pullorum-typhoid infection shall be demonstrated by an official blood test of each of these fowl;

(iii) All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohibited;

(iv) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated;

(v) All reports of any disease outbreak involving a disease covered under the Plan are promptly followed by an investigation by the Official State Agency to determine the origin of the infection; Provided, That if the origin of the infection involves another State, or if there is exposure to poultry in another State from the infected flock, then the National Poultry Improvement Plan will conduct an investigation;

(vi) All flocks found to be infected with pullorum or typhoid are quarantined until marketed or destroyed under the supervision of the Official State Agency, or until subsequently blood tested, following the procedure for reacting flocks as contained in § 145.14(a)(5), and all birds fail to demonstrate pullorum or typhoid infection;

(vii) All poultry, including exhibition, exotic, and game birds, but excluding waterfowl, going to public exhibition shall come from U.S. Pullorum-Typhoid Clean or equivalent flocks, or have had a negative pullorum-typhoid test within 90 days of going to public exhibition; and

(viii) The flock is located in a State in which pullorum disease or fowl typhoid is not known to exist nor to have existed in hatchery supply flocks within the State during the preceding 24 months.

(ix) Discontinuation of any of the conditions or procedures described in paragraphs (b)(3)(i) through (viii) of this section, or the occurrence of repeated outbreaks of pullorum or typhoid in poultry breeding flocks within or originating within the State shall be grounds for the Service to revoke its determination that such conditions and procedures have been met or complied with. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity to present its views.

(c) U.S. H5/H7 Avian Influenza Clean. The program in this paragraph (c) is intended to be the basis from which the game bird industry may conduct a program for the prevention and control of the H5 and H7 subtypes of avian influenza. It is intended to determine the presence of the H5 and H7 subtypes of avian influenza in game bird flocks through routine surveillance of each participating flock. A flock or premises, and the hatching eggs, chicks, started, and mature birds produced from it, will qualify for the classification in this paragraph (c) when the Official State Agency determines that it has met the following requirements:

(1) It is a flock in which a minimum of 30 birds has been tested negative to the H5 and H7 subtypes of avian influenza as provided in § 145.14(d) when more than 4 months of age. To retain the classification in this paragraph (c):

(i) A sample of at least 30 birds must be tested negative at intervals of 90 days; or

(ii) A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds are tested within each 90-day period.

(2) For participants with non-breeding flocks retained for raised-for-release or other purposes on the same premises as a breeding flock, a representative sample of at least 30 birds from the participating premises must be tested negative to the H5 and H7 subtypes of avian influenza as provided in § 145.14(d) when more than 4 months of age, every 90 days.

(d) U.S. Salmonella Monitored. The program in this paragraph (d) is intended to be the basis from which the game bird industry may conduct a program for the prevention and control of salmonellosis. It is intended to reduce the incidence of Salmonella organisms in day-old poultry through an effective and practical sanitation program in the hatchery. This will afford other segments of the poultry industry an opportunity to reduce the incidence of Salmonella in their products. The following requirements must be met for a flock to be of this classification in this paragraph (d):

(1) An Authorized Agent shall collect a minimum of five environmental samples, e.g., chick papers, hatching trays, and chick transfer devices, from the hatchery at least every 30 days. Testing must be performed at an authorized laboratory.

(2) To claim products are of the classification in this paragraph (d), all products shall be derived from a hatchery that meets the requirements of the classification.

(3) The classification in this paragraph (d) may be revoked by the Official State Agency if the participant fails to follow recommended corrective measures.

§ 145.104

Terminology and classification; States.

(a) U.S. Pullorum-Typhoid Clean State. (1) A State will be declared a U.S. Pullorum-Typhoid Clean State when it has been determined by the Service that:

(i) The State is in compliance with the provisions contained in §§ 145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) through (ix).

(ii) No pullorum disease or fowl typhoid is known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months: Provided, That pullorum disease or fowl typhoid found within the preceding 24 months in waterfowl, exhibition poultry, and game bird breeding flocks will not prevent a State, which is otherwise eligible, from qualifying.

(2) If there is discontinuation of any of the conditions described in paragraph (a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatchery supply flocks described in paragraph (a)(1)(ii) of this section, or if an infection spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classification in this paragraph (a). Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity for a hearing in accordance with rules of practice adopted by the Administrator.

(b) [Reserved]

PART 146—NATIONAL POULTRY IMPROVEMENT PLAN FOR COMMERCIAL POULTRY

32. 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.

33. Section 146.13 is amended as follows:

a. By revising paragraph (b)(1); and

b. In paragraph (b)(2) introductory text, by removing the words “matrix gene or protein” and adding the word “virus” in their place.

The revision reads as follows:

§ 146.13

Testing.

* * * * *

(b) * * *

(1) Antibody detection tests—(i) Enzyme-linked immunosorbent assay (ELISA) test. (A) The ELISA test must be conducted using test kits approved by the Department and the Official State Agency and must be conducted in accordance with the recommendations of the producer or manufacturer.

(B) When positive ELISA samples are identified, an AGID test must be conducted within 48 hours.

(ii) Agar gel immunodiffusion (AGID) test. (A) The AGID test must be conducted using reagents approved by the Department and the Official State Agency.

(B) The AGID test for avian influenza must be conducted in accordance with this section (within the NPIP Program Standards, Program Standard A applies to blood and yolk testing procedures; alternatives to the program standards may also be approved by the Administrator under § 147.53 of this subchapter) for the avian influenza AGID test. The test can be conducted on egg yolk or blood samples. The AGID test is not recommended for use in waterfowl.

(C) Positive tests for the AGID must be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment may be based upon further sampling and appropriate tests for confirmation.

* * * * *

34. Section 146.51 is revised to read as follows:

§ 146.51

Definitions.

Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean:

Egg/meat-type game birds. Domesticated fowl such as pheasants, partridge, quail, grouse, and guineas, but not doves and pigeons grown under confinement for the primary purposes of producing eggs and/or meat for human consumption.

Egg/meat-type waterfowl. Domesticated ducks or geese grown under confinement for the primary purposes of producing eggs and/or meat for human consumption.

Meat-type game bird slaughter plant. A meat-type game bird slaughter plant 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.

Meat-type waterfowl slaughter plant. A meat-type waterfowl slaughter plant 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.

Shift. The working period of a group of employees who are on duty at the same time.

35. Section 146.52 is revised to read as follows:

§ 146.52

Participation.

(a) Participating meat-type game bird slaughter plants, meat-type waterfowl slaughter plants, and egg-type game bird and egg-type waterfowl premises producing eggs for human consumption shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart.

(b) Meat-type game bird slaughter plants and meat-type waterfowl slaughter plants that slaughter fewer than 50,000 birds annually are exempt from the special provisions of this subpart.

(c) Egg-type game bird and egg-type waterfowl premises with fewer than 25,000 birds are exempt from the special provisions of this subpart.

36. Section 146.53 is amended as follows:

a. In the introductory text, by adding the words “slaughter plants and” after the word “Participating” and removing the words “of this part”;

b. By revising paragraph (a) introductory text;

c. In paragraph (a)(1), by removing the words “commercial upland” and adding the word “meat-type” in their place and removing the word “commercial” and adding the word “meat-type” in its place;

d. By revising paragraph (a)(2);

e. In paragraph (a)(3), by removing the words “commercial upland” and adding the word “meat-type” in their place and removing the word “commercial” and adding the word “meat-type” in its place;

f. In paragraph (a)(4), by removing the words “a commercial upland” and adding the words “an egg-type” in their place and adding the word “egg-type” after the words “game bird or”.

g. In paragraph (a)(5), by removing the words “a commercial upland” and adding the words “an egg-type” in their place and adding the word “egg-type” after the words “game bird or”.

h. By removing and reserving paragraph (b).

The revisions read as follows:

§ 146.53

Terminology and classification; slaughter plants and premises.

* * * * *

(a) U.S. H5/H7 Avian Influenza Monitored. The program in this paragraph (a) is intended to be the basis from which the egg/meat-type game bird and egg/meat-type waterfowl industry may conduct a program to monitor for the H5/H7 subtypes of avian influenza. It is intended to determine the presence of the H5/H7 subtypes of avian influenza in egg/meat-type game birds and egg/meat-type waterfowl through routine surveillance of each participating slaughter plant or, in the case of egg-producing flocks, the regular surveillance of these flocks. A slaughter plant or flock will qualify for the classification in this paragraph (a) when the Official State Agency determines that it has met one of the following requirements:

* * * * *

(2) It is a meat-type game bird slaughter plant or meat-type waterfowl slaughter plant that only accepts egg/meat-type game birds or egg/meat-type waterfowl from flocks where a minimum of 11 birds per flock have been tested negative for the H5/H7 subtypes of avian influenza, as provided in § 146.13(b), no more than 21 days prior to slaughter;

* * * * *

PART 147—AUXILIARY PROVISIONS ON NATIONAL POULTRY IMPROVEMENT PLAN

37. 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.

38. Section 147.45 is revised to read as follows:

§ 147.45

Official delegates.

Each cooperating State shall be entitled to one official delegate for each of the programs prescribed in parts 145 and 146 of this subchapter in which it has one or more participants at the time of the Conference. 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. Individuals may be allowed to be an official delegate or alternate delegate for up to three States in which that delegate has flocks or is a plan participant with acknowledgement and approval of the Official State Agencies. Each official delegate shall endeavor to obtain, prior to the Conference, the recommendations of industry members of their State with respect to each proposed change.

39. Section 147.48 is revised to read as follows:

§ 147.48

Approval of conference recommendations by the Department.

Proposals adopted by the official delegates will be recommended to the Department for incorporation into the provisions of the National Poultry Improvement Plan (NPIP) in parts 56, 145, and 146 of this chapter and this subpart. The Department reserves the right to approve or disapprove the recommendations of the conference as an integral part of its sponsorship of the National Poultry Improvement Plan. The Department will publish the recommendations in the Federal Register within 14 months following the NPIP Biennial Conference.

40. In § 147.52, paragraph (b) is revised to read as follows:

§ 147.52

Authorized laboratories.

* * * * *

(b) Trained technicians. Testing procedures at all authorized laboratories must be run or overseen by a laboratory technician who every 4 years has attended, and satisfactorily completed, Service-approved laboratory workshops for Plan-specific diseases.

* * * * *

Done in Washington, DC, this 25th day of September 2020.

Mark Davidson,

Acting Administrator, Animal and Plant Health Inspection Service.

Footnotes

1.  To view the proposed rule, supporting documents, and the comments we received, go to http://www.regulations.gov/​#!docketDetail;​D=​APHIS-2018-0062.