Source: https://www.federalregister.gov/documents/2016/08/12/2016-19245/national-poultry-improvement-plan-and-auxiliary-provisions
Timestamp: 2019-02-21 04:19:05
Document Index: 432751723

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A Rule by the Animal and Plant Health Inspection Service on 08/12/2016
53247-53252 (6 pages)
0579-AE16
APHIS-2014-0101
Amendments to the NPIP Regulations, Their Auxiliary Provisions, and to Regulations Governing Avian Influenza Indemnity
https://www.federalregister.gov/d/2016-19245 https://www.federalregister.gov/d/2016-19245
We are amending the National Poultry Improvement Plan (NPIP), its auxiliary provisions, and the indemnity regulations for the control of H5 and H7 low pathogenic avian influenza. Specifically, we are clarifying who may participate in the NPIP, amending participation requirements, amending definitions for poultry and breeding stock, amending the approval process for new diagnostic tests, and amending slaughter plant inspection and laboratory inspection and testing requirements. These changes will align the regulations with international standards and make them more transparent to Animal and Plant Health Inspection Service stakeholders and the general public. The changes in this final rule were voted on and approved by the voting delegates at the Plan's 2014 National Plan Conference.
The regulations in 9 CFR parts 145, 146, and 147 (referred to below as the regulations) contain the provisions of the Plan. The Animal and Plant Health Inspection Service (APHIS, also referred to as “the Service”) of the U.S. Department of Agriculture (also referred to as “the Department”) amends these provisions from time to time to incorporate new scientific information and technologies within the Plan. In addition, the regulations in 9 CFR part 56 set out conditions for the payment of indemnity for costs associated with poultry that are infected with or exposed to H5/H7 low pathogenic avian influenza and provisions for a cooperative control program for the disease.
On March 24, 2016, we published in the Federal Register (81 FR 15652-15660, Docket No. APHIS-2014-0101) a proposal [1] to amend the regulations by clarifying who may participate in the NPIP and amending participation requirements. In addition, we proposed to amend definitions of poultry and breeding stock, amend the approval process for new diagnostic tests, and amend slaughter plant inspection and laboratory inspection and testing requirements.
We solicited comments concerning our proposal for 60 days ending May 23, 2016. We received one comment by that date. It was from an individual. The issues raised by the commenter are discussed below.
In the March 2016 proposed rule, we proposed to amend the definition of breeding flock in § 56.1 to remove the word “chicks” and replace it with the word “progeny.” The commenter objected to this change, suggesting that many people would not know the meaning of the latter term and would find it confusing.
We are not making any changes to the final rule in response to this comment. As stated in the March 2016 proposed rule, the term “progeny” is more accurate than “chicks” in this context because it is more inclusive of both chicken and turkey flocks. Young turkeys are known as poults rather than chicks. In addition, as we noted in the proposed rule, the change in terminology also makes our definition of breeding flock in § 56.1 consistent with our definition of multiplier breeding flock in § 145.1.
The March 2016 proposed rule included a minor change to § 145.12, which contains requirements for the retention and examination of records for all flocks maintained primarily for hatching eggs. We proposed to specify, in paragraph (b) of that section, that records for all breeder flock hatcheries must be made available for annual examination by a State inspector. Historically, testing records were retained at the hatchery, which allowed for examination of the records during annual inspections, but that is no longer the case. Many commercial hatcheries now keep testing records at the corporate office or another site. Our proposed amendment to § 145.12 was intended to reflect this change in recordkeeping practices in the industry and also to allow flexibility in the regulations regarding who may make the records available to the State inspector.
The commenter objected to this proposed change, stating that the Start Printed Page 53248records should be kept at the hatchery with the flocks so that taxpayers do not have to incur additional costs due to the need for inspectors to travel to different locations.
We do not agree with this comment. As noted above, we are amending the regulations to reflect current practices in the industry. By allowing hatcheries the discretion to maintain records where they would most readily be accessible when needed, we are relieving a regulatory burden. The commenter provides no evidence to support the claim that having the records kept at sites other than the hatcheries will result in additional costs to taxpayers.
The commenter also stated that the proposed rule would have the effect of loosening testing standards, thereby increasing the risk of the spread of disease.
We did not propose to loosen existing testing standards, as the commenter claims. We proposed instead to make some editorial changes to § 145.14(b) to remove references to tests that are no longer being used, update terminology that is no longer current, and otherwise clarify the testing requirements in that section.
Finally, the commenter objected to our proposed changes to the slaughter plant inspection requirements in § 146.11.
We will not be making any changes to the final rule in response to this comment. The commenter did not offer a rationale for opposing the proposed amendments to § 146.11, which were intended to clarify our slaughter plant inspection requirements and remove language that conflicted with requirements set out elsewhere in part 146.
In this final rule, we are making one minor editorial change to correct an error in the regulatory text of the proposed rule.
Section 146.11 sets out the audit process for participating slaughter plants. Paragraph (b) states that flocks slaughtered at a slaughter plant will be considered to be not conforming to the required protocol of the classifications if there are no test results available, if the flock was not tested within 21 days before slaughter, or if the test results for the flocks were not returned before slaughter. We intended to amend paragraph (b) to state that “a flock will be considered to be conforming to protocol if it meets the requirements as described in §§ 146.33(a), 146.43(a), 146.53(a).” However, we inadvertently referred to § 145.33(a) instead of § 146.33(a). In this final rule, we are correcting that error.
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 2014 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 on behalf of Plan members; that is, the changes were recognized by the poultry industry as being in their interest.
In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection or recordkeeping requirements included in this final rule, which were filed under 0579-0445, have been submitted for approval to the Office of Management and Budget (OMB). 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.
Start Part Start Printed Page 53249
2. Section 56.1 is amended by revising the definition of breeding flock to read as follows:
Breeding flock. A flock that is composed of stock that has been developed for commercial egg or meat production and is maintained for the principal purpose of producing progeny for the ultimate production of eggs or meat for human consumption.
4. In § 145.2, paragraph (d) is amended by removing the reference “§ 145.3(d)” and adding the reference “§ 145.3(e)” in its place.
5. Section 145.3 is amended as follows:
a. By redesignating paragraphs (a) through (f) as paragraphs (b) through (g), respectively.
b. By adding a new paragraph (a).
6. Section 145.12 is amended by adding, in paragraph (b), the words “made available to and” before the word “examined”.
a. By revising paragraph (a)(5).
(5) The official blood test shall include the testing of a sample of blood from each bird in the flock: Provided, That under specified conditions (see applicable provisions of §§ 145.23, 145.33, 145.43, 145.53, 145.63, 145.73, 145.83, and 145.93) the testing of a portion or sample of the birds may be used in lieu of testing each bird.
(1) The official tests for M. gallisepticum, M. meleagridis, and M. synoviae shall be the serum plate agglutination test, the hemagglutination inhibition (HI) test, the enzyme-linked immunosorbent assay (ELISA) test,[3] or a molecular based test. The HI test or molecular based test shall be used to confirm the positive results of other serological screening tests. HI titers of 1:40 or more may be interpreted as suspicious, and final judgment must be based on further samplings and/or culture of reactors. Tests must be conducted in accordance with this paragraph (b) and in accordance with part 147 of this subchapter.
8. In § 145.42, paragraph (b) is revised to read as follows:
(b) Hatching eggs should be nest clean. They may be fumigated in accordance with part 147 of this subchapter or otherwise sanitized.
9. Section 145.53 is amended as follows:
a. By revising paragraphs (c)(1)(i), (c)(1)(ii) introductory text, and (c)(1)(ii)(A).
b. By revising paragraphs (d)(1)(i), (d)(1)(ii) introductory text, and (d)(1)(ii)(A).
(i) It is a flock in which all birds or a sample of at least 300 birds has been tested for M. gallisepticum as provided in § 145.14(b) when more than 4 months of age or upon reaching sexual maturity: Provided, That to retain this classification, a random sample of serum or egg yolk or a targeted bird sample of the choanal palatine cleft/fissure area using appropriate swabs from all the birds in the flock if the flock size is less than 30, but at least 30 birds, shall be tested at intervals of not more than 90 days: And provided further, That a sample comprised of less than 30 birds may be tested at any one time, with the approval of the Official State Agency and the concurrence of the Service, provided that a total of at least 30 birds, or all birds in the flock if flock size is less than 30, is tested within each 90-day period; or
(ii) It is a multiplier breeding flock which originated as U.S. M. Gallisepticum Clean baby poultry from primary breeding flocks and a random sample comprised of 50 percent of the birds in the flock, with a maximum of 200 birds and a minimum of 30 birds per flock or all birds in the flock if the flock size is less than 30 birds, has been tested for M. gallisepticum as provided in § 145.14(b) when more than 4 months of age or upon reaching sexual maturity: Provided, That to retain this classification, the flock shall be subjected to one of the following procedures:
(A) At intervals of not more than 90 days, a random sample of serum or egg yolk or a targeted bird sample of the choanal palatine cleft/fissure area using appropriate swabs from all the birds in the flock if flock size is less than 30, but at least 30 birds, shall be tested; or
(i) It is a flock in which all birds or a sample of at least 300 birds has been tested for M. synoviae as provided in § 145.14(b) when more than 4 months of age or upon reaching sexual maturity: Provided, That to retain this classification, a random sample of serum or egg yolk or a targeted bird sample of the choanal palatine cleft/fissure area using appropriate swabs (C.P. swabs) from all the birds in the Start Printed Page 53250flock if flock size is less than 30, but at least 30 birds, shall be tested at intervals of not more than 90 days: And provided further, That a sample comprised of less than 30 birds may be tested at any one time with the approval of the Official State Agency and the concurrence of the Service, provided that a total of at least 30 birds is tested within each 90-day period; or
(ii) It is a multiplier breeding flock that originated as U.S. M. Synoviae Clean chicks from primary breeding flocks and from which a random sample comprised of 50 percent of the birds in the flock, with a maximum of 200 birds and a minimum of 30 birds per flock or all birds in the flock if the flock is less than 30 birds, has been tested for M. synoviae as provided in § 145.14(b) when more than 4 months of age or upon reaching sexual maturity: Provided, That to retain this classification, the flock shall be subjected to one of the following procedures:
(A) At intervals of not more than 90 days, a random sample of serum or egg yolk or a targeted bird sample of the choanal palantine cleft/fissure area using appropriate swabs from all the birds in the flock if the flock size is less than 30, but at least 30 birds shall be tested: Provided, That a sample of fewer than 30 birds may be tested at any one time with the approval of the Official State Agency and the concurrence of the Service, provided that a total of at least 30 birds, or the entire flock if flock size is less than 30, is tested each time and a total of at least 30 birds is tested within each 90-day period; or
10. Section 145.83 is amended as follows:
a. By revising paragraph (f)(1)(i).
b. By removing paragraphs (f)(1)(ii) and (f)(1)(iii).
c. By redesignating paragraphs (f)(1)(iv) through (f)(1)(viii) as paragraphs (f)(1)(ii) through (f)(1)(vi).
d. In newly redesignated paragraphs (f)(1)(v) and (f)(1)(vi) by removing the words “(f)(1)(vi)” and adding the words “(f)(1)(iv)” in their place.
e. By revising paragraph (f)(3).
(i) Measures shall be implemented to control Salmonella challenge through feed, feed storage, and feed transport.
(3) In order for a hatchery to sell products of paragraphs (f)(1)(i) through (f)(1)(vi) of this section, all products handled shall meet the requirements of the classification.
11. In § 145.92, paragraph (b) is revised to read as follows:
(b) Hatching eggs produced by primary and multiplier breeding flocks should be nest clean. They may be fumigated in accordance with part 147 of this subchapter or otherwise sanitized.
12. In § 145.93, paragraph (c)(3) is amended by removing the number “30” and adding the number “11” in its place.
14. Section 146.1 is amended by revising the definition of poultry to read as follows:
15. Section 146.2 is amended by revising paragraph (c) to read as follows:
16. In § 146.3, paragraph (a) is amended by adding the words “commercial table-egg layer pullet flock,” before the words “table-egg producer”.
17. In § 146.11, paragraph (b) is revised to read as follows:
(b) A flock will be considered to be conforming to protocol if it meets the requirements as described in § 146.33(a), § 146.43(a), or § 146.53(a).
18. Section 146.51 is amended as follows:
a. In the definition of commercial upland game birds by removing the word “purpose” and adding in its place “purposes” and adding the words “eggs and/or” before the word “meat”.
b. In the definition of commercial waterfowl, by removing the word “purpose” and adding in its place “purposes” and adding the words “eggs and/or” before the word “meat”.
19. Section 146.52 is amended by revising paragraphs (a) and (c) to read as follows:
20. Section 146.53 is amended as follows:
a. In paragraph (a) introductory text, by adding the words “or, in the case of egg-producing flocks, the regular surveillance of these flocks” after the words “participating slaughter plant”. Start Printed Page 53251
b. By adding paragraphs (a)(4) and (a)(5).
(4) It is a commercial upland game bird or waterfowl flock that produces eggs for human consumption where a minimum of 11 birds per flock have been tested negative to the H5/H7 subtypes of avian influenza as provided in § 146.13(b) within 30 days of disposal or within a 12 month period.
21. The authority citation for part 147 continues to read as follows:
22. In § 147.52, paragraph (d) is revised to read as follows:
23. Section 147.54 is revised to read as follows:
(1) The sensitivity of the kit will be evaluated in at least three NPIP authorized laboratories by testing known positive samples, as determined by the official NPIP procedures found in the NPIP Program Standards or through other procedures approved by the Administrator. Field samples for which the presence or absence of the target organism or analyte has been determined by the current NPIP test should be used, not spiked samples or pure cultures. Samples from a variety of field cases representing a range of low, medium, and high analyte concentrations should be used. In some cases it may be necessary to utilize samples from experimentally infected animals. Spiked samples (clinical sample matrix with a known amount of pure culture added) should only be used in the event that no other sample types are available. Pure cultures should never be used. Additionally, laboratories should be selected for their experience with testing for the target organism or analyte with the current NPIP approved test. If certain conditions or interfering substances are known to affect the performance of the kit, appropriate samples will be included so that the magnitude and significance of the effect(s) can be evaluated.
(2) The specificity of the kit will be evaluated in at least three NPIP authorized laboratories by testing known negative samples, as determined by tests conducted in accordance with the NPIP Program Standards or other procedures approved by the Administrator in accordance with § 147.53(d)(1). If certain conditions or interfering substances are known to affect the performance of the kit, appropriate samples will be included so that the magnitude and significance of the effect(s) can be evaluated.
(3) The kit will be provided to the cooperating laboratories in its final form and include the instructions for use. The cooperating laboratories must perform the assay exactly as stated in the supplied instructions. Each laboratory must test a panel of at least 25 known positive samples. In addition, each laboratory will be asked to test at least 50 known negative samples obtained from several sources, to provide a representative sampling of the general population. The cooperating laboratories must perform a current NPIP procedure or NPIP approved test on the samples alongside the test kit for comparison.
(4) Cooperating laboratories will submit to the kit manufacturer all raw data regarding the assay response. Each sample tested will be reported as positive or negative, and the official NPIP procedure used to classify the sample must be submitted in addition to the assay response value. A completed worksheet for diagnostic test evaluation is required to be submitted with the raw data and may be obtained by contacting the NPIP Senior Coordinator. Raw data and the completed worksheet for diagnostic test evaluation must be submitted to the NPIP Senior Coordinator 4 months prior to the next scheduled General Conference Committee meeting, which is when approval will be sought.
(5) The findings of the cooperating laboratories will be evaluated by the NPIP Technical Committee, and the Technical Committee will make a majority recommendation whether to approve the test kit to the General Conference Committee at the next scheduled General Conference Committee meeting. If the Technical Committee recommends approval, the final approval will be granted in accordance with the procedures described in §§ 147.46, 147.47, and 147.48.
(3) Approved diagnostic tests may be removed from the Plan by submission of a proposed change from a participant, Official State Agency, the Department, or other interested person or industry organization. The data in support of removing an approved test will be compiled and evaluated by the NPIP Technical Committee, and the Technical Committee will make a majority recommendation whether to remove the test kit to the General Conference Committee at the next scheduled General Conference Committee meeting. If the Technical Committee recommends removal, the final decision to remove the test will be granted in accordance with the procedures described in §§ 147.46, 147.47, and 147.48.
1. To view the proposed rule and the comment we received, go to http://www.regulations.gov/​#!docketDetail;​D=​APHIS-2014-0101.
[FR Doc. 2016-19245 Filed 8-11-16; 8:45 am]